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Concept Pharmaceuticals Ltd Report of In-Plant Training

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Concept Pharmaceuticals Ltd Report of In-Plant Training

TABLE OF CONTENT

 INTRODUCTION

 PERSONNEL DEPARTMENT

 PRODUCTION DEPARTMENT

 PURCHASE DEPARTMENT

 QUALITY CONTROL DEPARTMENT

 QAUALITY ASSURANCE DEPARTMENT

 MARKETING DEPATMENT

 SWOT ANALYSIS

 CONCLUSION

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Concept Pharmaceuticals Ltd Report of In-Plant Training

INTRODUCTION

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Concept Pharmaceuticals Ltd Report of In-Plant Training

Company Profile
1. GENERAL INFORMATION

1.1 The firm is titled as Concept Pharmaceuticals Limited.

The Registered Office of the firm is located at

167,CST ROAD
SANTACRUZ (EAST)
MUMBAI 400 098
INDIA

1.2 The firm is manufacturing various dosage forms for Indian Market as well as
Export market.

1.3 The manufacturing activities are being carried out at Factory located at
Aurangabad (Maharashtra State ). Food & Drug Administration has given licence
to the firm to manufacture for sale various dosage forms viz Tablets, Capsules ,
Dry powders , Liquid Orals External preparations, injectables , Animal Health
Products and Ampicillin Sodium Sterile Bulk Drug.

1.4 Factory is located at


Concept Pharmaceuticals Limited
A-28/3, MIDC Area,
Chikalthana,
Aurangabad - 431 210.
Maharashtra State.
Ph.No. 0240 - 2485 671 / 2485 071
Fax 0240 - 2484 240
Email admin@conceptpharma.net.in

24 hours Telephone No. 2485 671 (Office)


Person to be contacted : Mr.S.A.Shaikh
Designation : GM-Q.A./ R & D

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Concept Pharmaceuticals Ltd Report of In-Plant Training

1.5 Following type of products are being manufactured at this site

Tablets - coated & uncoated


Capsules
Dry Syrups
Liquid Orals
External Preparations (Ointments , Creams )
Liquid and Powder Injectables.
Ayurvedic Products
Animal Health Products.

No toxic or hazardous products are being manufactured at the site.

1.6 The site is located on MIDC plot bearing No. A-28/3 in Chikalthana Industrial
Area of Aurangabad (MS).
The total area of the plot is 2.24 Hectors. The immediate environment of the site is
free from pollution. The units located on adjacent plots are not generating any
pollutants, fumes gases etc. The site is holding a consent from Maharashtra
Pollution Control Board, a Statutory body monitoring environmental air and water
pollution.

1.7 Following number of employees are engaged on site to carry out various
operations
Production 117
Quality Control 017
Quality Assurance 005
Stores and Distribution 014
Engineering 013
R&D Formulation 005
R&D Bulk Drugs 016
Personnel & Admn. 012
Factory Management Team 002
-------------
Total 201
=======

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Concept Pharmaceuticals Ltd Report of In-Plant Training

1.8 The Quality Assurance Dept/ Quality Control Dept located at site is well
equipped to carry out all the required analytical work. At instances, assistance
from Govt. approved Public Testing Laboratories is also taken, when facilities to
carry out specific tests are not available on site.

In such cases we normally use services of


Name and Address of the Laboratory :
1) M/s. Bee Pharmo Labs Pvt.Ltd.
5-6-7 Kakad Estate, R G Thadani Marg,
Worli, Mumbai 400 018, Mumbai.

2) Manisha Analytical Laboratories Pvt. Ltd.


135 A, Govt. Industrial Estate, Charkop,
Kandivali (West), Mumbai –400060,
Tel- 2869 9888, 28602292
Fax- 2869 5296.
E-mail – malab@vsnl.com
Website-WWW.manishalab.com

1.9 Concept is well equipped for manufacturing Quality goods. Its Quality Control
and manufacturing Dept. are having all the required facilities for ensuring the
desired and consistent quality of all the produces. We therefore, have well-
designed system of Quality Assurance incorporating GMP & Quality Control. It
is being monitored effectively and documented.

1.9.1. All the incoming raw materials are procured from approvedvendors. These inputs
are subjected to stringent and thorough Quality Checks prior to releasing them for
manufacturing.

1.9.2 .There is a well designed inprocess checks system to monitor the manufacturing
stages in order to ensure desired and consistent Quality of the products being
manufactured.

1.9.3. The samples are withdrawn for final checks by quality control and only after
confirming the total compliance the batches are released for market.

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Concept Pharmaceuticals Ltd Report of In-Plant Training

1.9.4. All the operating procedures are standardised validated and well documented.
These standard procedures are strictly followed during the total operations and
a record is maintained to that effect.

1.9.5. All the Machinery, Equipment’s, Instruments used for processing and Quality
checks are subjected to periodic calibrations.

1.9.6. The workforce is well trained to carry out the manufacturing activities in the
prescribed manner. Their knowledge is updated through periodic training
programmes.

1.9.7. All the manufacturing and analysis activities are carried out under the direct
supervision of team of Technically Competent Persons.

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Concept Pharmaceuticals Ltd Report of In-Plant Training

ABOUT THE ORGANIZATION

Concept was launched as an independent entity in 1984 by Shri A. B. Gupta who had
earlier experience as founder director of Lupin Group of Companies.

Initially launched as a marketing company it has expanded its activitities to emerge as a


strong multi-divisional group with excellent infrastructure. Its activities include:

Ethical Pharmaceutical : Covers around 60% of all the therapeutic groups has launched
a number of innovative products.

Animal Health Division : Is one of the top 10 domestic companies in this area.

APIs Division : Infrastructure and knowledge base in manufacturing sterile and non
sterile products.

Herbal Division: Innovative herbal products to treat lifestyle conditions.

Institution & hospital division :Caters to the needds of large public institutions as well
as private hospitals.

Medical electronics : Handling range of critical care products such as Cardiac Monitors,
Treadmills, Oximeters etc.

These activities are supported with a strong infrastructure such as 5 manufacturing plants,
17 branch offices/distribution centres, 400 strong marketing force throughout the country
meeting 50,000 doctors every month supported by a network of around 1000 stockists.

In addition the company is putting lot of thrust towards R&D efforts and has successfully
launched few technologies, first time in the country through its own government
approved R&D centres.

Our Pharmaceutical marketing covers majority of the therapeutic areas. We have a strong
and well trained field force of more than 350 personnel which cover more than 60,000
doctors every month.

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Concept Pharmaceuticals Ltd Report of In-Plant Training

We enjoy leadership position in the pediatric Anti-Tubercular market. While competitors


in this therapeutic segment concentrate only on cure of infection, Concept goes beyond
cure of infection by focusing on improved quality life of patient, through B6 safeguard
against peripheral neuropathy and convenience of administration.

Concept was the first company in the world to introduce Oflab the combination of
Ofloxacin and Lactobacillas. This innovation is welcomed by medical professions as and
is used to make the patient feel better because Lactobacillas takes care of the abdominal
discomfort normally experienced by patient on Ofloxacin. Concept also has a strong
position in the cephalosporin market.

Mission and Strategy

"We will discover, develop and successfully market pharmaceutical products to prevent,
diagnose, alleviate and cure diseases.

We shall provide total customer satisfaction and achieve leadership in chosen markets,
products and services across the globe, through excellence in technology, based on
world-class research and development.

We are responsible to the society. We shall be good corporate citizens and will be driven
by high ethical standards in our practices."

" Is to provide products of international quality for better health care of Livestock and
Poultry, at most economical price so that farmers can earn higher profits due to improved
productivity "

Code of Conduct

As required under revised Clause 49 of the Listing Agreement the following


code of conduct has been approved by the Board of Directors and is applicable to
the Directors and Senior Management of the Company.

Ethical conduct

All directors and senior management employees shall deal on behalf of the
Company with professionalism, honesty, integrity as well as high moral and
ethical standards. Such conduct shall be fair and transparent and be perceived to
be as such by third parties.

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Concept Pharmaceuticals Ltd Report of In-Plant Training

Conflict of interest

Any director or senior management employee of the Company shall not engage in
any business, relationship or activity, which might detrimentally conflict with the
interest of the Company.

Transparency

All directors and senior management employees of the Company shall ensure that
their actions in the conduct of business are totally transparent except where the
needs of business security dictate otherwise. Such transparency shall be brought
about through appropriate policies, systems and processes.

Legal compliance

All directors and senior management employees of the Company shall at all times
ensure compliance with all the relevant laws and regulations affecting operations
of the Company. They shall abreast of the affairs of the Company and be kept
informed of the Company's compliance with relevant laws, rules and regulations.
In the event that the implication of law is not clear, the course of action chosen
must be supported by eminent legal counsel whose opinion should be documented.

Rightful use of company’s assets

All the assets of the Company both tangible and intangible shall be employed for
the purpose of conducting the business for which they are duly authorized. None
of the assets of the Company should be misused or diverted for personal purpose.

Cost consciousness

All the directors and senior management employees of the Company should strive
for optimum utilization of available resources. They shall exercise care to ensure
that costs are reasonable and there is no wastage. It shall be their duty to avoid
ostentation in Company expenditure.

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Concept Pharmaceuticals Ltd Report of In-Plant Training

Confidential information

All directors and senior management employees shall ensure that any confidential
information gained in their official capacity is not utilized for personal profit or
for the advantage of any other person. They shall not provide any information
either formally or informally to the press or to any other publicity media unless
specifically authorized to do so. They shall adhere to the provisions of SEBI
(Prohibition of Insider Trading) Regulations, 1992.

Relationships with Suppliers and Customers

The Directors and senior management employees of the Company during the
course of interaction with suppliers and customers, shall neither receive nor offer
or make, directly and indirectly, any illegal payments, remuneration, gifts,
donations or comparable benefits which are intended or perceived to obtain
business or uncompetitive favours for the conduct of its business. However this is
not intended to include gifts of customary nature.

Interaction with Media

The Directors and senior management employees other than the designated
spokespersons shall not engage with any member of press and media in matters
concerning the Company. In such cases, they should direct the request to the
designated spokespersons.

Safety and Environment

The Directors and senior management employee shall follow all prescribed safety
and environment-related norms.

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Concept Pharmaceuticals Ltd Report of In-Plant Training

Pharmaceutical Division
It is the core activity with strong thrust for ethical marketing. It has a strong presence in
the therapeutic group such as
1. Anti-tubercular
2. Antibiotics
3. Antacids & Antiulcerants
4. Cough preparations
5. Analgesic & Anti-inflammatory drugs
6. Cardiovascular drugs.

The company has successfully launched quite a few products for the first time in the
country as a result of innovative ideas through R&D efforts

 Range of pediatric dispersible tablets.

 Rifa I-6 kid & Rifa I-kidforte -- combination of Rifampicin, Isonaizide & Vitamin B6.

 Roxyrol 50 & 75 mg -- Roxythromycin 50 & 75 mg.

 Ibuplus kid – Ibuprofen plus Paracetamol.

 Fluzide 50 mg D.T – Fluconazole 50 mg (D.T)

 Disogel – only antacid with cyto protective DGL.

 Clarex – herbal anti acne cream.

 Ajar – herbal antioxidant, immunomodulator & antidepressant.

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Concept Pharmaceuticals Ltd Report of In-Plant Training

Registered in centers such as


1. Africa :

Ghana
Nigeria
Sudan
Kenya
Ethiopia
Uganda
Zambia

2. Asia :

Srilanka
Myanmar
Cambodia
Singapore
Malaysia
Philippines
Thailand

3. C.I.S. Countries :

Ukraine

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Concept Pharmaceuticals Ltd Report of In-Plant Training

MANAGERIAL TEAM OF CONCEPT PHARMACEUTICAL


LIMITED

Mr. A.B. GUPTA – Chairman and Vice President

Personnel Department :
Mr. S.U. Joshi – HRD Manager
Mr. A.H. Baghwan – Executive Officer

Finance Department :
Mr. Kamlesh Kurani – General Manger
Mr. Katare – Executive Officer

Production Department :
Mr. M.M. Atre – Vice President
Mr. S.A. Shaikh – General Manager
Mr. J.P. Lal – Deputy General Manager
Mr. M.G. Umapurkar – Executive Officer
Mr. S. Bakal – Executive Officer

Marketing Department :
Mr. Ajay Kumar – Vice President
Mr. Amit Vyas – Product Manager
Mr. Deepak Parab – RSM
Mr. S.K. Gupta – ASM

QA Department :
Mr. V.L. Pathak – Manager
Mr. Pravin Mewade – Senior Executive Officer

QC Department :
Mr. S.J. Koshti – Manager
Mr. D.M. Shastri – Senior Executive Officer

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Concept Pharmaceuticals Ltd Report of In-Plant Training

ABBREVATIONS USED IN MODULAR PLAN

1. R.D (F.C.) = Research & Development Department (Fine Chemicals)


2. INT = Instrument room
3. R.D.(F) = Research & Development Department (Formulation)
4. ENT = Entrance
5. QA = Quality Assurance Department
6. PDN CAB = Production Department Cabin
7. EDP = Electronic Data Processing Department
8. C.R. = Change Room
9. CAN = Canteen
10. W = Way
11. I.P.Q.C = In Process Quality Control
12 Q.C = Quality Control Department
13. T = Toilet
14. BSR = Bonded Storage Room
15. STR = Store
16. OINT = Ointment Production Room
17. GRA = Granulation Area
18. COM = Compression Area
19. DSF = Dry syrup Filling Area
20. COA = Coating Area
21. CAP = Capsule Production Department
22. PAR = Parentaral Department
23. BULK = Bulk Department
24. PKG = Packing Department
25. LQD = Liquid Oral Department
26. C = Cabin

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Concept Pharmaceuticals Ltd Report of In-Plant Training

PRODUCT LIST
Some of the examples of the products are given:

1) ANTI-TB RANGE

PRODUCTS DETAILS
RIFACEPT3 3 drug anti T.B therapy
RIFA 1-6 FORTE For adults above 50 kg body weight
RIFA 1-6 For adults unto 50 kg body weight
RIFA 1-6 KID FORTE Childhood T.B with Vitamin B6 f0r 20 kg
body weight
RIFA 1-6 KID Childhood T.B with Vitamin b6 for 10 kg
body weight
RIPECEPT KID3 First 3 drugs anti T.B with Vitamin B6 for
childhood tuberculosis.

2) GASTRO-INTESTINAL

PRODUCTS DETAILS
DISOGEL SYRUP For acid peptic disorder
DISOGEL TABLETS ,,
PANTEC 20 Pantoprazole delivered at duodenum

3) COUGH SYRUPS

PRODUCTS DETAILS
SYNABORN TABLETS Clears blockade fast & ends cough
completely
SYNABRON TABLETS Ends the cough completely
SYNABRON M For total reform cough & cold
SYNABRON D Stops cough & cold.

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Concept Pharmaceuticals Ltd Report of In-Plant Training

4) HERBAL

PRODUCTS DETAILS
AJAR CAPSULES Spirulina potentiated stress bluster
CLAREX CREAM Cleans pimples, better complexion
HEPACEF SYRUP Keeps liver safe
HEPACEF TABLETS Keeps hepa safe.

5) ANTI-BACTERIALS

PRODUCTS DETAILS
ROXYROL 50 Dispersible Roxythromycin for age 5 yrs
BROMOXYL Awaiting punch line
ROXYROL 75 Dispersible Roxythromycin for age 5-12
yrs.

6) ANTI-FUNGAL

PRODUCTS DETAILES
FLUZIDE 200 Eradicates fungi
FLUZIDE 150 Treatment for any fungi
FLUZIDE T In mixed vaginitis
FLUCREAM NM Eradicates infection in mixed skin
infections

7) CARDIOVASCULAR

PRODUCTS DETAILES
CARDIF Calcium blockade + beta blockade
CARDIF BETA ,,
ASPICOT 80 Enteric coated aspirin for anti-platelet
activities
LPL 10 Most preferred ACE inhibitor
LPL 2.5 ,,

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Concept Pharmaceuticals Ltd Report of In-Plant Training

8) ANTI-INFLAMMATORY

PRODUCTS DETAILES
IBUCON KID Faster activity antipyretic
IBUCON PLUS Faster acting antipyretic
IBUCON 200 PLUS For tender stomach
IBUCON 400 Extra power anti-inflammatory analgesic

9) ANIMAL HEALTH PRODUCTS

PRODUCTS DETAILES
PEPSID, LEPTAMILK Tonics
PYRENIL Faster acting antipyretic
CURADEX Anti-inflammatory
CONAMPI Antimicrobial

GENERIC DIVISION

1) ANTIBIOTICS

BRAND INGREDIENTS QTY


C-MOX Amoxicillin 250/500 mg Capsule
GENCIN Gentamicin 10ml/30ml Injection
CEPHACON Cephalexin 125/250 mg kid tablet

2) ANTIBACTERIALS

BRAND INGREDIENTS QTY


ULTIFLOX Ciprofloxacin 250/500 mg tablet
COPRIME Cotrimoxazole 60 ml suspension

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Concept Pharmaceuticals Ltd Report of In-Plant Training

3) ANTI T.B RANGE

BRAND INGREDIENTS QTY


RIFACON Rifampicin 450 mg
Isoniazid 300 mg Capsule
ULTICOX Ethambutol 800 mg Tablet

4) NUTRACEUTICALS

BRAND INGREDIENTS QTY


MEGASULES High dose B-complex & Capsule
Vit-C
SAMVIT Multivitamin Capsule

5) COUGH & COLD

BRAND INGREDIENTS QTY


KONCIDRYL Diphenhydramine 100 ml cough syrup

6) ANTIDIARRHOEALS

BRAND INGREDIENTS QTY


NORE-T Norfloxacin 400 mg tablet
CONCIZOLE Metronidazole 200 mg& 400 mg tablet

7) ANTI-ULCERANTS

BRAND INGREDIENTS QTY


RANCAFE Ranitidine 150 mg tablet/injection

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Concept Pharmaceuticals Ltd Report of In-Plant Training

MANUFACTURING PLANTS

 Three manufacturing plants covering all type of dosage forms approved for
G.M.P as per W.H.O standards since 1992.

 Aurangabad (Chikalthana) plant located 5 km from city. Land of around 15 acres


with manufacturing facility of around 1,00,000 square feet. Here the majority of
production for Concept Pharmaceuticals Ltd is done . Plants have Drug dosage
forms such as Tablet, Capsule & Dry syrup.

 Aurangabad (Chittegaon) 10 km from city center on Paithan road. Around 10


acres. Manufacturing facility of 20,000 square feet. Here the majority of
production is of Rifampicin (Anti Tuberculosis drug) is been carried out.

 Birganj (Nepal) plant on the main highway connecting Birganj to Kathmandu


about 5 km from Birganj. The first plant to be approved for W.H.O & G.M.P
standards in Nepal.

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Concept Pharmaceuticals Ltd Report of In-Plant Training

PERSONNEL DEPARTMENT

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Concept Pharmaceuticals Ltd Report of In-Plant Training

House Keeping
1. Objective : To provide standing operating procedure for good house keeping to
facilitate

Manufacturing operations in orderly manner

Cleaning and disinfection of the premises

Maintenance of the clean and hygienic environment for working.

2. Scope : This is applicable to plant and premises

3. Responsibility : House keeping incharge is responsible for the house keeping of


the total premises

4. Procedure :

Place dust bins at all appropriate and required locations duly labeled as “Dust
Bins”. Remove dust bins and empty it at fixed intervals.

Ensure insectocutors at all the appropriate and required points are working. Collect
trays of such insectocutors and empty it periodically.

Ensure fire fighting equipments of appropriate type at all the required locations. Refill
such equipments periodically and maintain the record.

Provide door mats at all the required exits and entries.

Demark predetermined places for storage of different places for storage of different
categories of materials and accordingly put the materials there only.

Pull all the waste collected from various locations at point and then dispose of as per
the procedure given under the SOP titled as “Waste Disposal”.

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Concept Pharmaceuticals Ltd Report of In-Plant Training

TRAINIG AND DEVELOPMENT OF PLANT


PERSONNEL
1. Objective : To lay down the standard operating procedure for training of all plant
personnel.

2. Scope : All employees of the factory.

3. Responsibility : HRD manager is responsible for the training and development of


plant personnel.

4. Procedure : The following procedure is followed for training and development of


employees.

Training needs of the employees are identified from the performance appraisals of the
employees and through observations of the chief of the plant.

Assess the training needs of the employees and prepare the training calendar for all
employees of the company.

Organize the training programmes with the help of the internal as well as external
resources.

Maintain the record of each internal programme conducted .


Maintain the record of training of each employee as in from T1.

Send employees for training / seminars and workshops etc. organized by the external
professional agencies.

Evaluate each of such training program internally conducted in form T3.

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Concept Pharmaceuticals Ltd Report of In-Plant Training

JOB DESCRIPTION AND MANAGEMENT


RESPONSIBILITIES OF TECHNICAL PERSONS
1. Objective : To provide job description and management responsibilities of
technical persons.

2. Scope : Applicable to job responsibilities of all senior technical persons.

3. Responsibilities : HRD Manager.

4. Procedure : The job responsibilities of all senior technical persons are to be


written down as the same is essential for smooth, error free working, to make the
person responsible / accountable for the particular activity. Well defined job
responsibilities avoid confusion in working and everybody becomes aware his
own area of work.

A. Vice President

The person reports to Chairman and Managing Director.


He is overall responsible for the following functions :

A.1. Overall functioning of the factory


A.2. Co-ordination between various section heads at Head Office And Factory
A.3. Production of all dosage forms
A.4. Commercial activities
A.5. Engineering services
A.6. Stores services
A.7. Distribution services
A.8. Overall factory administration

Following officials reports to Vice President :


A.1. Deputy General Manger – Engineering Operations
A.2. Deputy General Manger – Manufacturing
A.3. General Manger – Q.A and R&D
A.4. Manager – Q.C.
A.5. Senior Manager – Formulation Development (Herbal)
A.6. Manager – Commercial
A.7. Deputy General Manager (HR & Adm)

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Concept Pharmaceuticals Ltd Report of In-Plant Training

Deputy General Manager – Engineering Operations

The person reports to Vice President of the Organisation.


The members of Engineering team shall be reporting to him.
The person is responsible for :

1. Planning of day to day activity


2. Maintenance of equipments, machineries, utilities provided for manufacturing
3. Designing and implementing of preventive maintenance schedule
4. Attending break down maintenance calls
5. Procurement of right equipment and installation of new machineries
6. Monitoring and maintenance of energy sources
7. Maintenance of pollution free atmosphere
8. water treatment and discharge of effluents
9. Liaisoning with government bodies i.e., Electricity Board, Boiler Officers, MPCB
10. Planning timely commissioning of projects.

Deputy General Manager – Manufacturing

DGM – Mfg, Reports to Vice president of the Organisation.


The members of production team report to him.
The person s responsible for :

1. Preparation of the monthly production schedule carrying out of production


activities as per the plan
2. Manufacturing of the product as per the SOP’s to achieve the specified yield and
quality norms
3. Maintenances of the batch manufacturing records
4. Following of GMP requirements
5. Upkeeping of the equipments, area and other facilities
6. Training and development of employees working in production
7. Packing of all the dosage form as per the standard packing procedure.

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Concept Pharmaceuticals Ltd Report of In-Plant Training

General Manager – QA and R&D

The person reports independently to Vice President of the factory.


The person is responsible and authorized for QA and R&D functions
All the members of QA sand R&D team report to him
The person is responsible for:

(Q.A responsibilities)

1. Approving or rejecting all the procedures of specifications impacting on the


identity, strength, quality and purity of the drug products
2. Review of production records to assure that no errors have occurred during
manufacturing of the product or if errors have occurred, that they have been
fully investigated
3. Implementation of all the requirements of good manufacturing practices and
good laboratory practices
4. Attending the market complaints, investigation thereof, and implementation of
corrective steps
5. Recall of the products found to be not of standard quality
6. Liaisoning with FDA.

Formulation Development :

The person is responsible for development of new products, improvements of existing


products.
All the members of R&D team report to him.
The person is responsible for :
1. Development of new products
2. Designing the specifications for raw materials, packing materials, semi finished
products and finished products
3. Designing the standard manufacturing procedure for manufacturing of the
products
4. Validation of process equipments and processes.

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Concept Pharmaceuticals Ltd Report of In-Plant Training

Manager Quality Control :


Approval or rejection of all raw material inputs, packaging material inputs, inprocess
materials and finished products manufactured, processed, packed or held under contract
by another company.

Sr.Manager – Formulation Development (Herbal)


The person reports to General Manager QA and R&D
The person is responsible for the development of new products, improvement of existing
products.

The person is responsible for :


1. Development of new products
2. Designing the specifications for raw materials, packaging materials, semi finished
products and finished products
3. Designing the standard manufacturing procedure for manufacturing of the
products
4. Validation of process equipments and processes.

Manager-- Commercial
The person reports to the Vice President of the factory.
The team of purchase, accounts, distribution reports to him.

The person is responsible for :


1. Purchasing of consumables, engineering spares, utility items and corrugation as
per the need from approved vendors
2. Maintenance of accounts, banking services
3. Compliance with various taxations including excise, sales tax, income tax
4. Liaisoning with the govt. agencies regulating the various taxes
5. Receipt, identification and storage of all the raw material and packing materials
6. Storage of materials under specified conditions of storage
7. Handling of the materials as per their release status
8. Dispensing of the materials to production dept.
9. Maintenance of inventory records
10. Following of FIFO system in issuance of the materials
11. Return of the rejection materials
12. Destruction of the obsolete materials
13. Upkeeping of area, equipments and facilities
14. Following of GMP requirements
15. Receipt of finished goods from packing dept.
16. Storage of finished goods under appropriate conditions of storage
17. Dispatches of finished good to various depots as per dispatch plan
18. Following of FIFO system in dispatching the goods
19. Maintenance of all the system and control records.

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Concept Pharmaceuticals Ltd Report of In-Plant Training

Deputy General Manager – HR & ADMIN.

The person reports to the Vice President of the factory.


The team of HR & Admin. Dept, security staff reports to him.

The person is responsible for :

1. Manpower planning of the factory


2. Identification and fulfilling the manpower requirements of various sections
through recruitments
3. Identification & fulfilling training needs of various personnel
4. Security & safety of the plant, machineries & personnel]
5. Maintenance of hygiene in the factory premises
6. Cleaning, maintenance & sanitation of the plant & premises
7. Providing canteen services to the employees
8. Liaisoning with govt. agencies
9. Organizing seminars on technical sessions & continues development of personnel
10. Effective communication inter & intra dept.

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Concept Pharmaceuticals Ltd Report of In-Plant Training

PERSONAL HYGIENE

1. Objective :
This SOP is prepared to have laid down standard procedure for personal hygiene
in order to avoid contamination, as pharmaceutical products are to be
manufactured in a clean, hygienic environment. Personal hygiene therefore attains
an important role in manufacturing of pharmaceutical products, & is a part of
cGMP.

2. Scope :
3. This SOP is applicable to all

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Concept Pharmaceuticals Ltd Report of In-Plant Training

PRODUCTION DEPARTMENT

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Concept Pharmaceuticals Ltd Report of In-Plant Training

TYPES OF DOSAGE FORMS MANUFACTURED

 TABLETS

 CAPSULES

 LIQUID ORALS

 OINTMENTS

 PARENTERALS

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TABLET DEPARTMENT

It is divided into:

 Material entry

 Dispensing area

 Granulation

 Compression

 Coating

 Packing

Master files worksheet & SOP’s are maintained for each product manufactured. It
contains the formula for active ingredients, test to be done on raw materials, procedure
for manufacturing, test to be on final products & other information necessary for the
manufacturing of each product.

The worksheet contains the materials work order, the area & the equipments
clearance charts, the manufacturing procedure with theoretical yield sheet to record
practical yield of granules & tablet, it also carries the Q.C reports at every step & the
final release for sale sheet.

Production department also maintains yield registers of various products


Stepwise, all machinery information, calibration report of equipment, production plan &
reports etc. for future reference.

They also standardize each sophisticated equipment like Disintegration apparatus,


Electronic balance, Moisture content measurement apparatus etc. before starting the
production each & every day.

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MAJOR MACHINERY AVAILABLE IN MANUFACTURING


OF TABLETS DEPARTMENT

FOR GRANULATION:

SL. Name Of Equipment Name of the Mfgr. Qty. Capacity


No.

1. Sifter 30” Dynamic Machine Pvt. Ltd 1 600 kg


2. Mass Mixer (200 kg Cap) Dynamic Machine Pvt. Ltd 1 200 kg
3. Planetary Mixer Beeter Machine Ltd. 1 200 kg
4. Rapid Micro Granulator SAM Machine 1 600 Ltr.
5. Paste Vessel Dynamic Machine Pvt. Ltd 1 100 Ltr.
6. Multi Mill RPM 3500 Pharma Electro 2 600 kg
7. Clit Mill Clit Machine 1 500 kg
8. Cad Mill Cadmach 1 500 kg
9. Fluid Bed Dryer Alliance Engineering Ltd. 2 100 kg
10. Octagonal Blender ESSAR 1 500 kg
11. I.P. Containers Dynamic Machine Pvt. Ltd 10 500 kg
12. Colloid Mill Dynamic Machine Pvt. Ltd 1 ---

FOR COMPRESSION:

SL. Name Of Equipment Name of the Mfgr. Qty. Capacity


No.

1. Cadmach DR. 35 ST’N Cadmach 1 8.4 Lakhs


2. Clit DR. 27 ST’N Clit Machine 1 5.4 Lakhs
3. Clit Press Clit Machine 1 7 Lakhs
4. Double Rotary St. Dynamic Machine Pvt. Ltd 1 4 Lakhs
Machine (Square Body)
5. Mini Rotary Machine Dynamic Machine Pvt. Ltd 1 ---
6. Double Rotary Machine Dynamic Machine Pvt. Ltd 1 3.0 Lakhs
7. Single Rotary Dynamic Machine Pvt. Ltd 1 1.7 Lakhs
Compression Machine
8. Single Rotary Dynamic Machine Pvt. Ltd 1 1.21
Compression Machine Lakhs

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Concept Pharmaceuticals Ltd Report of In-Plant Training

FOR COATING:

SL. Name Of Equipment Name of the Mfgr. Qty. Capacity


No.

1. Coating Pan SS 48” Dynamic Machine Pvt. Ltd 1 100 kg


2. Coating Pan SS 42” Dynamic Machine Pvt. Ltd 2 100 kg
3. Coating Pan SS 36” Dynamic Machine Pvt. Ltd 2 60 kg
4. Polishing Pan SS 48” Dynamic Machine Pvt. Ltd 1 100 kg

FOR PACKING:

SL. Name Of Equipment Name of the Mfgr. Qty. Capacity


No.

1. Tablet Printing Machine Mangnose Engg. Co. 1 8.0 Lakhs


2. Tablet Counting Balance Microweigh 1 2400
Bags
3. Blister Pack Machine Elmac 3 6.0
Lakhs/m/
c
4. Strip Sealing Machine Dynamic/Hemson 3 3.0
Lakhs/m/
c
5. Electronic Balance Eagle 1 500 kg

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Concept Pharmaceuticals Ltd Report of In-Plant Training

MAJOR MACHINERY AVAILABLE IN MANUFACTURING


OF CAPSULES/DRY SYRUPS DEPARTMENT

SL. Name Of Equipment Name of the Mfgr. Qty. Capacity


No.

1. Sifter 30” Dynamic Machine Pvt. Ltd 1 400 kg


2. Mass Mixer (100 kg Cap) Dynamic Machine Pvt. Ltd 1 100 kg
3. Tray Dryer Dynamic Machine Pvt. Ltd 1 100 kg
4. Mass Mixer Dynamic Machine Pvt. Ltd 1 150 kg
5. Capsule Filling Machine PAM Pharmaceuticals Ltd. 2 0.5 Lakhs
Allied Machine Co. Ltd. 1 0.5 Lakhs
Monita Industries 1 0.5 Lakhs
Dynamic Machine Pvt. Ltd 2 0.5 Lakhs
6. Capsule Counter Dynamic Machine Pvt. Ltd 4 0.5 Lakhs
7. Semiautomatic Capsule PAM Machine 1 1.44 Lakhs
Filling Machine
8. Semiautomatic Capsule Master Mechanical Works 2 0.1 Lakhs
Sealing Machine Ltd.
9. Belt Polishing Machine Pharma Chem India 1 1.5 Lakhs
10. Air Conditioner Pharma Chem India 2 ---
11. Dehumidifier Indian Equipment 2 ---
Corporation
12. Electronic Balance Mettler Machine 1 300 gm

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Concept Pharmaceuticals Ltd Report of In-Plant Training

MAJOR MACHINERY AVAILABLE IN MANUFACTURING


OF LIQUID ORAL DEPARTMENT

SL. Name Of Equipment Name of the Mfgr. Qty. Capacity


No.

1. Bulk Manufacturing &


Storage S.S Tanks
a) 6000 Ltr. Cap Dynamic Machine Pvt. Ltd. 1 6000 Ltr.
b) 3500 Ltr. Cap Dynamic Machine Pvt. Ltd. 1 3500 Ltr.
c) 3000 Ltr. Cap Dynamic Machine Pvt. Ltd. 1 3000 Ltr.
d) 1000 Ltr. Cap Dynamic Machine Pvt. Ltd. 1 1000 Ltr.
e) 300 Ltr. Cap Dynamic Machine Pvt. Ltd. 1 300 Ltr.
f) 100 Ltr. Cap Dynamic Machine Pvt. Ltd. 1 100 Ltr.
g) 200 Ltr. Cap Dynamic Machine Pvt. Ltd. 1 200 Ltr.
h) 1500 Ltr. Cap Dynamic Machine Pvt. Ltd. 1 1500 Ltr.
2. Portable Stirrer Dynamic Machine Pvt. Ltd 1 ---
3. Stirrer Dynamic Machine Pvt. Ltd 2 ---
4. Filter Press Magumps Pvt.Ltd. 1 6000 Ltr.
5. Colloid Mill Cadmach 1 6000 Ltr.
6. Transfer Pumps Dynamic Machine Pvt. Ltd 1 6000 Ltr.
7. Bottle Washing Machine Dynamic Machine Pvt. Ltd 1 36000
bottles/hr
8. Six Head Bottle Filling Dynamic Machine Pvt. Ltd 1 30000
Machine bottles
9. Two Head Liquid Filling Dynamic Machine Pvt. Ltd 1 30000
Machine bottles
10. Semi Auto Sealing Dynamic Machine Pvt. Ltd 1 3000
Machine (Crown Cap) bottles
11. Automatic Sealing Automat 1 40000
Machine bottles
12. Inspection Hood Dynamic Machine Pvt. Ltd 2 ---
13. Ambica Labeling AMBICKA 1 40000
Machine bottles
14. Carry Strap Machine NOBEL 2 1200 boxes

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Concept Pharmaceuticals Ltd Report of In-Plant Training

MAJOR MACHINERY AVAILABLE IN MANUFACTURING


OF OINTMENT DEPARTMENT

SL. Name Of Equipment Name Of the Mfgr. Qty. Capacity


No.
1. S.S. Jacketed Pan with Dynamic Machine Pvt. Ltd. 1 250 kg
Planetary Type Mixing
arrangement & built in
homogenizing
arrangements
2. Automatic Ointment Prechitech Bombay 1 1200 tubes
Filling Machine (Tube)
3. Mixing & Storage Tank Dynamic Machine Pvt. Ltd. 2 200 kg
4. Crimping Machine Dynamic Machine Pvt. Ltd. 1 ---
5. Vacuum Cleaning Machine Dynamic Machine Pvt. Ltd. 1 ---
6. Electronic Balance ATCO MAKE 1 500 gm

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Concept Pharmaceuticals Ltd Report of In-Plant Training

MAJOR MACHINERY AVAILABLE IN


MANUFACTURING OF INJECTION DEPARTMENT
SL. Name of Equipment Name of the Mfgr. Qty. Capacity
No.
1. Hot Air Sterilizer Dynamic Machine Pvt. Ltd. 1 ---

2. Dry Heat Sterilizer Dynamic Machine Pvt. Ltd. 1 ---

3. Steam Sterilizer Lance Engineers Co. 1 ---

4. Ampoule/Washing Dynamic Machine Pvt. Ltd. 1 80/min


Machine

5. Distilled Water Unit Lance Engineers Co. 1 150/Ltr.hr.

6. a) Vial Washing Machine P.S.E 1 80 vial/min


b) Vial Washing Machine Harsiddhi 1 80 vial/min

7. Bung Washing Machine Excel 2 7000/hr

8. Pressure Vessels
a) 200 Ltr. Capacity Dynamic Machine Pvt. Ltd. 1 ---
b) 100 Ltr. Capacity Dynamic Machine Pvt. Ltd. 2 ---
c) 20 Ltr. Capacity Dynamic Machine Pvt. Ltd. 1 ---
d) 5 Ltr. Capacity Dynamic Machine Pvt. Ltd. 1 ---

9. Pressure Vessels
a) 200 Ltr. Capacity United Engineers Ltd. 2 ---
b) 50 Ltr. Capacity United Engineers Ltd. 2 ---
c) 20 Ltr. Capacity United Engineers Ltd. 2 ---

10. Two Head Vial Filling Dynamic Machine Pvt. Ltd. 1 40 vial/min
Machine

11. Ampoule Filling & United Engineers Ltd. 1 52ampoule/min


Sealing Machine

12. 50 Ltr. SS Cans ---- 5 ---

13. 20 Ltr. Glass Corboy ---- 2 ---

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Concept Pharmaceuticals Ltd Report of In-Plant Training

14. 25 Ltr. Pressure Vessels ---- 2 ---

15. Vial Cap Sealing Machine United Engineers Ltd. 2 40 vial/min

16. Liquid Filling Machine Excel 1 80 vial/min


Double Stroke

17. Vial/Ampoule Labeling Dynamic Machine Pvt. Ltd. 1 40 vial/min


Machine

18. Dry Powder Filling AMBA Engg. Co. 1 40 vial/min


Machine

19. Amber Volumetric AMBA Engg. Co. 1 80 vial/min


Powder Filling Machine

20. Vial Labeling Machine AMBA Engg. Co. 1 120 vial/min

21. Plugging Machine Excel 1 80 vial/min

22. Aluminium Cap Sealing Excel 1 120 vial/min


Machine
1 80 vial/min
23. Rubber Plugging Machine Excel

24. Aluminium Sealing Balaji 1 120 vials/min


Machine

25. Double Cone Blender United Engg 1 8 kg/hr.


(10kg)

26. Split A/c Voltas. 1 ---

27. Air Module Klenzider 1 ---

28. a) Laminar Air Flow Kirloskar 2 ---


b) Laminar Air Flow Air Pack 2 ---
c) Laminar Air Flow Klanzider 2 ---

29. Clean Air Bench Kirloskar 1 ---

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Concept Pharmaceuticals Ltd Report of In-Plant Training

30. Pressure Vessels Kumar Process Engg. 1 400 Ltr.

31. S.S. Candel Filter Kumar Process Engg. 1 ---

32. Filter Press Unit Unit Pack 1 ---

33. Inspection Hood Dynamic Machine Pvt. Ltd. 1 ---

34. Air Handling Unit Volts 1 ---

35. Vacuum Pumps ACME VAC 1 ---

36. Refrigerators Kelvinator 1 165 Ltr.

37. Bubble Point Apparatus Dynamic Machine Pvt. Ltd. 1 ---

38. Leak Test Apparatus Dynamic Machine Pvt. Ltd. 1 ---

39. Oven Dynamic Machine Pvt. Ltd. 1 ---

40. Dehumidifier Tropical 1 ---

41. Membrane Holder Pharma Lab. 3 ---

42. Electronic Blance Mettler 1 300 gm

43. Inspection Powder AMBA Engg. 1 90 vials/min


Machine

44. Bung Dryer United 1 15000

45. S.S. Trays Vial Pharma Electro 770 180 vials/tray

46. S.S. Trays Ampoules Pharma Electro 130 350 vails/tray

47. Membrane Holder Pharma Lab. 1 ---

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Concept Pharmaceuticals Ltd Report of In-Plant Training

SOURCES OF HEAT ENERGY

Boilers are used as the source of heat energy.

Capacity ---------- 1.5 tons

Fuel used ---------- furnace oil

The hard water from the local source is treated in ion exchange resin to remove
the hardness of the water & make soft water(5ppm).

Using the steam generator at high pressure of 10 kg at a temperature of 200 Deg.


Cent. This water is heated & is transferred to the production area with a pressure of 5 kg
& temperature of 150 Deg. Cent.

SOURCES OF ELECTRICITY

MSEB ( Maharashtra State Electricity Board ) is the source of electricity.

The power requirement is 500 KAV.

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Concept Pharmaceuticals Ltd Report of In-Plant Training

SOURCES OF WATER

The local source of water is MIDC ( Maharashtra Industrial Development


Corporation).

The water is treated before it is used in the industry.

FLOW CHART SHOWING THE TREATMENT OF THE WATER:

MIDC Water

Water Treatment Plant ( Chlorination )

Dematerialized Water -------U.V. Unit -----Non-parental Use

Distillation

Parental Use

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Concept Pharmaceuticals Ltd Report of In-Plant Training

EFFLUENT AND TREATMENT

The liquid effluents in the industry are being treated.

STEP –1: At first the liquid is treated in the oil separators. This is to separate the oil
contents in the liquid.

STEP – 2: This is passed to a tank where air bubbling is performed. Here the effluent
gases are removed from the water. This degassing is done up to 2 hours or more
depending upon the effluent gas present in the liquid.

STEP – 3: The process may not degas all the effluent gases present in the liquid. For
this the liquid is again passed through the aerator. The aerator pumps the air in a high
pressure to make a fountain of droplets of water. This will help to remove every trace of
dissolved gases.

STEP –4: The liquid mostly may be of altered pH. According to the type of the effluent
liquid it may be treated with either acid or alkali to bring the liquid to normal pH of 7.

STEP – 5: The treated water is efficiently reused for irrigation in gardens & lawns of
the company.

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Concept Pharmaceuticals Ltd Report of In-Plant Training

MAJOR MACHINERY AVAILABLE IN


MANUFACTURING OF UTILITY DEPARTMENT

SL. Name Of Equipment Name of the Mfgr. Qty. Capacity


No.

1. Steam Boiler Steamslar 1 1.5 mt/hr


2. Steam Boiler Elight 1 600 kg/hr
3. Air Compression Kirloskar 1 100 CFM
7
kg/sq.cm
4. D.G. Set with Control Ashok Leyland 1 62.5
Panel KVA
5. D.M. Water Plant Ion-Exchange 1 10 Cub.
Mtr./Reg
eneration

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Concept Pharmaceuticals Ltd Report of In-Plant Training

PURCHASE DEPARTMENT

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Concept Pharmaceuticals Ltd Report of In-Plant Training

SOURCE OF RAW MATERIALS


There are all three types of sources:

 Local

 Indigenous

 Imported

SUPPLIERS LIST:

Examples of some of the sources:

1. NOSCH Labs Pvt. Ltd Hyderabad


2. JAIN Acid & Chemicals Aurangabad
3. Alkyl amines chemicals Ltd. Pune
4. J.B. KHOKHANI & CO Mumbai
5. EBERS PHARMA Mumbai
6. CRYSTAL PHARMA Mumbai
7. GUJARAT Organic Ltd. Gujarat
8. UNIVERSAL CAPSULES Pvt. Ltd. Thane
9. AQUATIC REMEDIES Ahmedabad
10. SANTOSH Ayurvedic Drug Supply Mumbai

SOME IMPORT SOURCES:

a) NOVEON JNC U.S.A

b) FEI CHING RUITAI China

c) FEI CHING China

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Concept Pharmaceuticals Ltd Report of In-Plant Training

Materials Management

The Materials Management applications must provide the NCAS with capabilities
for managing and controlling the State's purchasing and accounts payable policies and
accounting for the inventoried assets.

The Materials Management modules are currently integrated components of the


NCAS with the exception of the Fixed Assets Module (FA). The following paragraphs by
business application, portray the fully integrated process.

Overview of Current Materials Management Process

Through shared vendor and policy information, Purchasing and Accounts Payable
functions can freely communicate without the usual control issues associated with
duplication of files and batch interfaces. Accounts Payable shares purchase order
information from Purchasing and updates the invoiced-to-date amount on the purchase
order real-time. Receipts are entered and referenced to a purchase order number,
ensuring accurate posting of deliveries to each purchase order line. Receipts that cannot
be identified or that do not fit matching criteria are identified, placed on hold, and
reported for buyer action. Each receipt is checked for proper delivery points and verified
that the quantities received and the receipt date are within tolerances already defined on
the purchase order. Another receipt requirement, inspection of goods, is handled through
dock-to-stock tracking. This feature tracks the inspection of materials according to a
table of routing and inspection areas.

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Concept Pharmaceuticals Ltd Report of In-Plant Training

Accounts Payable performs the invoice audit and approval functions by checking
invoice details such as amounts, unit price, terms, tax, freight, etc. against the purchase
order. Data entry effort is minimal, because invoice details are built from the purchase
order and displayed on-line. Accounts payable clerks have to deal only with the
exceptions, resulting in maximum efficiency with full control. The NCAS system uses a
PC-based, laser printing process to support the creation of vendor payments. The laser
check printing process has strong internal controls, including password protection access
to the check printing software, the use of security chips in the printers themselves, as well
as the use of blank check stock (vs. pre-printed check forms). Agencies print checks
locally, using a nightly check file that is downloaded from the NCAS mainframe system.

The Inventory integration with the Purchasing system is designed to address


warehouse replenishment needs. Information about stock items and requisitions for
replenishment are passed from Inventory to Purchasing, and purchase orders and receipts
pass from Purchasing to Inventory. The following information is shared between the two
systems: items, requisitions, purchase orders, and receipts.

Requisitions are created to replenish warehouse inventory. They can be generated


either automatically in batch by the system, or created manually by the inventory
replenishment planner. Once approved, these requisitions automatically pass to
Purchasing to be converted into purchase orders. When goods are received in the
Purchasing function, the quantity is passed to Inventory to reduce the on-order quantity
and increase the on-hand quantity. If goods undergo inspection in the Purchasing
function, the active on-hand quantity is not increased in the Inventory until the goods
have passed inspection.

The Materials Management systems maintain accounting integrity through


integration with the General Ledger. Distribution entries from purchase orders, Accounts
Payable and Inventory issues and replenishments are validated directly against the
General Ledger. Offsetting cash, assets accounts, and encumbrances are automated
through the accounting rules or system policies to ensure accounting accuracy.

The integration of the Materials Management functions with the budgetary control
function provides the funds-checking capability required for the NCAS. All Purchasing,
Accounts Payable, and Inventory transactions (commitments, encumbrances, inventory
consumption and replenishment, and expenditures) are checked real-time to the available
funds amount calculated through budgetary control functions. Real-time funds checking
ensures expenditures are kept within the authorized budget and provides advanced
knowledge of the budgetary status for spending decisions.

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Concept Pharmaceuticals Ltd Report of In-Plant Training

Purchasing

The Purchasing function is a real-time, decision support application designed to


help manage the entire procurement cycle. This cycle includes requesting, competitive
bidding, buying, receiving, and inspecting. Purchasing agents' day-to-day decision-
making is fully supported with tools and information on-line to manage the supplier base
and service the purchasing function for the State in a timely and efficient manner.
Figures 6 and 7 display the participants and tasks in the Purchasing or Competitive
Sourcing and Vendor Selection processes, respectively.

Purchasing Financial Functions

The State's purchasing policies and strategies are the basis for the system and are
incorporated into a policy hierarchy. The policy hierarchy consists of rules that define
how to handle purchasing functions within the government environment. The most
general purchasing policies represent the highest level of the hierarchy, and each
successive level below the general policy defines further levels of detail to the general
policy.

As requisitions and purchase orders are processed, the policy hierarchy ensures
that the majority of the purchasing activity is handled automatically and within the
required purchasing guidelines. If a particular situation does not fit the general rules, a
purchaser may change the hierarchy default to fit the situation; however, the system
tracks in detail the full procurement process from requisition to payment.

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Concept Pharmaceuticals Ltd Report of In-Plant Training

Overview of Current Purchasing Process

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Concept Pharmaceuticals Ltd Report of In-Plant Training

The Purchasing function provides:

 Full integration with Accounts Payable, Inventory, Budgetary Control, and


General Ledger;
 Real-time encumbering of funds and confirmation of funds availability;
 A centrally-controlled item file that ensures a consistent statewide purchasing
history database;
 Common policy files for Purchasing and Accounts Payable;
 A statewide central vendor file that is shared by both Purchasing and Accounts
Payable;
 Funds checking at each decision point (requisition, purchase order, and Accounts
Payable);
 Buyer tools (on-line buyer split requisition worksheet);

Purchasing Reporting Functions

Reporting within the Purchasing function supports:

 Daily purchasing decisions through buyer action reports and buyer exception
reports, and
 Central management requirements for the Division of Purchase and Contract
(P&C) HUB reporting and recycled goods reporting.

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Concept Pharmaceuticals Ltd Report of In-Plant Training

QUALITY CONTROL
DEPARTMENT

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Concept Pharmaceuticals Ltd Report of In-Plant Training

QUALITY CONTROL
Quality control can be broadly defined as the day to day control of quality within
the company, a department staffed with scientists & technicians responsible for the
acceptance or rejection of incoming raw materials & packing components for the myriad
of in-process tests & inspection to assure that systems are being controlled & monitored
& finally for the approval or rejection of completed dosage forms.

OBJECTIVE:

 Evaluation of raw material

 In-process Testing

 Finished Product Testing

 Packing Material Testing

 Microbial Test

SYSTEMS ADOPTED IN QUALITY MAINTENANCE:

 All steps in production & packing are initiated only after the approval of the Q.A
department
 Every raw material, which enters the company, is tested foe purity. In other words
100% sampling is effected. This ensures that on low quality material enter the
production set up.
 In=process quality control Pharmacoepia limits.

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Concept Pharmaceuticals Ltd Report of In-Plant Training

IN-PROCESS QUALITY CONTROL TESTS:

 TEST FOR RAW MATERIALS: Identification, Loss on drying, Heavy metals,


Sulphated ash & Assay.

 TEST FOR GRANULES: Bulk density, Moisture content & Assay.

 TEST FOR TABLETS: Weight variation, Disintegration time, Dissolution,


Friability & Assay.

 UNOFFICIAL TESTS: Hardness & Thickness.

ORGANIZATION CHART OF QUALITY CONTROL:

Deputy General Manager

Manager

2 Executive Officers

3 Officers

4 Chemists

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Concept Pharmaceuticals Ltd Report of In-Plant Training

INSTRUMENTS USED IN QUALITY CONTROL


DEPARTMENT
SL. INSTRUMENT MODEL No. MANUFACTURER
No.
1. Sonicator 300w DUEX Instruments
2. Automatic Titrator AT-38 Spectra Lab
3. Weighing Blances-2 AE 160 Mettler
4. Tablet Dissolution Test Apparatus DA-6D V Scientific
5. Digital pH meter PHAN Lab India pH
analyzer
6. Karl Fisher Apparatus AUTO-1 Globe Trotters Pvt.
Ltd.
7. Tapped Density Tester E.T-1020 Electrolab
8. Melting Point Apparatus ALM 310 Analink
9. Digital Conductivity Meter CIN-180 Elico Pvt. Ltd
10. Tablet friability Test Apparatus ALM 310 Veego Pvt. Ltd
11. Tablet hardness tester VDT Ketan
12. Tablet Disintegration Test apparatus VID-3 Veego Pvt. Ltd
13. Kompakt U.V Cabinet ---- Kompakt Pvt. Ltd
14. Antibiotic Zone Reader ---- Tab-Machines
15. Microscope ---- Labo Pvt. Ltd
16. Gradvel Laminar Flow 1103 Klenzaids
17. Drying Oven ---- Shivani Scientific
Industry (p) Ltd
18. Heating Mantle-3 UMA 59 Subhadra scientific
& Surgicals
19. Laboratory Oven for Drying ---- ACE Techno
20. Research Centrifuge TC 4100d Eltec Pvt. Ltd
21. U.V Spectrophotometer U.V1700 Shimadzu
22. Polarimeter 341 Parkin Elmer
23. F.T.I.R RX 1 FT-IT Parkin Elmer
24. Gas chromatograph OMEGA VIR Netel
Chromatographs
25. Potassium Bromide Press ---- Spectra Lab
26. H.P.L.C 875 Jasco
U.V/VIS
Detector & 880 PU
Pump
27. H.P.L.C 1100 Agilents

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Concept Pharmaceuticals Ltd Report of In-Plant Training

QUALITY ASSURANCE
DEPARTMENT

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Concept Pharmaceuticals Ltd Report of In-Plant Training

QUALITY ASSURANCE
Quality assurance may be defined as the responsibility of an organization to
determine the systems-facilities that system-facilities & written procedures are both
adequate & followed in order to assure that products are controlled & will meet the final
dosage forms, all the applicable specifications.

Quality assurance naturally then becomes an over site function, often auditing to
determine that procedures & systems are suitable & if not, to recommend the required
changes.

ORGANIZATION CHART OF Q.A

General Manager

Officers

Supervisor

Chemist

Quality assurance involves the activity of providing evidence, much needed to


establish confidence among all those concerned, that the quality function being followed
taken care of.

Quality assurance provides protection against quality related problems. The


responsibility of Q.A department is to control & assure the right quality of raw materials,
packing materials & the finished products is maintained all along.

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Concept Pharmaceuticals Ltd Report of In-Plant Training

INPROCESS INSPECTION

Objective

In the concept of Quality Assurance, quality has to be built in throughout the process &
not to be Checked /Controlled at final stage of Process i.e. finished product. In the
process of building up of the quality, in-process inspection had major role. The in-process
inspections serve to have checks at different stage of the manufacturing process, which
ultimately controls the quality of the product.

Responsibility : Quality Assurance Inspector


Chemist/Officer Quality Assurance is responsible to perform the activity as per
procedure. They are directly reporting to Q.A.Manager

Head of Quality Assurance is responsible for effective implementation and training of


procedure.

Procedure
The persons are provided with check points for various operations & required to observed
the deviations from the specified operational norms & are required to immediately report
such deviations to the immediate person responsible for the operations & subsequently to
Q.A Head. In case the person is doubtful about his judgment, he is required to stop the
process as an immediate preventive action & then consult with senior for guidance in the
matter.

But in any case no operation, with any type of deviation is allowed to continue
unless the doubt/deviation is sorted out

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Concept Pharmaceuticals Ltd Report of In-Plant Training

Check point:-
General

At the time of starting of the operation, check for total removal of unwanted
material form the area. In case of other material is required to be stored in the area it
should have been well segregated & labeled.

Check the area for cleanliness & required environment conditions.

Check that the operation is being carried out by an experienced & authorized
operator.

Check that all personnel are wearing the required uniforms, nose masks, hand
gloves etc.

Check that all container stored in the area are labeled with full details viz.
Product, Batch No. Mfg., Exp. Date, Stage of operation.

Check that at a time, in a specified area & with the specified set of equipment,
only one batch processed, there is no spill over of the batches & batch identity is
maintained.

In case of any observed deviation ask the operator to discontinue the operation as
an immediate preventive measure & report the deviation to the person in-charge of
operation as well as to the Quality Assurance Head.

Physical parameters of in-process products are to be checked at the start of the


batch and at random during the processing of the batch to verify that all parameters are
within the prescribed limits .

Maintain the records of all the observations.

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Concept Pharmaceuticals Ltd Report of In-Plant Training

FINANCE DEPARTMENT

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Concept Pharmaceuticals Ltd Report of In-Plant Training

ACCOUNTING

Costing :

The department in question has an enormous impact on the overall performance


of any industry. The effectiveness or ineffectiveness of the costing department is quite
clear or obvious at the slightest glance on the performance or result of the industry.
Costing plays a major role as far as the yield of the industry goes. It plays a buffer role in
between the management and the various operation departments.

Costing department in industry is supposed to be of the most efficient and result


oriented department and is directly responsible for determining the margin of profit.
Costing department carries out various jobs such as,

 Determining the efficiency of the operations on which the incentive scheme is to


be formulated.

 Preparing the daily production report, monthly production report, monthly


performance report and so on.

 Record of the damages bottles which could be taken into A/C while preparing the
yearly A/C.

The most important function of the costing department is the provision of the
material requirement for various department to the stores.

Costing department has also taken up the job of evaluating the efficiency of every
single operation. Time study is done operationwise. For each operation with all the
necessary time for getting the material.

Costing department also records the receipts, issue of the costly or bulk
requirement raw materials. The costing department has its own record for opening
balance, issues during the month & receipts during the month. A physical inventory of
stock is carried out.

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The costing department records all the issues of raw material. A comparison of actual
issues as against budgeted or estimated quantity is made. Variances are found out and
necessary action are taken such as :

 The correction in cost cards is made this exercise is carried out at every month
end and various statement prepared.

 Costing department also maintain a record for wastage, destroyed, samples given
as gift which helps in preparing the final A/C.

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MARKETING DEPARTMENT

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“The soul of the mktg. is to deliver a higher std. Of quality”

Marketing Department Involves

Following Aspects :

1. Customer Demand & Sale Forecasting


2. Marketing Research & Information
3. Marketing Strategy / Planning
4. Advertising
5. Managing distribution channel
6. International Markets

Company Demand

Demand Market

Market (Industry demand) Company demand

Market Potential Market Forecast Company Sale Company Sale


Potential Forecast

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Company Sales Forecast

It is estimated sales turnover under a defined marketing program. The sales


forecast is the planned level of sales based upon a given marketing strategy.

Sales Forecast Procedure

Economic Forecast – Level & Trends

Industry Activity & Forecast

Company Demand Forecast

Sale Demand Forecast

Sale Forecast

Based on what people say Based on what people do

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Various marketing strategies and steps are followed by marketing dept of


Concept Pharmaceutical Ltd. This organization has a strong marketing unit with the help
of this organization made a strong image in domestic as well as foreign market .
Following is the plan & steps of company to be followed in marketing field.

How to write a Marketing Plan

A marketing plan is a written document that details the actions necessary to


achieve one or more marketing objectives. It can be for a product or service, a brand, or a
product line. It can cover one year (referred to as an annual marketing plan), or cover up
to 5 (sometimes referred to as five) years.

A marketing plan may be part of an overall business plan. Solid marketing


strategy is the foundation of a well-written marketing plan. While a marketing plan
contains a list of actions, a marketing plan without a sound strategic foundation is of little
use.

The Marketing Plan is generally undertaken for one of the following reasons :

 Needed as part of the yearly planning process within the marketing functional
area.

 Needed for a specialized strategy to introduce something new, such as new


product planning, entering new markets, or trying a new strategy to fix an existing
problem.

 Is a component within an overall business plan, such as a new business proposal


to the financial community.

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The marketing planning process

 Corporate mission
 Corporate vision
 Objectives for non-profit-making organizations
 Marketing audit
 Analysis
 Marketing objectives
 Emergent strategy
 Marketing strategies
 Detailed plans and programmes

Content of the marketing plan

 2.1 Small business


 2.2 Medium-sized and large organizations

Measurement of Progress

Performance analysis

 Sales analysis
 Market share analysis
 Expense analysis
 Financial Analysis
 Use of Marketing Plans

Budgets as Managerial Tools

 5.1 Approaches to budgeting

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The marketing planning process

In most organizations, "strategic planning" is an annual process, typically


covering just the year ahead. Occasionally, a few organizations may look at a practical
plan which stretches three or more years ahead.

To be most effective, the plan has to be formalized, usually in written form, as a


formal `marketing plan'. The essence of the process is that it moves from the general to
the specific; from the overall objectives of the organization down to the individual action
plan for a part of one marketing programme. It is also an iterative process, so that the
draft output of each stage is checked to see what impact it has on the earlier stages - and
is amended accordingly.

Corporate mission

Behind the corporate objectives, which in themselves offer the main context for
the marketing plan, will lie the 'corporate mission'; which in turn provides the context
for these corporate objectives. This `corporate mission' can be thought of as a definition
of what the organization is; of what it does: 'Our business is …'.

This definitions should not be too narrow, or it will constrict the development of
the organization; a too rigorous concentration on the view that `We are in the business of
making meat-scales', as IBM was during the early 1900s, might have limited its
subsequent development into other areas. On the other hand, it should not be too wide or
it will become meaningless; `We want to make a profit' is not too helpful in developing
specific plans.

Abell suggested that the definition should cover three dimensions: 'customer
groups' to be served, 'customer needs' to be served, and 'technologies' to be utilized.

Thus, the definition of IBM's `corporate mission' in the 1940s might well have
been: `We are in the business of handling accounting information [customer need] for the
larger US organizations [customer group] by means of punched cards [technology].'
Fortunately, as the name itself (International Business Machines) indicates, IBM already
had a wider perspective (and its corporate mission was virtually defined by its name).
Planning is the key element of the management function

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Corporate vision

Perhaps the most important factor in successful marketing is the `corporate


vision'. Surprisingly, it is largely neglected by marketing textbooks; although not by the
popular exponents of corporate strategy - indeed, it was perhaps the main theme of the
book by Peters and Waterman, in the form of their `Superordinate Goals'. [2] Theodore
Levitt said: "Nothing drives progress like the imagination. The idea precedes the deed.

If the organization in general, and its chief executive in particular, has a strong
vision of where its future lies, then there is a good chance that the organization will
achieve a strong position in its markets (and attain that future). This will be not least
because its strategies will be consistent; and will be supported by its staff at all levels. In
this context, all of IBM's marketing activities were underpinned by its philosophy of
`customer service'; a vision originally promoted by the charismatic Watson dynasty.

Henry Mintzberg explained: "... in some cases, in addition to the mission there is
the `sense of mission', that is, a feeling that the group has banded together to create
something new and exciting. This is common in new organizations".

What a worthwhile vision consists of is, however, usually open to debate; hence
the reason why such visions tend to be associated with strong, charismatic leaders. But
the vision must be relevant. The message for the marketer is that, to be most effective, the
marketing strategies must be converted into a powerful long-term vision; if such a vision
does not already exist.

Objectives for non-profit-making organizations

In the case of non-profit organizations the objectives may be less than clear. Keith
Blois suggested five main reasons for the differences from `commercial' organizations:

 Ambiguous Goals [more actors and groups of actors are involved]


 Lack of Agreement in Means-End Relationships [even where there is consensus
on the goal there may be disagreement on how to get there]
 Environmental Turbulence [non-profit organizations seem to be exposed more to
turbulence than commercial ones]
 Unmeasurable Outputs [unfortunately, by definition, non-profit organizations do
not have the classically convenient simplicity of `bottom-line profit']
 The Effects of Management Intervention are Unknown [the lack of precision
caused by factors 1-4 is problem enough, but the `culture' seems to add further
barriers to managing these organizations]

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Even so, Kotler and Andreasen suggested some possible objectives for such
organizations:

 Surplus Maximization [equivalent to profit maximization]


 Revenue Maximization [as for profit-making organizations]
 Usage Maximization [maximizing the numbers of users and their usage]
 Usage Targeting [matching the capacity available]
 Full Cost Recovery [breaking even]
 Partial Cost Recovery [minimizing the subsidy]
 Budget Maximization [maximizing what is offered]
 Producer Satisfaction Maximization [satisfying the wants of staff]

Marketing audit

The first formal step in the marketing planning process is that of conducting the
marketing audit. Ideally, at the time of producing the marketing plan, this should only
involve bringing together the source material which has already been collected
throughout the year - as part of the normal work of the marketing department.

The emphasis at this stage is on obtaining a complete and accurate picture. In a


single organization, however, it is likely that only a few aspects will be sufficiently
important to have any significant impact on the marketing plan; but all may need to be
reviewed to determine just which 'are' the few.

In this context some factors related to the customer, which should be included in
the material collected for the audit, may be:

 Who are the customers?


 What are their key characteristics?
 What differentiates them from other members of the population?
 What are their needs and wants?
 What do they expect the `product' to do?
 What are their special requirements and perceptions?
 What do they think of the organization and its products or services?
 What are their attitudes?
 What are their buying intentions?

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A `traditional' - albeit product-based - format for a `brand reference book' (or,


indeed, a `marketing facts book') was suggested by Godley more than three decades ago:

Financial data --Facts for this section will come from management accounting, costing
and finance sections.

Product data --From production, research and development.

Sales and distribution data - Sales, packaging, distribution sections.

Advertising, sales promotion, merchandising data - Information from these


departments.

Market data and miscellany - From market research, who would in most cases act as a
source for this information.

This sources of data, however, assume the resources of a very large organization.
In most organizations they would be obtained from a much smaller set of people (and not
a few of them would be generated by the marketing manager alone). It is apparent that a
marketing audit can be a complex process, but the aim is simple: 'it is only to identify
those existing (external and internal) factors which will have a significant impact on the
future plans of the company'.

It is clear that the basic material to be input to the marketing audit should be
comprehensive. Accordingly, the best approach is to accumulate this material
continuously, as and when it becomes available; since this avoids the otherwise heavy
workload involved in collecting it as part of the regular, typically annual, planning
process itself - when time is usually at a premium. Even so, the first task of this `annual'
process should be to check that the material held in the current `facts book' or `facts files'
actually 'is' comprehensive and accurate, and can form a sound basis for the marketing
audit itself.

The structure of the facts book will be designed to match the specific needs of the
organization, but one simple format - suggested by Malcolm McDonald - may be
applicable in many cases. This splits the material into three groups:

'Review of the marketing environment'. A study of the organization's markets,


customers, competitors and the overall economic, political, cultural and technical
environment; covering developing trends, as well as the current situation.

'Review of the detailed marketing activity'. A study of the company's marketing


mix; in terms of the 4 Ps - product, price, promotion and place.

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'Review of the marketing system'. A study of the marketing organization,


marketing research systems and the current marketing objectives and strategies.

The last of these is too frequently ignored. The marketing system itself needs to be
regularly questioned, because the validity of the whole marketing plan is reliant upon the
accuracy of the input from this system, and `garbage in, garbage out' applies with a
vengeance.

Analysis

The analysis of this material will, no doubt, require significant effort. In the first
instance it is a matter of selection, of sorting the wheat from the chaff. What is important,
and will need to be taken into account in the marketing plan that will eventually emerge
from the overall process, will be different for each product or service in each situation.
One of the most important skills to be learned in marketing is that of being able to
concentrate on just what is important.

It is important to say not just what happened but why. The process of marketing
planning encompasses all of the marketing skills. However, a number of these may be
particularly relevant at this stage:

 'Positioning'. The starting point of the marketing plan must be the consumer. It is
a matter of definition that his or her needs should drive the whole marketing
process. The techniques of positioning and segmentation therefore usually offer
the best starting point for what has to be achieved by the whole planning process.

 'Portfolio planning'. In addition, the coordinated planning of the individual


products and services can contribute towards the balanced portfolio.

 '80:20 rule'. To achieve the maximum impact, the marketing plan must be clear,
concise and simple. It needs to concentrate on the 20 per cent of products or
services, and on the 20 per cent of customers, which will account for 80 per cent
of the volume and 80 per cent of the `profit'.

 '4 Ps': Product, Place, Price and Promotion. The 4 Ps can sometimes divert
attention from the customer, but the framework they offer can be very useful in
building the action plans.

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Marketing objectives

It is only at this stage (of deciding the marketing objectives) that the active part of
the marketing planning process begins'.

This next stage in marketing planning is indeed the key to the whole marketing
process. The marketing objectives state just where the company intends to be; at some
specific time in the future. James Quinn succinctly defined objectives in general as:
"Goals (or objectives) state 'what' is to be achieved and 'when' results are to be
accomplished, but they do not state 'how' the results are to be achieved".

They typically relate to what products (or services) will be where in what markets
(and must be realistically based on customer behaviour in those markets). They are
essentially about the match between those 'products' and 'markets'. Objectives for pricing,
distribution, advertising and so on are at a lower level, and should not be confused with
marketing objectives. They are part of the marketing strategy needed to achieve
marketing objectives.

To be most effective, objectives should be capable of measurement and therefore


'quantifiable'. This measurement may be in terms of sales volume, money value, market
share, percentage penetration of distribution outlets and so on. An example of such a
measurable marketing objective might be `to enter the market with product Y and capture
10 per cent of the market by value within one year'. As it is quantified it can, within
limits, be unequivocally monitored; and corrective action taken as necessary.

The marketing objectives must usually be based, above all, on the organization's
financial objectives; converting these financial measurements into the related marketing
measurements.

In marketing, objectives are often built using the SMART acronym.

It is conventionally assumed that marketing objectives will be designed to


maximize volume or profit (or to optimize the utilization of resources in the non-profit
sector), by creating demand or rejuvenating existing demand, say; although the various
sub-objectives may indicate many different routes to achieving such optimization.

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However, as Kotler suggested (in the earlier edition of his book), there may be a
number of other objectives:

 Synchromarketing

 Demarketing

 Counter-marketing

Synchromarketing - The aim may be to `redistribute' existing sales (which are already at
optimum levels) so that they occur at times, or in places, which the supplier prefers.
Thus, for example, organizations which have highly seasonal sales (which make
inefficient use of resources) may want to increase non-seasonal sales. Walls achieved this
by balancing its summer sales of ice-cream with pies and sausages, demand for which
peaks in winter. The suppliers of central-heating oil offer special deals for those
customers willing to restock their tanks in summer.

Demarketing' - Demand may sometimes exceed supply. In these circumstances the


emphasis will be on rationing scarce supplies. Occasionally the supplier, rather than bring
on-stream expensive new plant, may seek to persuade customers to buy less (or be less
dissatisfied with the scarcity). Some suppliers of electrical energy (electricity generators
in Europe and the USA) have heavily advertised energy conservation measures to achieve
this end (otherwise, the cost of meeting the peak winter loads would be very high - and
unprofitable).

Counter-marketing - In what is usually a public-sector activity (but is occasionally


undertaken by the private sector, where some uses of a product are damaging the
corporate image), there may be an objective of stopping consumption completely. The
anti-tobacco and anti-drug campaigns are the most obvious examples; but McDonald's
campaigns to stop its customers dropping litter, or the brewers' campaigns to stop
drinking and driving, fall into this category.

Emergent strategy

In this case, the intended strategy, decided upon traditionally or incrementally, is


overtaken by events in two main ways. One, which will probably be recognized by the
organization, is that of unrealized strategy; where it proves impossible to implement the
chosen strategy in practice.

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Less obvious is the emergent strategy which is decided by events in the external
environment; and, thus, forced upon the organization. This may not necessarily be
recognized, in its totality, by the organization - since many of its implications may be
hidden. As markets become more complex, however, such emergent strategies are
becoming more common.

Many organizations see both these processes in terms of failure - they have been
forced, usually by unpredictable events, to abandon their own strategy. There is,
accordingly, a tendency for these unwelcome facts to be ignored until they are so obvious
that they cannot be avoided. This is a major error. Such deviations must be recognised
(probably through one or other form of environmental analysis coupled with networking)
as soon as possible- so that the organization can react in good time.

A much more powerful approach is, though, to be proactive; so seize upon these
deviations as the basis for future developments. What needs to be recognized is that
emergent strategies are the most powerful of all. They must, by definition, be directly
derived from the needs of the market - where even successful deliberate strategies may
not ideally match market needs but may achieve their targets by sheer force (especially
where conviction marketing lies behind them). Emergent strategies are, thus, likely to be
vigorous ones.

There are two main approaches to capitalizing on such emergent strategies. The
first of these, favored in the West, is the umbrella strategy. This is a form of very
positive delegation, in that the overall strategies, the umbrella, are very general in nature -
and allow the lower level managers, who are closest to the external environment, the
freedom to react to these changes.

A much more direct, and hence even more powerful, approach is that favored by
the Japanese corporations. They integrate emergent strategies with their own. Indeed it is
arguable that, in terms of marketing, to a large extent they use emergent strategies instead
of their own deliberate strategies. This is evidenced as much by an attitude of mind as by
any other feature. They deliberately go out to look for symptoms of such emergent trends
which can be detected in the performance of their own products. More than that, though,
they often deliberately launch a range of products rather than a single one to see which is
most successful. It is almost as if they deliberately seek out the emergent strategies by
offering the best environment for them to develop - the very reverse of the Western
approach which seeks to avoid them. The Japanese then go on to build on these emergent
strategies with a number of very effective tools - most of which are designed to overcome
the major problem which accompanies emergent strategies, that they emerge on the scene
much later than deliberate ones (and are likely to be visible to all the competitors at the
same time) so that time is the essence.

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Thus, time management techniques (including parallel development along with


flexible manufacturing and JIT) which have been developed by the Japanese offer them a
significant competitive advantage in handling such emergent strategies.

Marketing strategies

There are numerous definitions of what strategy is, but again James Quinn gave a
succinct general definition: "A strategy is a 'pattern' or 'plan' that 'integrates' an
organization's 'major' goals, policies and action sequences into a 'cohesive' whole" [7]
He went on to explain his view of the role of `policies', with which strategy is most often
confused: "Policies are rules or guidelines that express the 'limits' within which action
should occur.

Simplifying somewhat, marketing strategies can be seen as the means, or `game


plan', by which marketing objectives will be achieved and, in the framework that we have
chosen to use, are generally concerned with the 4 Ps. Examples are:

PRODUCT

 Developing new products, repositioning or relaunching existing ones and


scrapping old ones
 Adding new features and benefits
 Balancing product portfolios
 Changing the design or packaging

PRICE

 Setting the price to skim or to penetrate


 Pricing for different market segments
 Deciding how to meet competitive pricing

PROMOTION

 Specifying the advertising platform and media


 Deciding the public relations brief
 Organizing the salesforce to cover new products and services or markets

PLACE

 Choosing the channels


 Deciding levels of customer service

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In principle, these strategies describe how the objectives will be achieved. The 4
Ps are a useful framework for deciding how the company's resources will be manipulated
(strategically) to achieve the objectives. It should be noted, however, that they are not the
only framework, and may divert attention from the real issues. The focus of the strategies
must be the objectives to be achieved - not the process of planning itself. Only if it fits
the needs of these objectives should you choose, as we have done, to use the framework
of the 4 Ps.

The strategy statement can take the form of a purely verbal description of the
strategic options which have been chosen. Alternatively, and perhaps more positively, it
might include a structured list of the major options chosen.

One aspect of strategy which is often overlooked is that of 'timing'. Exactly when
it is the best time for each element of the strategy to be implemented is often critical.
Taking the right action at the wrong time can sometimes be almost as bad as taking the
wrong action at the right time. Timing is, therefore, an essential part of any plan; and
should normally appear as a schedule of planned activities.

Having completed this crucial stage of the planning process, you will need to re-
check the feasibility of your objectives and strategies in terms of the market share, sales,
costs, profits and so on which these demand in practice. As in the rest of the marketing
discipline, you will need to employ judgement, experience, market research or anything
else which helps you to look at your conclusions from all possible angles.

Detailed plans and programmes

At this stage, you will need to develop your overall marketing strategies into
detailed plans and programmes. Although these detailed plans may cover each of the 4
Ps, the focus will vary, depending upon your organization's specific strategies. A product-
oriented company will focus its plans for the 4 Ps around each of its products. A market
or geographically oriented company will concentrate on each market or geographical
area. Each will base its plans upon the detailed needs of its customers, and on the
strategies chosen to satisfy these needs.

Again, the most important element is, indeed, that of the detailed plans; which
spell out exactly what programmes and individual activities will take place over the
period of the plan (usually over the next year). Without these specified - and preferably
quantified - activities the plan cannot be monitored, even in terms of success in meeting
its objectives.

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It is these programmes and activities which will then constitute the `marketing' of
the organization over the period. As a result, these detailed marketing programmes are
the most important, practical outcome of the whole planning process. These plans should
therefore be:

 Clear - They should be an unambiguous statement of 'exactly' what is to be done.

 Quantified - The predicted outcome of each activity should be, as far as possible,
quantified; so that its performance can be monitored.

 Focused - The temptation to proliferate activities beyond the numbers which can
be realistically controlled should be avoided. The 80:20 Rule applies in this
context too.

 Realistic - They should be achievable.

 Agreed - Those who are to implement them should be committed to them, and
agree that they are achievable.

The resulting plans should become a working document which will guide the
campaigns taking place throughout the organization over the period of the plan. If the
marketing plan is to work, every exception to it (throughout the year) must be questioned;
and the lessons learned, to be incorporated in the next year's plan.

Content of the marketing plan


Small business
A marketing plan for a small U.S. business typically includes

 Demographics of customers
 Description of competitors, including the level of demand for the product or
service and the strengths and weaknesses of competitors
 Description of the product or service, including special features
 Marketing budget, including the advertising and promotional plan
 Description of the business location, including advantages and disadvantages for
marketing
 Pricing strategy
 Market Segmentation

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Medium-sized and large organizations

The main contents of a marketing plan are:

 Executive Summary
 Situational Analysis
 Opportunities / Issue Analysis - SWOT Analysis
 Objectives
 Strategy
 Action Programme (the operational marketing plan itself for the period under
review)
 Financial Forecast
 Controls

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IN DETAIL, A COMPLETE MARKETING PLAN


TYPICALLY INCLUDES:
 Title page

 Executive Summary

 Current Situation - Macroenvironment

 Economy
 Legal
 Government
 Technology
 Ecological
 Sociocultural
 Supply chain

 Current Situation - Market Analysis

 Market definition
 Market size
 Market segmnetation
 Industry structure and strategic groupings
 Porter 5 forces analysis
 Competition and market share
 Competitors’ strengths and weaknesses
 Market trends

 Current Situation - Consumer Analysis

 Nature of the buying decision


 Participants
 Demorgraphics
 Psychographics
 Buyer motivation and expectations
 Loyalty segments

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 Current Situation - Internal

 Company resources

o Financial
o People
o Time
o Skills

 Objectives

o Mission statement and vision statement


o Corporate objectives
o Financial objective
o Marketing objectives
o Long term objectives
o Description of the basic business philosophy

 Corporate Culture

 Summary of Situation Analysis

 External threats
 External opportunities
 Internal strengths
 Internal weaknesses
 Critical success factors in the industry
 Our sustainable competitive advantage

 Marketing research

 Information requirements
 Research methodology
 Research results

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 Marketing Strategy - Product

 Product mix
 Product strengths and weaknesses

o Perceptual mapping

 Product life cycle management and new product development


 Brand name, brand image, and brand equity
 The augmented product
 Product portfolio analysis

o B.C.G. Analysis
o Contribution margin analysis
o G.E. Multi Factoral analysis
o Quality Function Deployment

 Marketing Strategy - segmented marketing actions and market share objectives

 By product,
 By customer segment,
 By geographical market,
 By distribution channel.

 Marketing Strategy - Price

 Pricing objectives
 Pricing method (eg.: cost plus, demand based, or competitor indexing)
 Pricing strategy (eg.: skimming, or penetration)
 Discounts and allowances
 Price elasticity and customer sensitivity
 Price zoning
 Break even analysis at various prices

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 Marketing Strategy - promotion

 Promotional goals
 Promotional mix
 Advertising reach, frequency, flights, theme, and media
 Sales force requirements, techniques, and management
 Sales promotion
 Publicity and public relations
 Electronic promotion (eg.: web, or telephone)
 Word of mouth marketing (buzz)
 Viral marketing

 Marketing Strategy - Distribution

 Geographical coverage
 Distribution channels
 Physical distribution and logistics
 Electronic distribution

 Implementation

 Personnel requirements
o Assign responsibilities
o Give incentives
o Training on selling methods

 Financial requirements
 Management information systems requirements
 Month-by-month agenda
o pert or critical path analysis

 monitoring results and benchmarks


 adjustment mechanism
 contingencies (What if's)

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 Financial Summary

 Assumptions
 Pro-forma monthly income statement
 Contribution margin analysis
 Breakeven analysis
 Monte carlo method
 Isi: internet strategic intelligence

 Scenarios

 Prediction of Future Scenarios


 Plan of Action for each Scenario

 Appendix

 Pictures and specifications of the new product


 Results from research already completed

Measurement of Progress

The final stage of any marketing planning process is to establish targets (or standards) so
that progress can be monitored. Accordingly, it is important to put both quantities and
timescales into the marketing objectives (for example, to capture 20 per cent by value of
the market within two years) and into the corresponding strategies.

Changes in the environment mean that the forecasts often have to be changed. Along with
these, the related plans may well also need to be changed. Continuous monitoring of
performance, against predetermined targets, represents a most important aspect of this.
However, perhaps even more important is the enforced discipline of a regular formal
review. Again, as with forecasts, in many cases the best (most realistic) planning cycle
will revolve around a quarterly review. Best of all, at least in terms of the quantifiable
aspects of the plans, if not the wealth of backing detail, is probably a quarterly rolling
review - planning one full year ahead each new quarter. Of course, this does absorb more
planning resource; but it also ensures that the plans embody the latest information, and -
with attention focused on them so regularly - forces both the plans and their
implementation to be realistic.

Plans only have validity if they are actually used to control the progress of a company:
their success lies in their implementation, not in the writing'.

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Performance analysis

The most important elements of marketing performance, which are normally tracked, are:

Sales analysis

Most organizations track their sales results; or, in non-profit organizations for example,
the number of clients. The more sophisticated track them in terms of 'sales variance' - the
deviation from the target figures - which allows a more immediate picture of deviations
to become evident. `Micro- analysis', which is a nicely pseudo-scientific term for the
normal management process of investigating detailed problems, then investigates the
individual elements (individual products, sales territories, customers and so on) which are
failing to meet targets.

Market share analysis

Relatively few organizations, however, track market share. In some circumstances


this may well be a much more important measure. Sales may still be increasing, in an
expanding market, while share is actually decreasing - boding ill for future sales when the
market eventually starts to drop. Where such market share is tracked, there may be a
number of aspects which will be followed:

 Overall market share


 Segment share - that in the specific, targeted segment
 Relative share -in relation to the market leaders

Expense analysis

The key ratio to watch in this area is usually the `marketing expense to sales ratio';
although this may be broken down into other elements (advertising to sales, sales
administration to sales, and so on).

Financial Analysis

The `bottom line' of marketing activities should at least in theory, be the net profit (for all
except non-profit organizations, where the comparable emphasis may be on remaining
within budgeted costs). There are a number of separate performance figures and key
ratios which need to be tracked:

 Gross contribution<>net profit


 Gross profit<>return on investment
 Net contribution<>profit on sales

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There can be considerable benefit in comparing these figures with those achieved by
other organizations (especially those in the same industry); using, for instance, the figures
which can be obtained (in the UK) from `The Centre for Interfirm Comparison'. The most
sophisticated use of this approach, however, is typically by those making use of PIMS
(Profit Impact of Management Strategies), initiated by the General Electric Company and
then developed by Harvard Business School, but now run by the Strategic Planning
Institute.

The above performance analyses concentrate on the quantitative measures which are
directly related to short-term performance. But there are a number of indirect measures,
essentially tracking customer attitudes, which can also indicate the organization's
performance in terms of its longer-term marketing strengths and may accordingly be even
more important indicators. Some useful measures are:

 market research - including customer panels (which are used to track changes
over time)
 lost business - the orders which were lost because, for example, the stock was not
available or the product did not meet the customer's exact requirements
 customer complaints - how many customers complain about the products or
services, or the organization itself, and about what.

Use of Marketing Plans

A formal, written marketing plan is essential; in that it provides an unambiguous


reference point for activities throughout the planning period. However, perhaps the most
important benefit of these plans is the planning process itself. This typically offers a
unique opportunity, a forum, for `information-rich' and productively focused discussions
between the various managers involved. The plan, together with the associated
discussions, then provides an agreed context for their subsequent management activities,
even for those not described in the plan itself.

Budgets as Managerial Tools

The classic quantification of a marketing plan appears in the form of budgets. Because
these are so rigorously quantified, they are particularly important. They should, thus,
represent an unequivocal projection of actions and expected results. What is more, they
should be capable of being monitored accurately; and, indeed, performance against
budget is the main (regular) management review process.

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The purpose of a marketing budget is, thus, to pull together all the revenues and costs
involved in marketing into one comprehensive document. It is a managerial tool that
balances what is needed to be spent against what can be afforded, and helps make choices
about priorities. It is then used in monitoring performance in practice.

The marketing budget is usually the most powerful tool by which you think through the
relationship between desired results and available means. Its starting point should be the
marketing strategies and plans, which have already been formulated in the marketing plan
itself; although, in practice, the two will run in parallel and will interact. At the very least,
the rigorous, highly quantified, budgets may cause a rethink of some of the more
optimistic elements of the plans.

Approaches to budgeting

Many budgets are based on history. They are the equivalent of `time-series' forecasting. It
is assumed that next year's budgets should follow some trend that is discernible over
recent history. Other alternatives are based on a simple `percentage of sales' or on `what
the competitors are doing'.

However, there are many other alternatives - Ven:

 Affordable - This may be the most common approach to budgeting. Someone,


typically the managing director on behalf of the board, decides what is a
`reasonable' promotional budget; what can be afforded. This figure is most often
based on historical spending. This approach assumes that promotion is a cost; and
sometimes is seen as an avoidable cost.

 Percentage of revenue - This is a variation of `affordable', but at least it forges a


link with sales volume, in that the budget will be set at a certain percentage of
revenue, and thus follows trends in sales. However, it does imply that promotion
is a result of sales, rather than the other way round.

 Competitive parity - In this case, the organization relates its budgets to what the
competitors are doing: for example, it matches their budgets, or beats them, or
spends a proportion of what the brand leader is spending. On the other hand, it
assumes that the competitors know best; in which case, the service or product can
expect to be nothing more than a follower.

 Zero-based budgeting - In essence, this approach takes the objectives, as set out in
the marketing plan, together with the resulting planned activities and then costs
them out. Differences between marketing and business plans.

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Marketing Research & Information


In Endurance there are three major components at the market information system.

1. Internal market information


2. Marketing Intelligence
3. The marketing research project

Marketing Information system

Internal Accounting Marketing Marketing Marketing


System Intelligence Research Management
System System Science

Storage & Evaluation Evaluation Evaluation


Recall on demand Editing & & Editing & Editing
Dissemination

Management Information Systems Department


Computer related this department performs operations. E.R.P. BAAN Package is used.

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SWOT ANALYSIS

. Millennium Institute Management.


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SWOT Analysis
Strengths, Weaknesses, Opportunites and Threats (SWOT).
SWOT analysis is a tool for auditing an organization and its environment. It is the first
stage of planning and helps marketers to focus on key issues. SWOT stands for strengths,
weaknesses, opportunities, and threats. Strengths and weaknesses are internal factors.
Opportunities and threats are external factors. At the bottom of this page are FREE
SWOT examples - so please read on.

Strengths: attributes of the organization that are helpful to achieving the objective.

Weaknesses: attributes of the organization that are harmful to achieving the objective.

Opportunities: external conditions that are helpful to achieving the objective.

Threats: external conditions that are harmful to achieving the objective.

Strengths

 Specialist marketing expertise.


 A new, innovative product and service.
 Location of your business.
 Quality processes and procedures.
 Price and schemes.
 Plant location and layout.
 Collabration with Lupin Pharmaceutical

Weakness

 Lack of personnel expertise.


 Small turnover of company.
 Location of vedors are away from plant.
 Pamaged reputation.
 A weakening economy.
 Lack of integration between offline and online resources.
 Some departments not knowing what others are doing.

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Opportunities

 A developing market such as the Internet.


 Mergers, joint ventures or strategic alliances.
 Moving into new market segments that offer improved profits.
 A new international market.
 A market vacated by an ineffective competitor in generic medicine.
 More space for growth.

Threats

 A new competitor in your home market.


 Price wars with competitors.
 A competitor has a new, innovative product or service.
 Competitors have superior access to channels of distribution.
 Taxation is introduced on your product or service.
 Change in consumer attitude.
 An increase in unemployment.

Simple rules for successful SWOT analysis.

 Be realistic about the strengths and weaknesses of your organization when


conducting SWOT analysis.
 SWOT analysis should distinguish between where your organization is today, and
where it could be in the future.
 SWOT should always be specific. Avoid grey areas.
 Always apply SWOT in relation to your competition i.e. better than or worse than
your competition.
 Keep your SWOT short and simple. Avoid complexity and over analysis
 SWOT is subjective.

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CONCLUSION

. Millennium Institute Management.


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CONCLUSION

At last coming to conclusion I would like to add ‘ Aims and Objectives’ came
true during implant training.

The best thing to share about implant training is that whole implant environment
come in front of me and now further it is easy to breath comfortably in plant.

Any companies efficiency based on chemistry of various departments such as


personnel, finance, marketing purchase etc. to go head with competency company have to
manage this chemistry of departments. Each department of organization has it’s specified
area of work. But to work in total co-ordination it is very much essential that every
employee should have general idea about the objectives and functions of each
department. It also makes the communication and work pattern much more easier and
smoother. All these are only possible through proper induction and implant training
which we have experienced.

About Concept Pharmaceutical Ltd. Is well going on up warding path.


‘Ofloxacin’, ‘Becef’, ‘Concitone’, ‘Disogel syrup’ are some brands having huge market
and company’s motivated human resource taking effort to grab each and every
opportunity. Company’s strengths dominate the weaknesses and trying to achieve more.
As concern to future strategy of company, it ensures many new brands of company will
touch the new milestones.

But with the positive side company have to see also another side of coin, as some
weaknesses which might be dangerous in long run if not given proper attention.
Competitors like Ranabaxy, Wockhardt, Cipla, FDC etc are stronger and well positioned
in market segment. To overcome them in market company should have apply new
policies and strategies.

Also company has well scope in international market. If company retain same
position, it ha bright future. If company invest amount in purchasing advance machinery
it well help to improve quality as well boost companies’ image in market.

. Millennium Institute Management.


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