Process performance qualification protocol

Process performance qualification protocol is a component of process validation: process qualification. This step is vital in maintaining ongoing production quality by recording and having available for review essential conditions, controls, testing, and expected manufacturing outcome of a production process. The Food and Drug Administration recommends the following criteria be included in a PPQ protocol:Manufacturing conditions: Operating parameters, equipment limits, and component inputs What data should be recorded and analyzed What tests should be performed to ensure quality at each production step A sampling plan to outline sampling methods both during and between production batches Analysis methodology that allows for data scientific and risk oriented decision making based on statistical data. Variability limits should be defined and contingencies in the event of non-conforming data established Approval of PPQ protocol from relevant departments

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