WHO Expert Committee on Specifications for Pharmaceutical Preparations
Thirty-fifth Report
Technical Report Series, No 885
World Health Organization
ISBN-13    9789241208857 ISBN-10    9241208856
Order Number    11000885 Format    E-book collection (PDF)
Price    CHF    35.00 / US$    42.00 Developing countries:    CHF    24.50
English     1999        162   pages
Table of contents
Related Publications
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Provides a progress report on a number of WHO activities intended to support a comprehensive approach to the quality assurance of pharmaceutical products. Although the report has global relevance, its guidance is of particular importance in countries attempting to establish or strengthen a regulatory framework for 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 brief summary of several ongoing activities coordinated by WHO. These include the continuing development of the International Pharmacopoeia, the establishment of International Chemical Reference Substances and International Infrared Reference Spectra, guidelines for good manufacturing practices, work on the standardization of nomenclature and terminology, and support to countries seeking to establish drug regulatory and legislative systems.
The second and most extensive part consists of nine annexes. The first 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. Revised general guidelines for the establishment, maintenance and distribution of chemical reference substances are issued in line with recent refinements in pharmaceutical and analytical methods, and the continuing need to harmonize the use of comparative standards for pharmaceutical testing and control.
Two subsequent annexes supplement WHO guidelines for good manufacturing practices. The first provides advice on the role, functions, and training of the authorized person, within a manufacturing establishment, responsible for the release of batches of finished products for sale. The second describes good practices for the manufacture of pharmaceutical excipients. Topics covered include self-inspection and quality control, use and cleaning of equipment, quality control of starting materials, and good practices in production and quality control. Additional guidelines cover the inspection of drug distribution channels as a means of ensuring that patients receive quality drugs, and present a framework, consisting of core activities, goals, and areas where national standards are needed, for promoting good pharmacy practices in community and hospital pharmacy settings.
The most extensive guidelines, on national drug regulatory legislation, establish guiding principles for small drug regulatory authorities. General advice on points to consider when drafting national legislation and defining the scope of the marketing authorization procedure is followed by a detailed example of a legislative scheme, including model legislative text and commentary. Intended to assist drug regulators, those drafting legislation, and decision-makers, the guidelines should prove of immediate value to small national drug regulatory authorities with limited human and other resources. 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.