Performance Qualification (PQ; German: Leistungsqualifizierung) is documented evidence that facilities, systems and equipment (German translation: Ausrüstung), when used together as a whole, are operating efficiently and with repeatable performance in accordance with approved requirements and process characteristics.

Performance qualification includes the following elements, among others:

• Realistic tests: Carrying out tests of devices and systems under conditions that are as close as possible to real production scenarios.
• Confirmation of quality standards: Confirmation that the processes meet all specified quality and safety standards and that, for example, limits of microbial monitoring (translation into German: mikrobiologisches Monitoring) are adhered to.
• Evaluation of reproducibility: Testing the ability of devices and systems to reproduce the same results over a longer period of time.
• Data documentation and analysis: Careful documentation of test results and data analysis to confirm consistent production quality and compile a report.

All these steps ensure that pharmaceutical production can reliably and consistently manufacture drugs that meet all the necessary requirements and standards.

Although performance qualification is considered a separate work phase, in some cases it may be useful to carry it out together with operational qualification.

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