This category addresses environmental control and monitoring practices used to assess and maintain controlled conditions in GMP facilities. It covers viable and non-viable monitoring, performance qualification, limits, trending, and ongoing review.
Purpose and Scope Environmental control and environmental monitoring are complementary parts of a lifecycle contamination-control framework. Environmental control uses facility design, HVAC performance, cleaning and disinfection, material and personnel practices, process controls, and operational discipline to prevent or reduce contamination….
Purpose and Scope Environmental performance qualification establishes documented evidence that a controlled environment can maintain required conditions during defined operating states and representative activities. The resulting data helps characterize normal performance, identify sensitive locations, and establish the basis for routine…
Purpose and Scope An environmental monitoring program defines how environmental conditions are sampled, documented, reviewed, investigated, trended, and used to maintain control during GMP operations. Effective monitoring requires more than collecting samples at established intervals. The program must be scientifically…