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News about GMP/cGMP

EU-GMP: Annex 14 in Operation

The revised Annex 14 of the EU GPM Guide is comming into operation on November 30, 2011.

 

Annex 14 "Manufacture of Medicinal Products Derived from Human Blood or Plasma" was published in May 2011 after an extensive revision.

The annex was revised due to the development of standards concerning quality and safety for the collection and testing of human blood and blood components for all uses, including the manufacture of medicinal products.

Outcome:

Make sure you are well prepared, when the revised annex 14 is comming into operation on November 30, 2011. The EC has published the annex online.

Source:

EC/ Annex 16

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