# Process performance qualification protocol

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**Process performance qualification protocol** is a component of [process validation](/source/Process_validation): [process qualification](/source/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](/source/Food_and_Drug_Administration) recommends the following criteria be included in a PPQ protocol:[1]

- 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](/source/Quality_control) 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

1. ["Guidance for Industry Process Validation: General Principles and Practices"](https://web.archive.org/web/20140308035346/http://www.fda.gov/downloads/Drugs/Guidances/UCM070336.pdf). Food and Drug Administration. Archived from [the original](http://www.fda.gov/downloads/Drugs/Guidances/UCM070336.pdf) on March 8, 2014. Retrieved 16 December 2014.

## External links

- [casss.org](http://c.ymcdn.com/sites/www.casss.org/resource/resmgr/CMC_No_Am_Jan_Spkr_Slds/2013_CMCJ_LambertWendy.pdf)
- [Process Validation Guidance](https://web.archive.org/web/20110102090006/http://www.fda.gov/OHRMS/DOCKETS/98fr/04d-0001-bkg0001-10-sg3_n99-10_edition2.pdf)

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Adapted from the Wikipedia article [Process performance qualification protocol](https://en.wikipedia.org/wiki/Process_performance_qualification_protocol) by Wikipedia contributors ([contributor history](https://en.wikipedia.org/wiki/Process_performance_qualification_protocol?action=history)). Available under [Creative Commons Attribution-ShareAlike 4.0 International](https://creativecommons.org/licenses/by-sa/4.0/). Changes may have been made.