Cherwell has written an article in Pharmaceutical Technology Europe, on why a blended approach to newly revised regulatory guidance to inform environmental monitoring programmes is essential.
Cherwell's Microbiology Product Specialist, Hamish Hogg, has written an article featured in the October 2022 issue of Pharmaceutical Technology Europe magazine. In the article, Hamish highlights how the publication of the new version of the European Union (EU) good manufacturing practice (GMP) Annex 1 guidance, and EN 17141:2020, will now further shape EM programmes when manufacturing sterile medicinal products in the United Kingdom and Europe moving forward.
Here’s an extract from the article:
Individual facilities must work through and interpret the requirements of Annex 1 as best fits them. For example, critical processes and their duration should be defined, such as where product is being manipulated by technicians. This in turn would dictate the combination of monitoring methods utilized and frequency of sampling needed in different areas, with the ability to identify to species level, particularly if there is an organism that can pose a threat to that facility. The new Annex 1 also includes a clause which encourages the consideration of the use of new technologies, such as rapid microbiological methods (RMM) and viable particle counters, if these might better support specific EM needs at a facility.
The article covers:
- What is the purpose of Annex 1 and EN 17141?
- The scope of EM
- Core EM programme requirements
- Right methods for the application
- Sampling vs monitoring
- Passive vs active
- Rapid methods
- Changes to EM
- Continuous air monitoring
- Summary
The article summarises that "Although EU GMP Annex 1 is a key driver to changes in EM programmes in pharmaceutical and sterile medicinal product manufacturing facilities to minimize contamination risk in final product, EU EN 17141 offers important guidance too. Therefore, a blended approach to the review and use of new regulations to inform EM planning and programming is fundamental.
