British Standards Institution

BSI CHECK LIST FOR WHO GMP INSPECTION

1. GENERAL:

1.1 Date of Inspection

25th to 28th March 2008.

1.2 Name of the company

Hindustan Latex Ltd.
Plot No. 16 A/1 CSEZ, Kakkanad, Cochin – 682 037

1.3 Organizational chart of the Company (attach a copy)

Copy attached as Annex 1

Categories of Drugs / Products Manufactured

Female Condom (Nitrile Latex- Lubricated)

1.4 Do the firm/ company have a written quality policy? If yes, obtain a copy of the
Same and attach.
YES . Copy attached as Annex 2

1.5 Names of the members of the inspection team

NAME DESIGNATION SIGNATURE

1. VIJAY KUMAR MAGAN Team Leader

2. S. MADHAVAN Team Member

3. ------ ----

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2. PERSONNEL

(i) Name of Incharge Qualification Whether Present/

Approved or not absent

a) Mr. G.Krishna Kumar B -Tech yes present

(Unit Chief)
b) Mr. Mahesh Kumar P. R B -Tech ---- present
(Unit In Charge)
c) c) Mr. Rajesh G Joseph B -Tech ---- present
( Production)
d) Miss. Lijy T K M -Tech ---- present
(Quality Control)
e) Mr. A. Muraleedharan M-Tech ----- present
f) Ms. Smitha B-Tech / MBA ----- present
g) Mr. Venugopalan B-Tech ----- present

(ii) Number of Production Supervisors.

Mr.ALBY

(iii) Number of Analysts QA staff.

Mr. Lawrence and Mr. Sajith

(iv) Are Production and quality functions independent of each other?

Yes

(v) Are all sections adequately staffed (Supervisor / Asst. Mfg. Chemist) taking into
Consideration the work load?

Yes. Testing personnel needs to be FDA approved.

(vi) Is recruitment of an employee preceded by medical examinations?
Yes. Recruitment of employee could be preceded by medical check-up instead
of a certificate of physical fitness

(vii) What is the periodicity of subsequent medical examinations?

Once a year (Reference – site master file: Section 2. Personnel; sub-section 2.4
Health Requirement)

(viii) Is an employee whose state of health is doubtful immediately removed from work
site until he is fully recovered?
Yes. (Reference – site master file: Section 2. Personnel; sub-section 2.4 Health
Requirement)

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(ix) Do all personnel receive WHO GMP's training?

Yes. (Training included revised schedule M requirements of FDA pertaining to
GMP, and ISO 13485:2003)
(x) Is training documented?
Yes
(xi) What is the periodicity of training?
As the unit started in Nov 2007, only one training has been carried out in 2007.
(xii) Are protective steps against likely damage to health due to occupational hazards
satisfactory?
Generally yes. However, chairs used by various operators at visual checking,
electronic testing, etc.., needs to be ergonomically designed. Currently make-shift
arrangement is being made.

S.NO. CATEGORIES COMPLIANCE REMARK/

Y/N/NA COMMENTS
3. PREMISES

(i) Are there are source of pollution in the neighbourhood of N East – Road
the building? South – Road
West – Software
North - Road

(ii) Is plant layout of suitable size design & construction Y Site master file is
sufficient for production and quality control of drug being maintained
produced?

(ii-a) Any open drain, blocked sewer or public lavatory nearby? N No drains inside
the production
area.
(iii) Is there adequate space for equipment, material and Y
movement of personnel and material?

(iv) Is there any programme to check entry of birds, rodents Y Procedure CEZF
and insects? 28 includes pest
and rodent
control.
Procedure /
Program may
include control
for entry of birds
and insects

(iv-a) Are any products other than drugs manufactured in the N

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same building?

(v) Are buildings and facilities properly constructed to Y CEZF28

facilitate adequate cleaning and sanitization?

(vi) Are lighting and Ventilation adequate? Y

(vii) Are facilities for changing street clothes, footwear, Yes (Partially) Facility for
washing and toilets adequate and satisfactorily changing street
maintained? clothes,
footwear for
visitors may be
considered.

(viii) Are sewage, trash and other effluent disposal adequate? Y Discharged into
common
sewage
treatment plant

(ix) Whether production of other specified products like NA

hormones, cylotoxic drugs segregated or whether
production is carried out on campaign basis.

(x) State of maintenance of building (Check whether the Y Organization

firm/company have preventive maintenance programme) may consider
maintenance
program for
building with
respect to
painting, etc.,
Building stability
certificate as per
Indian Factories
Act could be
done.

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(xi) Are floors, walls and ceiling properly constructed and Y Requirements of
easy to clean, maintain and disinfect? Schedule M-III
of Drugs and
Cosmetics
Rules 1945 for
buildings could
be followed.

(xii) Is there any programme for general housekeeping? Y CEZF09

S.NO. CATEGORIES COMPLIANCE REMARK/

Y/N/NA COMMENTS
4. STORAGE OF STARTING MATERIALS
No Physical
(i) Are there physically segregated areas for N segregation of
- Raw materials? RM & PM
- Packaging areas. These
are stored in
the same
room with
proper area
identification.

(ii) Is there quarantine area for incoming raw material? Y Quarantine/

Rejected
material is
part of
finished
good area. A
separate
quarantine
area could
be
considered.
(iii) Is there segregated area for rejected material? Y

(iv) Are there separate areas for material requiring special

storage conditions e.g., NA
- controlled temperature?
- Flame proof?

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(v) Are the areas adequate for storage of the materials in Y Adequate for
relation to their amount and facilities provided? current level
of single shift
production

(v-a) Do all containers of active RMs excepients and Y Labels

intermediates bear appropriate labels at all stages of available for
manufacture? all stages
If no, give details

(v-b) Are empty containers freed of old labels and checked NA

immediately prior to use?

(vi) Is lighting and ventilation adequate in warehouse? Y

(vii) Have the areas requiring special storage conditions Y Temperature

provided with monitoring devices and data maintained? and humidity
meters are
provided
(viii) Is there any programme for general housekeeping? Y

(ix) Is there any evidence of entry of insects, rodents & birds? N

(x) Are there warehousing operating instructions? Y S.O.P

evidenced.
Ref. CEZF
(xi) Are these instructions being followed? Y 25

(xii) Are there labels for materials of different status i.e., Y White -
quarantine, tested and released for use and rejected? accepted;
Pink –
(xiii) Are there labels of different colours? Y rejected;
Yellow -
Quarantine

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S.NO. CATEGORIES COMPLIANCE REMARK/

Y/N/NA COMMENTS
(xii-a) Are labels on containers of RMs to be used in
manufacture checked with regards to identity, quantity, & Y
QA approval? If no, give details.

(xiv) Are there the following information on labels?

- name of material? Y
- Batch number? Y Date of
- Analysis number? N testing in
- Date of release/ rejection? Y incoming
- Date of expiry? Y material
- Date of testing? N record

(xv) Is the sampling performed by Qualities Control Y

personnel? CZEF08,
CEZF23
(xvi) Are there sampling procedures? Y

(xvii) Are there the following information of each sample CZEF08

taken?

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- Name of person who performed sampling? Y

- Number of samples taken? Y
- Number of containers sampled Y
- Date of sampling? Y

(xviii) Are the containers provided for storage of raw materials

suitable to preserve the quality? Y CEZF26

(xix) Is there stock rotation programme (i.e., FIFO)? Y

(xx) Are the printed packaging material stored in orderly

manner and well separated to prevent mixing? Y CEZF26

(xxi) Are they recorded on stock cards/registers? Y

(xxii) Are enclosed and locked areas provided for storage of

narcotic or highly toxic drugs? NA

(xxiii) Is exterior storage available:

- Solvent storage area? NA
- Inflammable material storage area? NA
- Whether safety measures provided have been NA
assessed by regulatory agency if any?
- Are SOP’s available for handling of these NA
materials?

S.NO. CATEGORIES COMPLIANCE REMARK/

Y/N/NA COMMENTS
5. WEIGHING AREA

(i) Is the weighing area segregated? Y Separate area

provided
(ii) Are lighting and ventilation adequate? Y

(iii) Is the area clean? Y

(iv) Do the personnel wear appropriate clothing? Y

(v) Is there danger of cross contamination during weighing? N

(vi) Are the scales & balance calibrated regularly and records Y
maintained? CEZF32R01

(vii) Are the containers of the raw materials to be weighted, Y

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cleaned before opening?

(viii) After weighing, are these containers sealed? Y

(ix) Are the raw materials for each batch, after weighing Y
properly identified?

(x) Are adequately clean and dried equipments used for

dispensing materials from the containers? Y

6. EQUIPMENT

(i) Is the equipment adequate for intended use? (State size, Y

capacity and check batch size)

(ii) Is it constructed in such a way that lubricants coolant, etc. Y

cannot contaminate the drug product?

(iii) Does the equipment permit cleaning and maintenance? Y

(iv) Does the equipment show its status i.e., clean, dirty, batch Y
contents?

(iv-a) Do all apparatus/equipment bear appropriate labels to

identity the product for which the equipment is used, its NA
batch no., date, etc.?

(v) Are SOPs available for cleaning , maintenance and

sanitization Y CEZF27

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S.NO. CATEGORIES COMPLIANCE REMARK/

Y/N/NA COMMENTS
(vi) Are log books maintained for cleaning, maintenance and Y CEZF 27
sanitization of major equipment?

(vii) Are SOPs readily available to operators? Y CEZF27

(viii) If automatic electronic or mechanical equipment is used, Y

are there?
- Written programmes for calibration/ inspection. Y CEZF32
- Records of such programmes? Y CEZF32R01,
- Checks to ensure that any changes are made Y CEZF32R02
only by authorised person?

7 FACILITIES AND UTILITIES

(i) Are air handling units adequate and properly located Y The
and functional? condensing
units of air
(ii) Is air conditioning system adequate and functional? Y conditioners
are installed
in finished
goods storage
area leading
to increase in
storage room
temperature
beyond 35*C
required for
the storage of
finished
goods.
(iii) Are steam generation facilities adequate and NA
functional?

(iv) Are vacuum system adequate and functional? Y For package

sealing
(v) Is compressed air system adequate and properly Y
functioning?

(vi) Is water supply system adequate? Check whether MC Y

or Tube well supply. If tube well supply, whether
potable?

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(vii) Is distilled water qualities and supply system NA

adequate?

(viii) Is demineralised water quality & supply system NA

adequate?

(ix) Sanctioned power ____________ Y 60 KW

(x) Generator ______________ KVA provided N No generator

is provided.

S.NO. CATEGORIES COMPLIANCE REMARK/

Y/N/NA COMMENTS
7-A SANITATION AND HYGINE

(i) Are cleaning schedule available for:

- floors? Y Cleaning
- walls? N schedule
- ceiling? N might include
- doors & windows? Y walls and
- electrical fittings? Y ceiling apart
from floor,
For different sections. door,
windows, etc.,

(ii) Are SOPs available for cleaning & sanitization? Y CEZF09

(iii) Are disinfectants used rotated? Y CEZF09

(iv) Is microbial load monitored in different sections? N Bio-burden

test
(v) Is microbial load monitored in different sections? N conducted at
packed
stage

(vi) Are adequate facilities available for personal hygiene Y

before entering into production area?
CEZF28
(vii) Are personnel instructed to observe personal hygiene? Y

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(viii) Are clean protective clothing provided to personnel? N

(ix) Are clean sterile protective clothing changed every time a NA

person enters sterile area?

8. PRODUCTION AND IN-PROCESS CONTROL

(i) Is there master production document for each drug Y CEZF 11

product being produced?

(ii) Are alterations to processes recorded and authenticated by Y

competent authorized persons?

(iii) Is the addition of components verified by another person? Y

(iv) Is an appropriate in-process control being performed? Y CEZF20

(v) Are non sterile products tested for microbial load &
whether microbial load is less than limits recommended Y CEZT015
by WHO?

S.NO. CATEGORIES COMPLIANCE REMARK/

Y/N/NA COMMENTS
(vi) Are adequate measures taken to prevent cross NA
contamination during production of different products in
the same facility?

(vii) If drying ovens are used:

- Whether one product is dried at one time? N

(viii) Are instrument used for temperature, pressure or other CEZF32R01,

recording calibrated periodically and records maintained. Y CEZF32R02

(ix) Are semi-finished products stored properly and are Y

identified?

(ix-a) Is stage of manufacture clearly indicated on containers? Y

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(x) Is quality of water monitored? Y Water is

The following points may be checked? supplied by
- source of water? CEZ who
- Is it potable? monitor the
- In case de-ionized water source of feed water? quality of
- Frequency of charging columns sampling water.
frequency?
- In case of water for injection information like:
- Is it prepared by distillation or reserve osmosis?
- Whether storage temperature is maintained at
not less than 800C and circulated?

(xi) Do the containers and closures meet required Y

specification?

(xi-a) Are containers checked for cleanliness and suitability for Y

packaging before use?
CEZF08
(xi-b) Are containers of intermediates FPs intended for use in Y
the plant closed property?

(xii) Is homogeneity maintained during filling of ointment, NA

creams and lotions?

(xiii) Are the following controls carried out during filling

operations:
- checks of column, weight or counts? Y
- Visual inspection of empty and filled Y
containers?
- Visual inspection of closures? Y CEZF23

S.NO. CATEGORIES COMPLIANCE REMARK/

Y/N/NA COMMENTS
(xiv) Is there adequate separation of packaging lines to prevent Y Only one line
mix-ups? exist

(xv) Is each line identified with name of the product, batch no. Y
and packaging size?

(xvi) Is there only one batch of product on packaging line at Y

any given time?

(xvii) Is an inspection carried out of each packaging line before Y

labeling and packaging operation?
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(xviii) Is the inspection verified by quality control? Y

(xix) Is significant discrepancy in actual yield investigated? Y

(xx) Is inspection carried out of each packaging line after

operation to ensure that all excess/rejected labeling Y
material are removed? CEZF10

(xxi) Are all excess or rejected coded labels and cartons Y

destroyed? CEZF 21

(xxii) Is batch production record prepared for each batch of Y

product and maintained? CEZF23

(xxiii) Do the batch production records indicate that each Y

significant step in manufacturing was performed and CEZF23 R10
checked by second individual wherever appropriate?

(xxiv) Are master instruction or procedures being followed? Y

Provided in
(xxv) Are these instruction and procedures being followed? Y SOP

(xxvi) Are only materials, containers and appliances necessary Y

for the job in hand stored in the vicinity of the
manufacturing areas and are these properly labeled with
name of the product, batch no.. date, etc.

S.NO. CATEGORIES COMPLIA REMARK/

NCE COMMENTS
Y/N/NA
9. PRINTED LABELLING AND PACKAGING
MATERIAL CONTROL

(i) Is specimen copy of each label and printed packaging

material approved before sending it to the printer? Y

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(ii) Are label and other printed packaging material checked Y CEZF08
and approved by quality Control before release to
production.

(iii) Is access to labels and other printed packaging material Y CEZF 45

store limited to authorized persons?

(iv) Are there any designated individuals to control and issue

labels and other printed packaging materials? Y CEZF 45

(v) Are individual labels stored separately? Y

(vi) Are printer’s count accepted or counted by factory worker Y

for inventory purposes?

(vii) Do batch production records indicate:

- Number of labels or other printed packaging Y CEZF 45
materials to be issued? Y
- Batch or control code? Y
- Reconciliation of number/ amount of labels and Y
printed packaging materials issued, used and
destroyed?

10. QUALITY CONTROL

(i) Are master control procedures:

- Signed and dated by responsible persons? Y

(ii) Do these control procedures include specifications, test

procedures or other control procedures for:
- Raw materials? Y CEZF 08
- In-process materials? Y CEZF 20
- Packaging and labeling materials? Y
- Finished products? Y CEZF23

(iii) Are the procedure in written form and readily available to Y Provided in SOP
QC personnel?

S.NO. CATEGORIES COMPLIA REMARK/

NCE COMMENTS
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Y/N/NA
(iv) Are there procedures and specifications for acceptance of Y CEZF12
reprocesses materials?

(v) Are there written sampling procedures for:

- raw materials? Y CEZF 08
- Packaging and labeling materials? Y CEZF 20
- Finished products? Y CEZF 23

(vi) Are samples collected by QC personnel? Y

(vii) Is there special room for microbiological and sterlity NA

testing?

(viii) Is the environment of room controlled? Y

(ix) Cultures, Sub cultures:

- Are microbial strains obtained from NA
authorized / reputed source?
- Frequency of Sub-culturing.
- frequency of identification of organism by
microscopical or biochemical test
- Are records of subculturing and identification of strain
maintained

(x) Are animal test performed? NA

(xi) Are animal properly housed? NA

(xii) Are the temperature and humidity of animal house NA

controlled?

(xiii) Are records of animals used maintained? NA

(xiv) Are the animal quarantined on receipt and examined for

infection / disease? NA

(xv) Is access to animal house restricted to authorized persons? NA

(xvi) Is fresh water and animal feed available in animal house? NA

(xvii) Are all raw materials , containers, closures, labels and

printed packaging materials approved and released by QC Y
for use in manufacture of drug product?

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S.NO. CATEGORIES COMPLIANCE REMARK/

Y/N/NA COMMENTS
(xviii) Are in-process controls carried out by QC personnel? Y CEZF20

(xix) Are semifinished products tested for appropriate tests Y

when necessary?

(xx) Is bulk finished products tested for established NA

specifications before packing?

(xxi) Is every finished products tested for established

specifications before release for sale? Y CEZF23

(xxii) Are there any deviations from established procedures or N

specifications and are these justified?

(xxiii) Does the QC maintain records of all the test carried out? Y

(xxiv) Does the QC reviews all production and control records CEZF23R10
to ensure compliance with established written procedures Y
before a batch of the products is released for sale?

(xxv) Reference Standards:

(a) Are reference standards (R.S.) available? Y
(b) Are these primary or working R.S.?
(c) Are working RS calibrated against primary R.S> Display
or C.R.S.? boards
(d) Are R.S. stored properly ( at low temperature Y available in
under dehumidified conditions)? production
(e) Are records of R.S. and their calibration unit
maintained?

(xxvi) Are samples in sufficient quantity for testing twice Y Retained

retained of starting materials and finished products for samples for
future examination, in case of need? conducting all
the test once
is kept

(xxvii) Is written programme available for stability studies Y Stability study

including the following: conducted by

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- Sample storage condition? F.H.C is

- Room temperature? referenced in
- Accelerated ageing test? the technical
- Sample size and test intervals? file.
- Reliable and specific test methods?
- Testing in the same containers closure system
in which it is marketed?
- Date and expiration date?

S.NO. CATEGORIES COMPLIANCE REMARK/

Y/N/NA COMMENTS
11. STORAGE OF FINISHED PRODUCTS

(i) Is the area adequate with reference to materials stored? Y CEZF25

(ii) Are lighting and ventilation adequate? Y

(iii) Whether special areas with temperature and humidity Y

control required? Have these been provided?

(iv) Is there stock rotation programme (FIFO)? Y

(v) Are the inventory records to show: CEZF25R01

- amounts? Y
- Batch number? Y
- Date of receipt? Y

(vi) Have distribution records been maintained? Y

(vii) Do distribution records provide sufficient information for Y CEZF25R01

drug recall purpose?
Is there segregated area for retrieved goods? Y
Are records available for retrieved goods? N No retrieved
12. DOCUMENTATION goods

(i) Are SOPs available for the following:

- receipt of raw materials and other components? Y CEZF38
- Quarantine and storage? Y CEZF38,
- Quality control system and approval/rejection? CEZF26
- Release to production? Y CEZF29
- Weighing and dispensing? Y CEZF25
- Processing and production operations? Y CEZF25
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- Packaging and labeling? Y CEZF05

- Quality control? Y CEZF19
- In-process? Y CEZF29
- Finished products? Y CEZF20
- Storage of finished products? Y CEZF25
- Distribution? Y CEZF25
- Returned goods? Y CEZF25
- Recalls and complaints? Y CEZF 43
- Cleaning and maintenance? Y CEZF43
- Quality control of water? Y CEZF09
- For reworking of nonconforming batches in Y CEZT 20
existence? Y CEZF21
If yes, check records.
S.NO. CATEGORIES COMPLIANCE REMARK/
Y/N/NA COMMENTS
(ii) Have these SOPs been prepared, signed and dated by Y Provided in
responsible person? SOP

(iii) Are there additional documents like log books, notebooks Y

or other similar records available to show execution of CEZF11R04
various functions?

(iv) In case of review and changes, are SOPs signed by Y QMS 04B
responsible person and do these shoe their date of
effectiveness?

(v) Are there records of receipt of raw materials and do these

have following information? (Goods Receipt Note-GRN)
- Receiving GRN document number? Y
- Date of receipt? Y
- Supplier? Y CEZF 38R01
- Manufacturer? Y
- Manufacturer’s batch number? Y
- Type and size of containers? Y
- Number of containers and conditions? Y

(vi) Are there records of stock and issue of raw material and
do these have following information:
- Opening balance? Y
- Date of receipt Y CEZF 26R05
- Quantity received? Y
- Name and batch number assigned by the Y
manufacturer?
- Invoice number, date, name and address of Y
supplier?
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- Analysis report number and date? N

- Date of expiry Y
- Date of issue? Y
- Name and batch number of product for Y
manufacture of which issued?
- Balance? Y
- Signature of issuing persons? Y

(vii) Is there a master formulation record for each drug Y One device
product being produced? being
manufacture
(viii) Is there a separate master production documents for each Y d for which
dosage form/ batch size? dosage
quantity of
Silicone Oil
is deined
S.NO. CATEGORIES COMPLIANCE REMARK/
Y/N/NA COMMENTS
(ix) Are these master production records signed and dated by Y
competent person? Do they show the following
particulars:
- the name, strength and description of the dosage
form?
- Name and quantity of each active ingredient per
dosage unit or per unit of weight or measure of
the drug product?
- The total weight or measure of any dosage unit?
- A complete list of components identified by the
name/codes?
- An accurate statement of the quantity of each
component?
- Calculated excess of component, if any?
- Theoretical weight or measure at appropriate
processing stage?
- Description of containers, closures and
packaging materials?
- Complete manufacturing instruction?
- Sampling and testing procedures?
Including in-process controls?
Specifications and precaution to be taken?

(x) Is a batch production record prepared for every batch Y CEZF11R01

produced?

(xi) Is it reproduction of the appropriate master production

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documents or it has all critical information about the Y

batch.

(xii) Has it been checked for accuracy signed and dated by a Y

responsible person?

(xiii) Are the records maintained by QC for all the test carried Y
out?
Do these records include:
- graphs, chart, spectra, etc? Y CEZF46RO1
- calculations? Y
- Signatures of individuals who performed the Y
test?
- Signatures of the designated person responsible
for the review of records for accuracy and Y
compliance with established standards?

(xiv) Are other associated records available? Y

S.NO. CATEGORIES COMPLIANCE REMARK/

Y/N/NA COMMENTS
(xv) Is documentation available readily for examination? Y

(xvi) Where errors have been made in entering or transcribing

data:
- Have errors been crossed out with one line?
- Have corrections been made above those Y
crossed out?
- Are corrections dated and initialed?

(xvii) Are batch production records capable of giving complete Y CEZF11R01

history of the batch right from the RM stage to the
distribution of FP?

13. CALIBRATION OF INSTRUMENTS AND

MEASUREMENT SYSTEMS

(i) Are the balances calibrated routinely? Y CEZF32R01

(ii) Have measuring equipments been calibrated? Y CEZF32R01

(iii) Have thermometers/thermocouples been calibrated? Y CEZF32R01

(calibrated range) CEZF32R02
Minimum-25ºC
Maximum-35ºC
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(iv) Have the pressure gauges been calibrated? Y

(v) Are instruments routinely calibrated? Y

(vi) What is the periodically of calibration? Y 6 months/ 1

year
(vii) Are records maintained for all calibration? Y

Note: Draw a list of all major instruments available and check List of
calibration records? instruments
under
calibration is
maintained.
CEZF 31

14. VALIDATION AND REVALIDATION

(i) Are validation studies carried out for the following:

- Cleaning and sanitation procedures? N
- Process? Y
- Testing? Y

(ii) Have qualification studies been carried out for equipment Y CEZF31
before validation studies?

S.NO. CATEGORIES COMPLIANCE REMARK/

Y/N/NA COMMENTS
(iii) Are validation protocols available for validation studies? Y

(iv) Do the validation reports show recorded results and Y

conclusions?

(v) Are validation studies carried out periodically? Y Only one

validation
(vi) Is revalidation carried out in event of significant change Y carried out on
in material (s) or equipment? 17.12.2007

Note: Check a few qualification and validation studies in Validation

details: report
17.12.2007
checked.
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15 COMPLAINTS

(i) Are there written procedures for handling complaints? Y Documented

procedure for
(ii) Is an investigation carried out wherever necessary handling
including discussion with manufacturing personnel? customer
complaint
(iii) Are complaints reviewed by QC? CEZF 43.So
far no
(iv) Is there a designated person for overall evaluation? customer
complaints
(v) Are records maintained for complaints and do these received.
include the following:
- name of the product with strength?
- Batch number?
- Name of complainant?
- Nature of complaint?

(vi) Is a report of investigation made?

(vii) Are complaints involving adverse reactions evaluated by

qualified personnel?

(viii) In case of significant adverse reaction, are appropriate

Health Authorities notified?

16. PRODUCT RECALLS

(i) Is there written procedure for product recall in case of Y Documented

products known or suspected to be defective? procedure for
product recall
(ii) Is there a designated person responsible for execution and Ref.
coordination of product recalls? Y CEZT024
No product
recall till date.

S.NO. CATEGORIES COMPLIANCE REMARK/

Y/N/NA COMMENTS
(iii) Have the degrees of recall been specified (i.e., Degree I, Degree of
degree II and Degree III) recall not
specified.
(iv) Is the following information available? Y
- fax, telex, telephone number and addresses of
national, regional and local regulatory
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authorities?
- Fax, telex, telephone number and addresses of
radio, television and press agencies?
- Fax, telex, telephone number and addresses of
distributors, wholesalers, hospitals, etc.?
- Fax, telex and telephone numbers and addresses
of competent authorities of the countries to
which the drug products are exported?

(v) Is there a system so that distribution records are readily Y

available to the designated person responsible for product
records?

(vi) Is the progress of product recalls recorded and final NA

report issued including reconciliation between the
delivered and recovered quantities of the product? No recalls
reported.
(vii) Is the effectiveness of product recall evaluated from time NA
to time.

(viii) Is there a segregated area for recalled product? N

No segregated
area for
recalled
product
considered in
the lay-out.
17. RETURNED AND SALVAGED DRUG PRODUCTS
CEZT 23
(i) Are written procedures available for receipt and control Y
of returned products?
No product
(ii) If a reason for returning the product implicates other returns
batches is an investigation made and reports prepared? reported

(iii) Are returned or salvaged drug products destroyed unless

QC determines their reprocessing?

(iv) Are records of returned products maintained including

their disposition?

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S.NO. CATEGORIES COMPLIANCE REMARK/

Y/N/NA COMMENTS
(v) Are there written procedures for reprocessing and do
these include.
- Specifications and characteristics for approval?
- Identification of batch to reflect reprocessing?
- Revised stability data, if necessary.

18. SAFETY

(i) Is a safety manual available? NA Safety manual

not available.
(ii) Are safety equipments like helmets, shoes, goggles, However,
glove, showers, aprons, masks, breathing apparatus, etc., emergency
available in the factory? preparedness
plan and
(iii) Is adequate first aid equipment available at convenient Y response for
place in the factory fire and
spillage is in
(iv) Is periodic first-aid training given to staff? place.

(v) Are electrical connections, wiring etc. checked regularly? Y

Necessary
(vi) Is flame- proof equipment used where flammable safety
solvents or materials are stored or handled during NA equipments
manufacture? are available

(vii) Is adequate fire fighting equipment like fire Only fire

extinguishers, ladders, fire buckets filled with water/ Y extinguishers
sand, etc., available? are provided.

(viii) Are staffs trained in fire fighting operation? Y

(ix) Is the building safe and provided with emergency exit, Emergency
escape routes ladders, etc? Y exits in
building must
(x) Does the firm maintain accident history/record? open outside
If yes, comment on its adequacy. Y

19. POLLUTION CONTROL

(i) Are arrangements for the following adequate?

(ii) Disposal of solid/semi-solid waste? NA

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(iii) Disposal of sewerage? NA

S.NO. CATEGORIES COMPLIANCE REMARK/

Y/N/NA COMMENTS
(iv) Disposal of liquid laboratory waste? NA

(v) Management of gaseous pollutants? NA

(vi) Is effluent treatment plant in existence? NA

If Yes, comment on it.

(vii) Are fume hoods of adequate design in existence and used NA

wherever necessary?

20. RESULTS OF PREVIOUS SELF INSPECTION AND Y GMP

CORRECTIVE MEASURES TAKEN inspection
done
(i) Is the report of previous self-inspection available? Y internally
once in 6
(ii) Recommendations of previous self-inspection? Y months. Last
inspection
done on
(iii) Whether corrective measure have been taken as Y 14.01.2008
recommended by previous self-inspection team?

PARENTERAL SECTION

1. Whether separate sections are provided for preparation of

the containers and closures. Preparation of solution,
Filling and Sealing Serilisation.

2. Equipment: Whether as per shedule M Manufactring

Area: NA
i) Shortage equipment for ampoules, vials;
bottles and closures.
ii) Washing and drying equipment.
iii) Dust proof shortage cabinet.

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iv) Water still.

v) Mixing and preparation tanks or other NA
containers.
vi) Mixing equipment where necessary
vii) Filtering equipment
viii) Hot Air Steriliser

Asceptic Filling and Sealing Rooms:

ix) Bacteriological filters.
x) Filling and sealing unit under laminar flow
work station.

NA

S.NO. CATEGORIES COMPLIANCE REMARK/

Y/N/NA COMMENTS
General Room:
xi) Inspection room
xii) Leak testing equipment
xiii) Labelling and packing benches
xiv) Storage equipment including cold storage and
refrigeration, if necessary.

3. Whether rubber closures used are of natural or synthetic NA

origin. Whether closures properly cleaned and sterilized
(note the method). Are they tested as per ISI standards.
Whether the cleaning schedule on container and closures
maintained.

4. Whether the sterile containers and closures are moved to NA

the filling area without exposure in non-sterile area. Are
the following rooms with proper facilities provided
before entry in to the sterile area:

i) A room for removal of street clothes and

shoes provided with cupboards and racks etc.
ii) A room for washing & changing into sterile
overalls.

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iii) An airlock.

5. Whether personnel entering in the sterile area wear clean NA

sterile uniform. Head cover, footwear, masks and gloves
Made of such material which are not likely to shed fibres
(nylon, Dacron etc.)

6. Whether movement of personnel is restricted in the sterile NA

area.

7. Whether special procedure has been established for

entering and leaving the manufacturing area and sterile NA
area. Is the procedure displayed at the entrance of the
manufacturing area.

8. Are the furniture provided in the section satisfactory Y

(smooth and washable).

9. Whether sufficient UV lamps are provided in the airlock NA

and hatches.

10. a) Is the efficacy of UV lamps monitored? (Check NA

whether their daily burning hours are recorded and they
are changed after they have burnt the specified hours.)
S.NO. CATEGORIES COMPLIANCE REMARK/
Y/N/NA COMMENTS
b) Are the UV lamps cleaned periodically? NA

11. Whether the solution preparation room and filling and NA

sealing rooms are air conditioned and provided with
filtered air to keep positive pressure. ( State the air-
conditioning system-central or individual air-conditioners
and the class of air cleanliness).

12. Whether ascptic handling is necessary and if so, whether NA

central air conditioners with HEPA filters are provided.

13. Whether distillation units properly and frequently cleaned NA

to eliminate contamination, pyrogenous matter,
particulate matter, etc.

14. Whether distilled water still is so designed to avoid mix-

up of water spra condensed water. Write the model of NA
DW plant used.

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15. Whether fresh distilled water is used for NA

a) Manufacturing operations (it should be within 3-4
hrs, of collection. If storing is necessary, it should
be stored at 800C and above).
b) Is the bulk distilled water tested for pyrogen?
c) Whether adequate precautionary measures are
taken to avoid contamination during collection
and transfer of distilled water to the solution
preparation room.

16. Whether aseptic handling is necessary. If so, whether NA

laminar airflow system is provided in the solution filling
area.

17. a) Is the plate count taken and the method used is NA

adequate?
b) Has the average number of colonies (standard
limit) been determined?
c) If so, is ir adequate (how it has been determined
and what is the limit)?
d) If the limit is higher than permissible on any day,
steps taken to find out the causes etc.
(check if the production is stopped.)

S.NO. CATEGORIES COMPLIANCE REMARK/

Y/N/NA COMMENTS
18. Are there any devices provided to note temperature of the Y
air-conditioned area?

19. Is the solution filtered (note the type of filter used,

candles sintered, glass or membrane filter)? NA
If the products are to be manufactured by aseptic
technique, do they have filtering assembly with bacteria
retaining filters. Whether the efficiency of the filters
checked before operation.

20. Whether autoclave used is adequate and is provided with NA

an automatic device to record pressure, temperature and
duration of sterlisation and whether records are

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maintained.

21. Is the effectiveness of sterilizer checked (state the type of NA

indicators used)?

22. What system has been established to separate products NA

intended for sterlisation from products already sterilized?

23. Whether the dry air sterilizers and autoclaves provided NA

have been validated for sterilization before operation and
whether recoding device is provided.

24. How is the equipment sterilized if necessary? NA

25. Whether lot Nos are given separately for different lots of NA
autoclave load in the same batch and are they separately
tested for sterility.

26. Whether the net content of the liquid is checked. NA

27. Whether leak test for ampoules is performed. NA

28. Are the finished product visually examined for suspended NA

particles. Whether visual checking unit is adequate and
satisfactory.

29. Whether adequate equipment is provided for the NA

following operations checks and these checks are being
carried-out.

S.NO. CATEGORIES COMPLIANCE REMARK/

Y/N/NA COMMENTS
i) Cutting of ampoules NA
ii) Washing of ampoules, bottles & closures. NA
iii) Drying of ampoules, vials & bottles. NA
iv) Auto claving and sterilizing NA
v) Sterilising of containers & closures. NA
vi) Manufacture of distilled water. NA
vii) Mixing, preparation & storage of solution. NA
viii) Filtration of solution. NA
ix) Filling and sealing NA
x) Testing leak. NA

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xi) Testing of foreign particles with black and NA

white background.
xii) Cold storage, if necessary NA

30. Whether the equipment are designed for thorough NA

cleaning after each batch of operation.

1. OPHTHALMIC SECTION NA
(Drops, Solutions, Ointments, Suspensions, etc.)

Equipment whether as per Schedule M

i) Hot air oven electrically heated with

thermostatic control.
ii) Kettle, gas or electrically heated with suitable
mixing.
iii) Colloid mill or ointment mill
iv) Tube filling equipment
v) Mixing and storage tanks of stainless steel of
other suitable material
vi) Sintered glass funnel seitz filter or filter
candle.
2. vii) Liquid filling equipment
viii) Autoclaves.

Are the droppers properly cleaned and sterilized

3. (check whether the droppers are packed in sterile
cellophane packing. If supplied separately)?

4. Is a suitable bactericidal agent added to the preparation

(note the percentage of the substance added)?

Are collapsible tubes cleaned with nylon brushes and

high pressure air jet?

S.NO. CATEGORIES COMPLIANCE REMARK/

Y/N/NA COMMENTS
5. What is the method of sterilizing collapsible tubes? If
ethylene oxide is used for sterilization is residual gas
removed effectively.

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6. Is a separate area provided near the ointment section for

melting, filtering and sterilization of petroleum base?
(note the arrangement for directly treasferring the sterile
base)

7. Are the coarse particles of drugs made to a fine powder

before incorporating into the ointment base? (Particle size
should be less than 50 microns in the finished products.)

8. Whether asceptic manipulations are carried out in a

conventional sterile area or under laminar flow system.

9. Whether sterile bulk materials and containers and

closures are moved into the sterile area without exposure.

10. Are the ointment tested for gross contaminations? (The

finished products must be free from Pseudomonas
aeruginosa.)

11. Whether integrity of filters test is carried (Bubble point

test) out or not in case of aseptic filling.

13. Other remarks. N

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