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On 12 October 2015, the European Commission published revised version of Annex 16: Certification by a Qualified Person and Batch Release of the EU GMP Guide. The new annex will become effective on 15 April 2016. General principles Revised version of the annex states that: The ultimate responsibility for the performance of a medicinal product over its
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Revision of the EU GMP Guide – Annex 17 (Part I)

  • 14 October 2015
  • Annex 17, GMP, parametric release, PAT, pharmaceutical development, QbD, QRM, RTRT,
On 15 September 2015, the European Commission released for public consultation (until 11 December 2015) a draft revised version of Annex 17: Real Time Release Testing of the EU GMP Guide. Comparing to current version of this annex, an application of the concept, which under specific circumstances, and where authorised, allows batch release based on information
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