Professional Documents
Culture Documents
QUALITY ASSURANCE IN
Following are the certificates, which are applicable for pharmaceuticals for
regulatory or commercial purposes.
1. Indian GMP (Schedule M) Statutory from June 1988 in India.
2. International Organisation for standards (ISO 9001 & 14001)
3. World Health Organisation (WHO GMP)
4. Therapeutic Goods Administration (TGA), Australia
5. Medicines Control Council (MCC), South Africa
6. cGMP Certification from US Food and Drug Administration
7. Medicines and healthcare products regulatory authority agency (MHRA), U.K
8. International Conference on Harmonization (ICH) USA, Europe & Japan
9. Certificate of Suitability (COS) – Europe
From early 20th century there has been a rapid increase in the rate of introduction of
pharmaceutical industries. Pharmaceutical is derived from Pharmacology. Pharmacology
is a branch of science about medicinal substances called pharmaceuticals. The field
encompasses drug composition, drug properties, interactions, toxicology and desirable
effects that can be used in therapy of diseases.
Pharmaceutical is referred to as formation of medicine or medicament for use in the
diagnosis, cure, mitigation, treatment or prevention of disease. Pharmaceutical industry
comprises establishments primarily engaged in one or more of the following:
(1) Manufacturing biological and medicinal products.
(2) Processing (i.e., grading, grinding and milling) botanical drugs and herbs.
(3) Isolating active medicinal principals from botanical drugs and herbs.
(4) Manufacturing pharmaceutical products intended for internal and external
consumption in such forms as tablets, capsules, vials, ointments, powders, solutions and
suspensions.
India is the forth largest manufacturer of pharmaceuticals in the global market. It clearly
depicts that the prices of medicines in India are lowest in the world. India is paying for
quality health care. India is the growth driver for global drug companies. Indian
pharmaceuticals industry has over 20,000 units. Around 246 pharmacy industries
constitute the organized sector of pharmaceuticals in Haryana, while others exist in the
small scale sector. There has been a rapid increase in the rate of introduction of new and
potent medicines. The assessment of quality of the medicines rests with the
manufacturers. Quality remains a main issue with the assurance of product to adhere
quality. A system of quality control performed at a manufacturing site is known as
Quality Assurance. It is the sum total of the organized arrangements made to ensure that
all APIs (Active Pharmaceutical Ingredients) are of the quality required for their intended
use and that quality systems are maintained. In the face of a challenging regulatory
environment pharmaceutical companies have found ways to improve quality and costs
significantly. To drive benefits from change, companies had created a culture where
quality objectives are transparent, well understood and goals can be achieved by
following certain sets of procedures called as “Standard Operating Procedures”
(SOP). A Standard Operating Procedure (SOP) governed by World Health Organization
is a set of written instructions that document a routine or repetitive activity which is
followed by employees in an organization. A Pharmaceutical Industry has an average of
1200- 1300 SOPs and these SOPs are governed by ISO: 9000 series. There are many
leading pharmaceutical industries which adopts SOPs such as: Sun pharmaceuticals,
Torrent pharmaceuticals, pfizer India, Novartis India, glaxoSmithKline, AstrZeneca etc.
In a nut shell it can be said that “Quality Assurance has undoubtedly evolve in
pharmaceutical industries stating quality from manufacturing processes, process control,
material, staff and training, organization of department to quality manuals”.
Quality Assurance
i) It is quality control with an emphasis on quality in the design of the
products, processes and jobs in the selection of personnel and their
training.
ii) It is the system of setting the quality standards, appraising
conformance to the standards, actions taken when standards are not
met and planning changes in these standards.
Definition
All actions taken to ensure that standards and procedures are adhered to and that
delivered products or services meet performance requirements is Quality Assurance.
PHARMACEUTICAL INDUSTRIES
i) Public and private organizations involved in the manufacture of drugs and
medications.
(ii) To study the impact of Quality Certification, Annual Turnover and Investment in
the Manufacturing Plant on each Quality Factor.
D.H.Shah(2007), has explained in his book SOPs and explained that for centuries quality
has remained a complex problem. World Health Organization (WHO) SOPs as a global
initiative for controlling variability. As per the protocol published by WHO analysis of
each SOP is necessary. This method provides rapid assessment of the quality of the
products for mass distribution and currently recommended/ adopted statutory methods. A
decision tree stating the procedure of laboratory for quality assurance and control have
the following salient features: 1) efficient identification of good quality formulations ii)
assure batch-to-batch consistency with respect to quality and performance iii) facilitate
the reduction of development time and simplify the processes.
1. Primary Data
Data which shall be collected specifically for this research includes: -
i) Interview and survey of pharmaceutical company personnel which will cover lab
mangers, lab technicians and scientists through a closed questionnaire with
informed ideas about the subject of the research.
ii) Observation, recognizing and recording relevant events and activities.
iii) One-to-one interview with employees.
iv) Group interviews.
v) Observation.
2. Secondary data
i) Books
ii) Periodicals (magazines, journals)
iii) The World Wide Web for Information ‘or’ the Internet
B) Sample Design
1. Sampling Element: The basic elements which shall be studied are Plant Managers not
lab mangers, lab technicians and scientists of organized and small scale pharmaceutical
companies.
sampling will be adopted, in order to give adequate coverage to the selected area.
D) Tools Used:
A questionnaire will be formulated to collect data for the purpose to know the level of
Quality Assurance in organized and unorganized pharmaceutical companies. For the
purpose of analysis and interpretation of the data bar charts and table formats will be used
to concise the data. To calculate and analyze the results chi-square and percentage
method shall be applied.
E) Statistics Used:
The collected data will be analyzed through following statistical tools:
(i) Frequency diagrams to analyze each attribute of TQM.
(ii) Analysis of variance (ANOVA) between samples & within samples & carrying
out F-test at 5% level of significance for data collected across pharmaceutical
companies on each TQM attribute.
BIBLIOGRAPHY
Journals
1) Anuja.R. Shah & R.K.Goyal (2008), Current Status of the Regulations of
Medical Devices, “Indian journal ofPharmaceutical Sciences” Vol.14, pp.695-
700.
4) R.D.Garg & Nupur Kaul (2008) Growth of Pharmacy in Delhi, “Indian Journal
of Hospital Pharmacy”, Vol.7 (2008), pp.119-120.
6) Y.Ashokraj & Shrutidevi Aggarwal (2008) A Decision Tree for Rapid Quality
Assurance, “Indian Journal of Pharmaceutical Sciences” Vol.14, pp.1-5.
Magazines