Annex 1: Good laboratory practices in governmental drug control laboratories.

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.

eng fre spa.

WHODOC

WHO monograph

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