Cleanroom Environmental Monitoring Systems, Regulatory compliance and Risk Mitigation
With the never ending shift towards continuous quality improvements within the manufacturing of pharmaceutical products it is worth looking at the current requirement of GMP and also 21CFR11 in the context of GAMP 5 requirements. How a Company creates, maintains, retrieves, corrects and controls data can affect product quality. How a company reacts to out of tolerance conditions via continuous Environmental Monitoring Systems (EMS) alarm notification is crucial to the process operation and the product quality. Therefore the EMS becomes a critical process tool to ensure product quality and the data itself.