WHO Good Manufacturing Practices (GMP) For Pharmaceutical Products: Main Principles
Introduction:
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 Twenty first 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 twenty-second 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 first version of the WHO Certification Scheme on the quality of pharmaceutical products moving in international commerce in resolution WHA22.50, it accepted at 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 adopted in 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;
– Starting materials for use in dosage forms, when they are subject to control by legislation in both the exporting Member State and the importing Member State;
– Information on safety and efficacy (resolution WHA41.18, 1988).
In 1992, the revised draft requirements for GMP were presented in three parts, of which only parts 1 and 2 are reproduced in this document (1). “Quality management in the medicines industry: philosophy and essential elements”, outlines the general concepts of Quality Assurance (QA) as well as the principal components or subsystems of GMP, which are joint responsibilities of top management and of production and quality control management. These include hygiene, validation, self-inspection, personnel, premises, equipment, materials and documentation.
“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.
These two parts were subsequently supplemented by further guidelines which are integral parts of these GMP for pharmaceutical products. All these texts are available on the Medicines web page (http.www.who.int/medicines/organization/qsm/activities/qualityassurance/gmp/gmpcover. html).
Considerable developments in GMP have taken place in the intervening years, and important national and international documents, including new revisions, have appeared (2–5). Thus there is a necessity to revise the main principles and incorporate the concept of validation.
Among other items of feedback discussed during the consultation on WHO guidelines for medicines quality assurance, Quality Control (QC) laboratories and transfer of technology on 27–31 July 2009, the need was identified to incorporate a new section on “Product quality review” under Chapter 1: “Quality assurance”.
In addition, several updates were suggested to further enhance the guidelines. These included the concept of risk management, replacing “drugs” by the term “medicines” and introducing the concept of a “quality unit”.
During 2012 the Secretariat was made aware that the current Good Manufacturing Practices (GMP) for pharmaceutical products: main principles, published as Annex 3 in the WHO Technical Report Series, No. 961, 2011, would need updating (http://www.who.int/medicines/areas/quality_safety/quality_assurance/production/en/index.html − Quality assurance of pharmaceuticals: a compendium of guidelines and related materials).
The WHO Expert Committee on Specifications for Pharmaceutical Preparations discussed the need for an update during its forty-seventh meeting and agreed to pursue the matter accordingly.
The following sections were updated in the newly revised version and, after the usual consultation process, were presented to the forty-eighth Expert Committee for adoption:
Section: Pharmaceutical quality system
Section 2: 2. Good manufacturing practices for pharmaceutical products
Section 7: Contract production, analysis and other activities
Section 17: 17. Good practices in quality control
WHO Good Manufacturing Practices For Pharmaceutical Products: Main Principles
(Annex 2, WHO Technical Report Series 986, 2014)
