Raising the bar for continuous environmental monitoring
By Gill Power
Cleanroom Technology - November 2018
Cherwell Laboratories is featured in an article in the November 2018 issue of Cleanroom Technology magazine. In the article, Cherwell’s Managing Director, Andy Whittard, explains how the recently published draft of the new EU GMP Annex 1: Manufacture of Sterile Medicinal Products, raises the bar for continuous environmental monitoring.
The piece in The November issue covers: The Best Line of Defence; Preparing for Annex 1 Compliance - focusing on EM audit; Understand the utilities chapter; Analyse your current EM in-depth; Active and passive EM options, and Tools for Effective Continuous EM and can be found on pages 15 and 16 of the November issue of Cleanroom Technology or on the Cleanroom Technology website.
Here’s an extract from the article: While a continuous monitoring programme is not a legal requirement in these industries, the latest revision of Annex 1 underlines the importance of risk reduction; continuous monitoring is the best way to achieve this. Contamination can carry serious consequences for both the business and the public, as recent high-profile cases confirm. Even if a contamination is contained, it can still cause damage to the manufacturer in lost revenue and dented reputation. The more stringent standards on the horizon call for a stricter environmental monitoring protocol. This means rethinking your best line of defence in advance...
The final word on the article is:
Most importantly in light of the new draft Annex 1, regulated businesses should not do nothing. Once the draft is approved, if you have not already ensured your environmental monitoring is up to scratch, you will be running to catch up. Particularly, when regular reviews of your new EM programme will be key to ensuring your processes are providing the information needed to direct and motivate appropriate measures to counter any risk. And, regulations are likely to only get tighter.
The Environmental Monitoring Processes and Validation Guide
Understand the key changes and challenges of the EU GMP Annex 1 draft revision.
What will it mean for your environmental monitoring processes?