WHO Expert Committee on Specifications for Pharmaceutical Preparations
Forty-eighth Meeting Report
Technical Report Series, No 986
World Health Organization
ISBN-13    9789241209861 ISBN-10    9241209860
Order Number    11000986 Format    Paper Back
Price    CHF    50.00 / US$    60.00 Developing countries:    CHF    35.00
English     2014        398   pages
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Summary
The Expert Committee on Specifications for Pharmaceutical Preparations works towards clear, independent and practical standards and guidelines for the quality assurance of medicines. Standards are developed by the Committee through worldwide consultation and an international consensus-building process.

The following new guidelines were adopted and recommended for use, in addition to 20 monographs and general texts for inclusion in The International Pharmacopoeia and 11 new International Chemical Reference Substances. The International Pharmacopoeia - updating mechanism for the section on radiopharmaceuticals; WHO good manufacturing practices for pharmaceutical products: main principles; Model quality assurance system for procurement agencies; Assessment tool based on the model quality assurance system for procurement agencies: aide-memoire for inspection; Guidelines on submission of documentation for prequalification of finished pharmaceutical products approved by stringent regulatory authorities; and Guidelines on submission of documentation for a multisource (generic) finished pharmaceutical product: quality part.