(2003; 148 pages)
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.