Wednesday, 7 March 2018

Annex 1 calls for a contamination control strategy

A new draft of the European Union (EU) Guidelines to Good Manufacturing Practice (GMP) Annex 1, for sterile medicinal products manufacture, has been issued for public comment. The draft calls on each pharmaceutical manufacturing facility to have a holistic contamination control strategy in place. The points for inclusion in such a strategy are alluded to in the draft; this article draws these points out and provides some examples of what should be included. This may prove to be a useful framework for GMP facilities to review their practices against.

Tim Sandle has written an article for GMP Review on one of the main elements of the new draft guidance for sterile drugs manufacturers, from the European Commission.

The reference is:

Sandle, T. (2018) Annex 1 calls for a contamination control strategy, GMP Review, 16 (3): 4-7

For further details please contact Tim Sandle

Posted by Dr. Tim Sandle

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