WHO Updating Sterile Processing Guide to Align with US, EU, and Japan

The World Health Organization (WHO) is updating its Annex 4 “Good Manufacturing Practices for Sterile Pharmaceutical Products,” replacing its 1999 version of that document to align with more recent guidance issued by the three ICH regions.

The proposal for revision is being made to bring the WHO GMP into line with ISO 14644-1 and the current guidelines from the US, Japan and EU (FDA’s 2004 guidance on sterile drug products, PMA’s 2005 aseptic processing guidance, EU’s 2008 revision of Chapter 4 Annex 1), and from the Pharmaceutical Inspection Co-operation Scheme (PIC/S).

The announcement follows the forty-fourth meeting of the WHO Expert Committee on Specifications for Pharmaceutical Preparations in Geneva in October 2009.  The committee meets annually and their Technical Report Series (TRS), which includes discussion from the meeting and all adopted guidelines in the form of annexes, is published some months later.  The 2010 document is titled TRS 957 and includes the updated Annex 4.

An analysis of the changes in  Annex 4 is provided for subscribers on page 2, along with links to the relevant documents.


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