Process performance qualification protocol is a component of

process validation Process validation is the analysis of data gathered throughout the design and manufacturing of a product in order to confirm that the process can reliably output products of a determined standard. Regulatory authorities like EMA and FDA have publis ...

process qualification Process qualification is the qualification of manufacturing and production processes to confirm they are able to operate at a certain standard during sustained commercial manufacturing. Data covering critical process parameters must be recorded and ...

. 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 The United States Food and Drug Administration (FDA or US FDA) is a List of United States federal agencies, federal agency of the United States Department of Health and Human Services, Department of Health and Human Services. The FDA is respon ...

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 Deviations from the standard operation procedures should be made within the framework of the protocol and at the approval of relevant

quality control Quality control (QC) is a process by which entities review the quality of all factors involved in production. ISO 9000 defines quality control as "a part of quality management focused on fulfilling quality requirements". This approach places ...

departments. The FDA further recommends a documentation of the protocol be published internally. The report should include: *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

References

External links

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casss.org

Process Validation Guidance
Formal methods Enterprise modelling Business process management Validity (statistics) Drug manufacturing