
Quality risk management
The new version of Annex 1 of the European GMPs relating to the production of sterile and injectable drugs is largely based on a good mastery of Quality risk management based on the application of ICH Q9 concepts. Axys Network consultants assist you in the implementation of risk management tools throughout the life cycle of your products from the design of a new process or a new production line to the critical investigations inherent in aseptic processes (ie recurrence of non-compliant environmental results, sterility test or non-compliant media fill, etc.) and support you so that you are always ready to successfully pass your next regulatory inspection.
New Line or New Process
The risk analysis of a new production process or a new manufacturing line must allow:
- an exhaustive review of the manufacturing process or line and the identification of the risks inherent in sterility insurance
- identify the critical monitoring parameters and determine the appropriate specifications
- to argue and prioritize validation / qualification efforts according to the risks identified
- to prepare operational procedures for controlling and monitoring risks
- to train staff in particular on the risks identified and their means of control
- Risk analysis methodology to be implemented
- Creation of Risk Register



Support for Investigations
- leading on-site working groups to carry out a detailed process mapping of a workshop, one or more production lines and to identify all risks in terms of sterility insurance
- build the risk matrix and associated CAPA
- develop your contamination control strategy in line with the requirements of Annex 1 of the European GMP
Justifications for environmental control plans
Axys Network brings you its expertise for risk analysis to justify the development or strengthening of an environmental control program for a (new) classified production area or (new) manufacturing line and supports you in establishing your environmental control program