Roadmap to Compliance: How the New EU GMP Annex 1 (Draft 2020) May Impact Your Aseptic Manufacturing
This webinar provides an overview of a holistic approach to achieve compliance with good manufacturing practice (GMP) requirements for environmental monitoring (EM) in aseptic manufacturing areas, such as ISO 5 cleanrooms in a traditional setup, RABS, or isolators. The new EU GMP Annex 1 (Draft 2020) requires EM programmes and procedures based on risk analysis.
This includes the establishment of:
- sampling plans
- qualification and validation of methods for EM
- data analysis
- traceable and complete documentation
All single steps should be traceable and fulfill ALCOA principles. CFR 21 Part 11-compliant software solutions and validated hardware and culture media will help you improve your aseptic manufacturing quality. Watch this webinar and learn about the data cycle that allows trending and predictive workflows on examples of use cases.