WHO Expert Committee on Specifications for Pharmaceutical Preparations [meeting held in Geneva from 2 to 6 December 1985] : thirtieth report
Loading...
Date
Journal Title
Journal ISSN
Volume Title
Publisher
World Health Organization
World Health Organization
World Health Organization
Abstract
Description
Annex 1: Good laboratory practices in governmental drug control laboratories
50 p.
Describes various projects and activities designed to assist countries seeking to establish basic systems of quality control for imported and domestically produced pharmaceutical products. Main considerations include the selection of appropriate analytical procedures and tests for inclusion in The International Pharmacopoeia, the importance of good laboratory practice in governmental drug control laboratories, and the availability and uses of international chemical reference substances. These general discussions are followed by more detailed information set forth in three annexes. The first presents guidelines for the effective management and operation of governmental drug control laboratories. The scope of these guidelines ranges from matters of organizational structure and staffing to advice on routines and management, documentation requirements, and the evaluation of test results. The second annex features a list of available international chemical reference substances, together with information on ordering and supply. The final anne sets out a detailed model syllabus for the group training of recent science and pharmacy graduates in drug quality control
50 p.
Describes various projects and activities designed to assist countries seeking to establish basic systems of quality control for imported and domestically produced pharmaceutical products. Main considerations include the selection of appropriate analytical procedures and tests for inclusion in The International Pharmacopoeia, the importance of good laboratory practice in governmental drug control laboratories, and the availability and uses of international chemical reference substances. These general discussions are followed by more detailed information set forth in three annexes. The first presents guidelines for the effective management and operation of governmental drug control laboratories. The scope of these guidelines ranges from matters of organizational structure and staffing to advice on routines and management, documentation requirements, and the evaluation of test results. The second annex features a list of available international chemical reference substances, together with information on ordering and supply. The final anne sets out a detailed model syllabus for the group training of recent science and pharmacy graduates in drug quality control