HOW TO MINIMISE THE RISK OF FALSE POSITIVES IN EM UNDER THE NEW ANNEX 1

The primary objective of Good Manufacturing Practice (EU GMP) is to ensure finished product is free of microbial contamination, particulates and is pyrogen free. The new revised Annex 1 places greater emphasis on the use of a Quality Risk Management (QRM) approach for identifying, evaluating, and controlling the risks within a manufacturing facility and to continually develop that holistic, facility wide contamination control strategy (CCS).

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