WHO Expert Committee on Specifications for Pharmaceutical Preparations : Thirty-fifth Report - 35th Report

A progress report on a number of WHO activities intended to support a comprehensive approach to the quality assurance of pharmaceutical products.

All recommendations share the ultimate goal of helping regulatory authorities safeguard the health of patients by protecting them from substandard or counterfeit products.

The report has two parts. The first provides a summary of several ongoing activities co-ordinated by WHO.

These include the continuing development of the "International Pharmacopoeia", the establishment of International Chemical Reference Substances and International Infrared Reference Spectra, and guidelines for good manufacturing practices.

The second part consists of nine annexes. The fist two provide updated lists of available International Chemical Reference Substances and International Infrared Reference Spectra.

The remaining annexes set out international guidelines and recommendations covering a range of activities central to the quality control and regulation of pharmaceutical products.

Two subsequent annexes supplement WHO guidelines for good manufacturing practices.

Also included is a provisional legislative scheme for the registration of pharmacy personnel. The report concludes with provisional guidelines for developing training programmes for the inspection and examination of counterfeit pharmaceuticals.