Tim Sandle has authored a white paper on this subject:
Sandle, T. (2020) EU GMP Annex 1 - The new draft and implications for sterile product manufacturers, White Paper 1, Reading Scientific Services Ltd, UK
The key takeaways from the latest draft are:
• The expectation for each facility to have in place a formal, holistic contamination control strategy, focused on minimising contamination control with respect to sterile manufacturing
• Additional requirements for cleanroom classification (beyond ISO requirements)
• A major focus on risk-based approaches
• Recommendations for the wider use of barrier technology
• A strong focus on personnel controls, such as gowning, and training
To access go to: Annex 1
Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)
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