Europe

EU GMP Annex 1: The annex came into force at the start of March 2009. Requirements for the capping of vials will need to be implemented by the specified date of 1st March 2010.

A concept paper on revisions to the GDP guidelines has been published. Click here to read it.

The EU Quality Working Party has published questions and answers regarding endotoxin and sterility testing at the end of shelf life on the EMEA website. Click here for details.

A concept paper on proposals for implementation of ICH Q10 (pharmaceutical quality systems) in the EU has been published. Click here to read it.

USA

FDA representatives to speak at GMP conference in Shanghai: FDA's Friedman and Uratani will speak at the PDA/FDA Asia-Pacific Pharmaceutical Ingredient Supply Chain Conference in Shanghai, China (June 15-17, 2009)

Global

WHO publishes its sterile manufacturing guidance draft: Whereas previous WHO documents have tended to mirror EU documents, the newly-published WHO sterile products draft guidance moves significantly away from EU GMP Annex 1, aligning itself much more with the US philosophy in a number of areas. Most significantly, monitoring for 5 micron particles is not required.