The final version of “EU GMP Annex 1 – Manufacturing of sterile medicinal products” was released last August 2022 – thus making the draft released in February 2020 official – including a new chapter on viable and non-viable environmental and process monitoring.
The GMP guidelines that regulate the production of sterile medicines recall the principles of Quality Risk Management and the need to build a holistic document that indicates the level of compliance of the productions in the plant and Contamination Control Strategy (CCS).
The necessary changes are important and significant. The adaptation to EU GMP Annex 1 therefore requires a practical and operational approach that can be implemented with the support of Rigel Life Sciences’ experts who bring their knowledge and experience through training courses organized at our customers’ HQ or online,focused on Viable and Total Particle Environmental Monitoring aspects.
Rigel Life Sciences training courses adapt to any program or location to support you every step of the way, whether it regards compliance consultancy, set up a new process or employee training.
Course Contents:
- Introduction to the Regulatory Framework
- Cleanroom and Clean Air Equipment Qualification
- Environmental & Process Monitoring
- New management methodology for Grade A Macroparticles (> 5µm)
- Trends and Reports
- Viable/ Microbial Air Monitoring
Benefits:
Our participants will be able to understand the new EU GMP Annex 1 Guide and its impact on future aseptic processing, receiving pragmatic recommendations for the creation and implementation of environmental monitoring programmes and new insights on how to improve their cleanroom and contamination control strategy.
