Tuesday 30 June 2020

Holistic contamination control is central to revised EU GMP Annex 1

The main focal points from the 2020 draft of EU GMP Annex 1 (titled “Manufacture of Sterile Products”) signal to sterile products manufacturers a shift in regulatory thinking towards environmental controls rather than an over-reliance upon monitoring; with risk-based scientific thinking; and looking at contamination control holistically. The main themes are:

  • The expectation for each facility to have in place a formal, holistic contamination control strategy, focused on minimizing contamination control with respect to sterile manufacturing.
  • Additional requirements for cleanroom classification (beyond ISO 14644 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.

In relation to this, Tim Sandle has written an article. The reference is:

Sandle, T. (2020) 2020 Annex 1 Draft: Holistic Changes, Cleanroom Technology, 28 (5): 25-27

This article looks into some of the likely changes that will impact sterile products manufacturers, which can help organisations to stay ahead of the regulatory curve.

For details, please contact Tim Sandle

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)

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