The first WHO draft text on good manufacturing practices (GMP) was prepared in

1967 by a group of consultants at the request of the Twentieth World Health

Assembly (resolution WHA20.34). It was subsequently submitted to the Twentyfirst World Health Assembly under the title Draft requirements for good
manufacturing practice in the manufacture and quality control of medicines and
pharmaceutical specialities and was accepted.
The revised text was discussed by the WHO Expert Committee on Specifications
for Pharmaceutical Preparations in 1968 and published as an annex to its twentysecond report. The text was then reproduced (with some revisions) in 1971 in the
Supplement to the second edition of The International Pharmacopoeia.
In 1969, when the World Health Assembly recommended the fi rst version of the
WHO Certifi cation Scheme on the Quality of Pharmaceutical Products Moving
in International Commerce in resolution WHA22.50, it accepte the same time the
GMP text as an integral part of the Scheme. Revised versions of both the
Certification Scheme and the GMP text were adoptedin 1975 by resolution
WHA28.65. Since then, the Certification Scheme has been extended to include
the certification of:
veterinary products administered to food-producing animals;
information on safety and efficacy (resolution WHA41.18, 1988).
Good practices in production and quality control, provides guidance on
actions to be taken separately by production and by quality control personnel for
the implementation of the general principles of QA.
Considerable developments in GMP have taken place in the intervening years,
and important national and international documents, including new revisions,
have appeared (2,3,4,5). Thus the necessity to revise the main principles and
incorporate the concept of validation.
Among other feedback which was discussed during the consultation on WHO
guidelines for medicines quality assurance, quality control (QC)laboratories and
transfer of technology on 2731 July 2009, the need was identified to
incorporate a new section (1.6) on Product quality reviewunder Chapter 1:
Quality assurance.In addition, several updates were suggested to further
enhance the guidelines and include the concept of risk management, replacing

drugs by the termmedicines and newly introduce the concept of a quality

unit.

General considerations
Licensed pharmaceutical products (marketing authorization) should be manufactured
only by licensed manufacturers (holders of a manufacturing authorization) whose
activities are regularly inspected by competent national authorities. This guide to GMP
shall be used as a standard to justify GMP status, which constitutes one of the elements of
the WHO Certification Scheme on the quality of pharmaceutical products moving in
international commerce, through the assessment of applications for manufacturing
authorizations and as a basis for the inspection of manufacturing facilities. It may also be
used as training material for government medicines inspectors,as well as for production,
QC and QA personnel in the industry.
The good practices outlined below are to be considered general guides15,and they may be
adapted to meet individual needs.

Although there are a number of them, all guidelines follow a few basic
principles:
Hygiene: Pharmaceutical manufacturing facility must maintain a clean and hygienic
manufacturing area.
Manufacturing processes are clearly defined and controlled. All critical processes
are validated to ensure consistency and compliance with specifications.

Manufacturing processes are controlled, and any changes to the process are evaluated.
Changes that have an impact on the quality of the drug are validated as necessary.
Instructions and procedures are written in clear and unambiguous language. ( Good
Documentation Practices)

Operators are trained to carry out and document procedures.

Records are made, manually or by instruments, during manufacture that demonstrate that
all the steps required by the defined procedures and instructions were in fact taken and
that the quantity and quality of the drug was as expected. Deviations are investigated and
documented.
Records of manufacture (including distribution) that enable the complete history of a
batch to be traced are retained in a comprehensible and accessible form.

 The distribution of the drugs minimizes any risk to their quality.

A system is available for recalling any batch of drug from sale or supply.
Complaints about marketed drugs are examined, the causes of quality defects are
investigated, and appropriate measures are taken with respect to the defective drugs and
to prevent recurrence.

INDIAN GMP

INDIAN GMPs

Quality, efficacy and safety of drug have always been a matter of concern for people. Drugs
being a very important component of health care systems need special attention in regard to their
quality, efficacy and safety. A brief review over half a century of drugs scenario in India will
shows us how we have come a long way in controlling of quality of product. The first GMP was
published in june1963.
Thus major contribution of this amendment was introduction of preventive approach to the
control of the drug products. These regulation were first revised in January 1971. A major
revision approached in late 1978.
The current regulation GMP appeared in part 210 of title 21 of code of federal regulations
published by the Food and Drug Administration, Department of Health and Human Services of
USA.
The following are the main objects of GMPs
To produce products confirming to the predetermined specification.
To produce product of consistent quality.
To minimise contamination.
To eliminate error.
Generally text of GMPs provide guidelines on important aspects of manufacture of drugs
like premises, personnel, equipments, sanitation, starting material, manufacturing
operation, validation, quality control system, documentation etc
Many Indian Drug Manufactures are exporting pharmaceutical preparation to developing
countries which are participant to WHO certification scheme.
These countries require a certificate from regulatory agency that the plant in which it
have been manufactured is subjected to inspection at regular intervals and the plant
confirms to requirements for good practices in the manufacture and quality control of
drug as recommended by WHO.
Therefore, Indian drug manufacturers as well as their technical personnel should be
aware of the GMPs prepared by WHO. For convenience, these GMPs have been referred
to as the WHO GMPs.

WHO GMP:
INTRODUCTION AND SIGNIFICANCE

WHO GMP

 The World Health Organisation (WHO) is an agency of United Nation. It is a specialized

agency and its primary responsibilities include international health matter so that the goal
(health) of all can be achieved.
WHO expert committee on specification for pharmaceutical preparation discussed the
text in1968 and the revised text was published as an annexure to its 22 nd report. Text on
GMP was accepted as an integral part of WHO certification scheme on the quality of
pharmaceutical product moving in international commerce by WHA in1969 when it
recommended the first version of scheme. There have been many development since
then. Several nation and international GMPs document have appeared. GMPs text
applicable to the revised text contain three parts:
Part 1 outlines general concepts of quality assurance and salient components of GMPs.
These component of GMPs which includes hygiene, validation, self-inspection,
personnel, premises, equipments, materials and documentation are joint responsibilities
of the top management.
Part 2 provides guidelines on the action to be taken by production and quality control
personnel separately implementing in the general principles quality assurance.
Part 3 is an open ended section and has two supplementary guidelines at present. It is
anticipated that guidelines for special product will be develop in future.

WHO CERTIFICATION SCHEME

The Good Practices in the manufactured control of the drugs (knows as GMPs) form an
integral part of WHO certification scheme.
This scheme envisages that.
1) A comprehensive system of quality assurance should be established on a reliable
system of licensing/registration.

2) An independent analysis of finished product should be carried out.

3) An assurance should obtained through independent inspection that all manufacturing
are carried out in conformity with GMP as laid down by WHO.