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
Open this folder and view contents6. Quality assurance - good manufacturing practices
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
Close this folderAnnex 8 Procedure for assessing the acceptability, in principle, of pharmaceutical products for purchase by United Nations agencies
View the document1. Introduction
Open this folder and view contents2. Steps of the procedure
View the documentAppendix Provisions for evaluators of product dossiers and for inspectors (team member participating in site visits) within the scope of the quality assessment procedure of pharmaceutical products
View the documentReferences
Open this folder and view contentsAnnex 9 Guide to good storage practices for pharmaceuticals1
View the documentBack cover
 

1. Introduction

The World Health Organization (WHO) could provide United Nations agencies advice on the acceptability, in principle, of pharmaceutical products which are found to meet WHO recommended quality standards, for purchase by such UN agencies. This will be done through a standardized quality assessment procedure.

The purpose of the quality assessment procedure is to evaluate whether the pharmaceutical products meet the requirements recommended by WHO for multisource (generic) pharmaceutical products as appropriatei and are manufactured in compliance with Good Manufacturing Practices (GMP)ii.

The quality assessment procedure established by WHO is based on the following principles:

- Reliance on the information supplied by the National Drug Regulatory Authority (DRA);

- General understanding of the production and quality control activities of the manufacturers;

- Evaluation of product information submitted by manufacturers including product formulation, manufacture and test data and results;

- Assessment of consistency in production and quality control through compliance with GMP;

- Random sampling and testing of drugs supplied;

- Distribution of products;

- Handling of complaints and recalls;

- Monitoring of complaints from agencies and countries1.

1 The guiding principles are based on the report (Annex 8) adopted by the 37th WHO Expert Committee on Specifications for Pharmaceutical Preparations meeting held in Geneva 22 - 26 October 2001 (forthcoming).


WHO could also collaborate with DRAs in the quality assessment. WHO recommends that manufacturers expressing interest to supply drugs through the UN agencies inform the DRAs of their intention and request the DRA to collaborate with WHO in the quality assessment process. It is recommended that the manufacturers provide the DRA with the necessary authorization to discuss the relevant product files with WHO representatives during inspections where relevant or required (subject to appropriate confidentiality provisions, if necessary.

WHO will advise UN agencies of the manufacturers whose products have been found acceptable in principle for procurement through a procedure of quality assessment based on WHO recommended guidelines and standards.

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