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 raises the bar for continuous environmental monitoring.
The piece covers: The Best Line of Defence; Preparing for Annex 1 Compliance 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...
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