Tuesday 28 September 2021

Quality risk management for cleanrooms


To be effective, microbiological environmental monitoring of cleanrooms needs to be risk-based. This not only delivers an effective programme, Dr. Tim Sandle finds, it also meets the regulatory expectation presented in the revised EU GMP Annex 1 and hence risk assessments are needed to build a compliant monitoring regime.


Developing well-designed environmental monitoring programmes requires an understanding the risks, contamination sources, strategies to reduce risks. This necessary in order for determining frequencies of monitoring, assessing suitable monitoring locations, and for understanding the significance of contamination events, should they occur.  With any established environmental monitoring programme it is important to review this programme regularly and to update or adapt the regime according to process changes, room design, shift changes, cleaning and disinfection levels, and to set and evaluate corrective and preventative actions put in place to address contamination events.



Sandle, T. (2021) Quality risk management leads to more effective environmental monitoring, European Pharmaceutical Review, Environmental Monitoring Supplement (Important considerations for every bio-pharmaceutical microbiology QC lab), June 2021: 9-12




Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)

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