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.
As far as electronic records are controlled, the FDA’s main concern has remained the same
since the introduction of 21CFR11 and that is “to safeguard record integrity in order to
ensure product quality”. Therefore “record integrity and data integrity” is a focus by the
FDA during regulatory audits. So it makes sense to have a robust EMS that can be validated
confirming it meets the requirements of regulatory compliance and that means that
Manufacturing Pharmaceutical companies should be looking closer at their Vendors to
support them in the drive for these continuous process quality improvements.
More and more Pharmaceutical Companies are using Risk Mitigation practices in the
selection of the right Monitoring System provider with the emphasis on strong validation
support on going technical support to reduce down time and potential loss of production
time which may lead to product shortages and loss of revenue. Therefore selection of the
right Vendor is critical as it may impact on Business Continuity. Let’s also look at other
important topics apart from the EMS vendor that must be considered;
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