Article - The Impact of Annex 1 on Environmental Monitoring

By Gill Power

Compliance Monitoring - EM Article in Cleanroom Technology Magazine

An article written by our MD, Andy Whittard, has been featured in the November 2021 issue of Cleanroom Technology magazine. The article highlights the focus placed on the detail and specific wording in the draft revision of EU GMP Annex 1, in particular, regarding to environmental monitoring. It is anticipated that the revised Annex 1 document will be released in January 2022.

Here are extracts from the article:

“The much-discussed revision of the EU GMP Annex 1 is hopefully nearing conclusion with the release of the document anticipated in early January 2022. A lot of focus has been placed on the detail and specific wording within this key document and environmental monitoring is a key part…

The all-important Annex 1, as part of EU GMP, applies to the manufacture of sterile products and its purpose is to ‘prevent microbial, particulate and pyrogen contamination in final product’…

The latest EU GMP Annex 1 draft revision calls for continuous EM in sectors with stringent environmental control and which carry a risk to public health should the manufacturing be contaminated. Continuous EM is the most effective way of reducing contamination risk, which is why these latest regulations now place such a strong emphasis on its more widespread use.”

The article covers:

  • Continuous EM in Annex 1
  • Moving to continuous
  • A holistic programme
  • The importance of continuous
  • Aiming for zero
  • Stepping towards a global standard

The article advises that “Another key factor in the importance of the new EU GMP Annex 1 revision is the fact that it will also be used by the Pharmaceutical Inspection Co-operation Scheme (PIC/S). the WHO, as well as EU GMP. This revision really represents an important step towards a truly global standard in cleanroom environments.”

The article can be found on pages 21, 22 and 24 of the November 2021 issue of Cleanroom Technology.

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