Procedure for assessing the acceptability, in principle, of pharmaceutical products for purchase by United Nations agencies
1. Introduction:
The World Health Organization (WHO) could provide United Nations agencies with advice on the acceptability, in principle, of pharmaceutical products which are found to meet WHO recommended quality standards, for purchase by such United Nations 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 appropriate (1) and are manufactured in compliance with good manufacturing practices (GMP) (2).
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 manufacturer;
See below PDF for complete details:
WHO TRS (Technical Report Series) 943 Annex 4:
