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News about GMP/cGMP
EU GMP: Annex 6+13 come into operation
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.
Outcome:
Check the changes made by the European Commission.
Source:
EC/ Annex 6
EC/ Annex 13