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News about GMP/cGMP

Annex 6 EU GMP Guideline published

On Febraury 3, 2010 the European Commission published the revised Annex 6 "Manufacture of Medicinal Gases"  of the EU GMP Guideline. The Annex' deadline for comming into operation is Juliy 31, 2010.  

 

The Annex was revised as a consequence of the restructuring of the GMP Guide and the need to modify the requirements of Part II of the Guide for applicability to medicinal gases. There was a need to define more clearly what should be considered as a starting material as opposed to a bulk pharmaceutical product. The opportunity was also been taken to update the annex in general.

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EC/ Annex 6

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