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: Deviations from the standard operation procedures should be made within the framework of the protocol and at the approval of relevant quality control departments. The FDA further recommends a documentation of the protocol be published internally. The report should include:
 * 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
 * A summation of relevant data and analysis from the protocol
 * An explanation of unexpected data and any other results not mandated by the protocol and its effects on production quality
 * Identify correlating effects and suggest changes to existing processes
 * Conclude if the process performance is adequately qualified to meet performance standards. Should production standards not be met appropriate changes should be outlined