New EU GMP Annex 1
Regulatory compliance

The new version of the GMP directives relating to the production of sterile products - EU GMP Annex 1 - published by the EMA on February 19, 2020-version 12, draft still to date, is subject to major modifications which may have significant impacts in terms of organization, quality system change and investments for manufacturers.

This new version notably introduces the concept of global contamination control (Contamination Control Strategy) and asks manufacturers to demonstrate their perfect knowledge and mastery of all the risks of microbiological and particulate contamination inherent in premises, processes, equipment, products ... Manufacturers must compile in an auditable document all the risk analyzes and means of control and control of these risks.

Axys Network, with its network of experts (some having contributed to the comments on the draft of Annex 1) can provide you with support on all the areas covered by Annex 1 (aseptic distribution, freeze-drying, BFS-FFS , Single Use Systems, Barrier Technologies, Utilities, Media Fill Tests, Environmental Controls, Sterilization Methods, Staff Training


 Axys-Network offers 3 products to secure your compliance:

Gap Analysis vs new Annex 1

Gap analysis of all or part of the company's Quality system vs new version of Annex 1; This analysis must lead /

  • on the one hand to the identification of significant deviations between the practices of the site and the evolutions of the new version of appendix 1 through the review of SOP, registration forms, completed documents, review of deviations, qualification reports / validation, analytical data (mainly environment)
  • on the other hand to the proposal of action plan of type training, investments, creation / modification of SOP

    Contamination Control  Stratégy                                     CCS 
This important theme in the new Annex 1 will become an auditable document in the same way as the APR (Annual Product Review) and could be the entry point for inspectors to check the control of microbiological and particulate risks on the site. Axys-Network can support you for:

- Present (recall) the key elements that constitute the CCS - Review all documents / reports / data existing on the site that can be part of this CCS

- Identify those that would be created (and in this case what would be the elements to compile and the strategy to adopt

- Propose a draft (structure) of a global CCS document allowing the site to constitute this document for inspection

In-House Training on Annex 1

It is also possible as part of the mission to train personnel on site in all or part of Annex 1 in addition to the gap analysis

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Inspection ANSM
Non Compliance