Continuous Environmental Monitoring Article

By Gill Power

Quality and Compliance - Continuous Environmental Monitoring Article in Pharmaceutical Manufacturing and Packing Sourcer

An article written by our MD, Andy Whittard, was featured in the August 2021 issue of Pharmaceutical Manufacturing and Packing Sourcer.  The article highlights how new regulations for sterile medicinal products, such as the draft revision of the EU GMP Annex 1,  are helping to initiate a push for continuous environment monitoring.

Here’s an extract from the article:

Environmental monitoring (EM) is an established method of reducing the risk of contamination of sterile products, and is used by manufacturers in the pharma and associated healthcare industries in the manufacture of advanced medicinal products, as well as in the specialist food industry.

The importance of EM to maintaining the sterility of medicinal products is reflected in the latest EU GMP Annex 1 draft revision, which calls for continuous EM in sectors with stringent environmental control and which carry a risk to public health upon contamination at manufacturing facilities.

Why do the latest regulations place such as strong emphasis on continuous EM? The short answer is that it is the most effective way to reduce contamination risk.

The article covers:

  • The Benefits of Continuous EM
  • Reducing Long-Term Contamination Risk
  • Transitioning to Continuous EM
  • Important Considerations for a Continuous EM Programme
  • Continuous Air Monitoring Is Crucial for Annex 1 Compliance
  • Target Zero CFU
  • Annex 1 Compliance Puts Manufacturers in a Stronger Position

The article advises that "with the new Annex 1 draft expected to be approved soon, manufacturers of sterile medicinal
products should start evaluating the needs of their business, and planning how to transition to continuous EM as soon as possible. 

With regulations on EM only expected to get tighter, moving to continuous EM and learning how to accurately monitor, report, and counter identified risks is crucial. Not only for compliance with the latest Annex 1 revision, but this can also enable businesses to adapt more rapidly to any future regulatory changes.


This article is taken from Pharmaceutical Manufacturing and Packing Sourcer August 2021, pages 12-15. © Samedan Ltd



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