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News about GMP/cGMP

EU GMP: Annex 6+13 come into operation

The European Commission has published the revised annexes 6 and 13 of the EU GMP Guideline some months ago. They come into operation on  July 31, 2010.


Annex 6: Manufacture of Medicinal Gases

Changes/ News:

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.

Annex 13: Manufacture of Investigational Medicinal Products

Changes/ News:

  • Revision to reinforce the principle of independence between production and quality control functions in cases where the number
  • of personnel involved is small.
  • Changes to sections 36 and 37 to supplement, for investigational medicinal products, the guidance for reference and retention samples
  • given in Annex 19.
  • An additional note has been introduced to clarify the meaning of “reconstitution” as referred to in article 9.2 of Directive 2005/28/EC.
  • The content of the Batch Certificate referred to in Art. 13(3) of Directive 2001/20/EC, agreed following a separate public
  • consultation, has been added as an attachment.

Check the changes made by the European Commission.


EC/ Annex 6

EC/ Annex 13

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