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News about GMP/cGMP

2016-09-13

Annex 17: Responses to the public consultation

Almost one year ago, on 15 September 2015, the European Commission published a comprehensive draft version of Annex 17: Real Time Release Testing (we reported). The seven-page document was open for public consultation until December 2015. All in all 12 responses were received which have now been published on the Commission's website.

 

Here is the list of responses:

It is well worth taking a closer look at the detailed comments and proposed modifications. Various points of criticism are targeted, ranging from the required RTRT Master Plan up to the use of new terminology in vague wording. Taking part in public consultations is an important possibility to narrow down the gap between legal requirements and the possible practical implementation and application of the regulation.

Source:

EC: Good Manufacturing Practices – Major Developments

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