WHO Expert Committee on Specifications for Pharmaceutical Preparations
Forty-fourth Report
Technical Report Series, No 957
World Health Organization
ISBN-13    9789241209571 ISBN-10    9241209577
Order Number    11000957 Format    Paper Back
Price    CHF    40.00 / US$    48.00 Developing countries:    CHF    28.00
English     2010        287   pages
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Summary
The Expert Committee on Specifications for Pharmaceutical Preparations gives recommendations and provides independent international standards and guidelines in the area of quality assurance for implementation by WHO Member States, international organizations, United Nations agencies, regional and interregional harmonization efforts, as well as WHO's medicines' related programmes and initiatives.

The following new guidelines were adopted and recommended for use in this 44th report: WHO good practices for pharmaceutical quality control laboratories (Annex 1);WHO supplementary guideline for active pharmaceutical ingredients (Annex 2); WHO good manufacturing practices for pharmaceutical products containing hazardous substances (Annex 3); WHO good manufacturing practices for sterile pharmaceutical products (Annex 4); WHO good distribution practices for pharmaceutical products (Annex 5); Guideline on the requalification of prequalified dossiers (Annex 6) and Guideline for the preparation of a contract research organization master file (Annex 7).

In addition, 42 new monographs were adopted for inclusion in The International Pharmacopoeia (Ph.Int.) together with 9 International Chemical Reference Standards (ICRS) for antimalarials, antituberculosis, antiretroviral, radiopharmaceuticals and medicines for children.