WHO Expert Committee on Specifications for Pharmaceutical Preparations

This report 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 are included in the report: development of monographs for The International Pharmacopoeia; WHO good manufacturing practices: water for pharmaceutical use; Pharmaceutical development of multisource (generic) pharmaceutical products; Guideline on submission of documentation for a multisource (generic) finished pharmaceutical product for the WHO Prequalification of Medicines Program: quality part; Development of paediatric medicines: points to consider in formulation; Recommendations for quality requirements when artemisinin is used as a starting material in the production of antimalarial active pharmaceutical ingredients.

In addition, 18 new monographs and general test methods were adopted for inclusion in The International Pharmacopoeia. The specifications under development are internationally applicable methods for testing antimalarial, antituberculosis, antiretroviral and radiopharmaceutical medicines, as well as medicines for children.