Wednesday, 8 April 2020

EU GMP Annex 1 - The new draft and implications for sterile product manufacturers

EU GMP Annex 1 is the primary document governing the manufacture, control and release of sterile pharmaceutical products (both terminally sterilised and aseptically filled medicines). The Annex will shortly undergo a comprehensive update, as signalled by a new draft issued in February 2020. This white paper assesses many of the key points within the draft, focusing on those areas that have a direct impact upon sterile product manufacturing.

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

This white paper provides an overview of the draft Annex 1 and considers the focal points for sterile products manufacture, control and release.

To access go to: Annex 1

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (

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