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How to conduct product quality review in pharmaceutical

GMPSOP

Additional documents included each month. Trending will help identify product and process improvements. If significant trends are identified, they should be documented, and changes should be made to avoid out-of-specification results. The number of batches manufactured, released and rejected should be documented.

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Corrective and Preventive Action (CAPA) Procedure for GMP

GMPSOP

Additional documents included each month. Corrective and preventive actions are identified and implemented as the outcome of investigations such as deviations, product complaints, internal audit observations, risk assessments, stability failure, or other process or system-related non-conformances. Checkout sample preview s.