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WHO good manufacturing practices for sterile pharmaceutical products
Introduction:
The WHO Expert Committee on Specifications for Pharmaceutical Preparations in its thirty-sixth report in 1999 adopted WHO good manufacturing practices for sterile pharmaceutical products (WHO Technical Report Series, No. 902, 2002, Annex 6) (http://whqlibdoc.who.int/trs/WHO_TRS_902.pdf); and published in: Quality assurance of pharmaceuticals. A compendium of guidelines and related materials. Vol. 2. 2nd updated ed. Good manufacturing practices and inspection (2007) (1).
Following implementation of these WHO good manufacturing practices (GMP) within the context of the WHO Prequalification Programme, a proposal for revision is being submitted to take into consideration new developments. The proposal for revision of the above-mentioned guidance is being made to bring the WHO GMP into line with International Standardization Organization standard ISO 14644-1 (2) and recent practices of the United States (3), Japan (4), the European Union (5) and the Pharmaceutical Inspection Co-operation Scheme.
- New chapters on Isolator technology and Blow/fi ll/seal technology have been added to the document.
- The chapter on Finishing of sterile products has been amended and provisions have been given for capping of vials.
- The chapter entitled Manufacture of sterile preparations has been amended and provisions have been given for clean room and clean-air device monitoring.
Implementation of these new practices may need to be undertaken for certain parts using a step-wise approach, especially the part relating to the provision for capping in a clean or sterile environment, as this is currently not implemented in most industries.
On the basis of the above, the following text is proposed to replace the previously published guidance.
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Table of contents
WHO TRS (Technical Report Series) 957, 2010 Annex 4:
