WHO Expert Committee on Specifications for Pharmaceutical Preparations - WHO Technical Report Series, No. 908 - Thirty-seventh Report
(2003; 148 pages) View the PDF document
Table of Contents
View the documentWHO Expert Committee on Specifications for Pharmaceutical Preparations
View the document1. Introduction
Open this folder and view contents2. General policy
Open this folder and view contents3. Quality control - specifications and tests
View the document4. Quality control - international reference materials
Open this folder and view contents5. Quality control - national laboratories
Close this folder6. Quality assurance - good manufacturing practices
View the document6.1 Specific GMP guidelines for radiopharmaceutical products
View the document6.2 GMP guidelines for active pharmaceutical ingredients
View the document6.3 WHO GMP: main principles for pharmaceutical products
View the document6.4 WHO basic training modules on GMP
Open this folder and view contents7. Quality assurance - inspection
Open this folder and view contents8. Quality assurance - distribution and trade-related
Open this folder and view contents9. Quality assurance - risk analysis
Open this folder and view contents10. Quality assurance - drug supply
Open this folder and view contents11. Quality assurance - storage
View the document12. International Nonproprietary Names (INNs) programme
Open this folder and view contents13. Miscellaneous
View the documentAcknowledgements
View the documentReferences
View the documentAnnex 1 Recommendations on risk of transmitting animal spongiform encephalopathy agents via medicinal products
View the documentAnnex 2 The International Pharmacopoeia: revised concepts and future perspectives
Open this folder and view contentsAnnex 3 Guidelines on Good Manufacturing Practices for radiopharmaceutical products
Open this folder and view contentsAnnex 4 Good Manufacturing Practices for pharmaceutical products: main principles
View the documentAnnex 5 Model certificate of Good Manufacturing Practices
View the documentAnnex 6 Guidance on Good Manufacturing Practices (GMP): inspection report
View the documentAnnex 7 Application of Hazard Analysis and Critical Control Point (HACCP) methodology to pharmaceuticals
Open this folder and view contentsAnnex 8 Procedure for assessing the acceptability, in principle, of pharmaceutical products for purchase by United Nations agencies
Open this folder and view contentsAnnex 9 Guide to good storage practices for pharmaceuticals1
View the documentBack cover
 

6.3 WHO GMP: main principles for pharmaceutical products

The Committee was informed of the main changes that had been made in revising these GMP guidelines, to incorporate texts and recommendations published separately, and to bring the guidelines into line with current GMP requirements, particularly in relation to validation, authorized persons, documentation and definitions. Consultations in December 2000 and August 2001 had been arranged to consider comments made by interested parties. During these consultations, all comments received were carefully examined.

The Committee discussed the difficulty of implementing cleaning validation in some countries and the apparent lack of guidelines on this subject to assist GMP inspectors. Examples of guidelines currently available were brought to the attention of the Committee. It was recommended that WHO should start work soon on the preparation of additional guidance documents for key areas of GMP such as validation and aerosol manufacture.

The Committee adopted the revised guidelines “Good Manufacturing Practices for pharmaceutical products: main principles” (Annex 4) and noted that they should be discussed at the next meeting of the Expert Committee to take account of any comments made in the interim.

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