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EU: Responses to the public consultation on the revision of Annex 15
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News about GMP/cGMP

2015-05-25

EU: Responses to the public consultation on the revision of Annex 15

The European Commission has published the responses to the public consultation on the revision of Annex 15: Qualification and Validation.

 

The final version of Annex 15 was already published in March 2015. Now the Commission has published 35 comments from regulators, industry and associations.

Although the single comments may be of interest, especially the views of the regulators, it would be more interesting if the Commission would publish a matrix that reflects what they have done with the comments (e.g. accepted, not accepted and why not).

Source:

EU Commission:Good Manufacturing Practices - Major developments

 

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