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  • New upcoming changes of the EU GMP Annex 1

    How to face the new challenges?

    (Focus on clean rooms & pharmaceutical water/gas systems)

    On 20th December 2017, the European Commission published a revised draft of Annex 1 "Manufacture of Sterile Medicinal Products" in connection with the EU GMP Guideline. The revised Annex 1 is a completely new document which will impact and challenge the current procedure for managing and qualifying clean rooms i.e. controlled environments, in addition to water- and /gas GMP systems, via introduction of a risk based approach at all levels.The Webinar will focus on what has been changed in Annex 1 and how to deal with such changes. There will also be specific topics focused on clean rooms and pharmaceutical water/gas systems. Eurofins BPT´s technical expert will discuss the rationale behind the new Annex 1, and go through “real life” examples and strategies to deal with the new changes and challenges.

    The main topics for the webinar:

  • Comparison: Old vs the New Annex 1. The rationale behind the changes.

  • Quality Risk Management and how this new umbrella is now an expectation.

  • What´s new for clean-rooms i.e. controlled environments, management? Strategies and related good practices under the risk based umbrella.

  • What´s new for the management of water and gas systems? Strategies and related good practices under the risk based umbrella.

  • Roundup of strategies: there are several strategies that can be implemented to cope with the modification of the annex 1, I´ll be discussing PROs and CONs of each one.                                           

Webinar video