Who Expert Committee on Specifications for Pharmaceutical Preparations

In the area of quality control, the Expert Committee reviewed new and revised specifications and general texts for inclusion in The International Pharmacopoeia, and received the annual report of the European Directorate for the Quality of Medicines and HealthCare, the custodian center for International Chemical Reference Substances (ICRS). The Committee adopted a number of monographs, general texts and ICRS. It noted the report on Phase 5 of the External Quality Assurance Assessment Scheme and on new approaches to ensure sustainability of this scheme through user fees. The Committee further received a concept paper on the benefits of good pharmacopoeial practices (GPhP), and was informed of progress achieved with developing a comprehensive document on GPhP. It adopted eight guidelines and 16 technical supplements, including a new guidance text on good review practice prepared under the leadership of the Asian-Pacific Economic Cooperation Regulatory Harmonization Steering Committee. The Committee took note of ongoing work to promote collaboration and information exchange through the good regulatory practice project and welcomed the development of a comprehensive set of guidelines for all national regulatory authorities through this project.