The various GMP guidelines and International ISO standards around GMP cleanrooms are complex and often appear to give conflicting advice, leading to confusion and sometimes incorrect interpretation. In the case of Routine Environmental Monitoring, there is very little prescriptive advice and the onus is on the cleanroom owner to devise an appropriate monitoring plan and, in the frequently prescriptive GMP industry, the lack of direct guidance leaves users struggling to know what to do and the temptation is to either create over-burdensome monitoring programs or to try to simply use the same monitoring plan as is used for classification. This paper discusses the differences between GMP Cleanroom Classification and Routine Environmental Monitoring and explains how Beckman Coulter can help.
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