Dünya Sağlık Örgütü (DSÖ-WHO)’nden İyi Medikal Uygulamalar revizyonu önerisi (İng)
WHO Proposes revision to GMP Annex 3.
The WHO has published a proposed updated text for “WHO GMP for pharmaceutical products: main principles”, in January 2013. The main principles are published as Annex 3 in the WHO Technical Report Series, No. 961. During 2012 the Secretariat was made aware that the current good manufacturing practices (GMP) for pharmaceutical products: main principles published as Annex 3 in the WHO Technical Report Series, No. 961, 2011, would need updating. ( (Quality assurance of pharmaceuticals: a compendium of guidelines and related materials).
The WHO Expert Committee on Specifications for Pharmaceutical Preparations discussed the need for an update during its forty-seventh meeting and agreed to pursue this accordingly. Attached please find a table with the current and newly proposed text. The paragraphs that would need to be updated have been identified as being in the following sections:
- Section 1 (pharmaceutical quality system)
- Section 2 (GMP for pharmaceutical products)
- Section 7 (contract production and analysis) and
- Section 17 (good practices in quality control).
Comments on the proposal will be accepted until 29 March 2013, a working document is available electronically. A presentation of the document is planned on the 48th Meeting of the WHO Expert Committee on Specifications for Pharmaceutical Preparations in October 2013.