WHO Expert Committee on Specifications for Pharmaceutical Preparations: Forty-fourth Report (WHO Technical Report Series)

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 programs 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.