Pharmaceutical Deviation Management Case Study

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Pharmaceutical Deviation Management and CAPA is a Important part of GMP guidelines of all Countries for Industries. Deviation is generally defined by departure from the standard operation procedure and CAPA is generally defines by Correction, Corrective Action, Prevention and Preventive Action. Deviation also defines Out of specification also. The brief Details of Deviation Management and CAPA are described here. Keywords: Deviation, Out of Specification, Pharmaceutical Inspection Conventions, Good Manufacturing practice, CAPA, 21 CFR (Code of Federal Regulations) Deviation Management[1,2] Introduction A deviation is an unusual or ‘abnormal’ event. Formally defined as a departure from an approved instruction or established standard (PIC/S Guide to GMP PE009-8, Pt II and USP ). It can be planned or unplanned. Deviation-Planned…show more content…
Treatment phase Based on the category into which the event has been placed, actions are taken as follows: • Incident: If the event is classed as an “Incident” it is closed, as the actions required to resolve it are described. • Non-critical deviation: The process deviation database is consulted to see how many times it has happened. If the specified maximum number of repeats allowed has not been exceeded, the event stays in the “Non-critical deviation” category. The appropriate corrective measures are then applied and the deviation is closed as an isolated occurrence. This event is then entered in the process deviation database, to feed into and update the general FMEA for the process. • Critical deviation: The event is placed in this category: • When the answers given in the decision tree point to a “Critical deviation”; • If it was first classified as “Non-critical”, but has exceeded the maximum number of repeats allowed. When a critical deviation occurs, a full assessment of its impact on product quality must be carried out, using the established tool for general process risk

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