Performance Qualification (PQ)

Details

Performance qualification is the last stage, confirming that equipment and systems consistently deliver the required performance with real production materials (or a substitute or simulated product shown to behave equivalently), under normal operating conditions and at worst case batch size; unlike OQ, which looks at the equipment operating, it looks at what the equipment produces. EU GMP Annex 15 §3.14 requires the sampling frequency used to confirm process control to be justified, and, absent documented justification from the development phase, requires tests to cover the operating range of the intended process; §3.13 notes that PQ may in some cases be performed together with OQ or process validation. Inspections cite PQ performed only with water or placebo without confirmation using the real product or a justified equivalent, worst case batch size not tested, PQ skipped straight to process validation with no justification, and no justification for the sampling frequency.

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Related terms

Real inspection findings

Findings from regulators' inspection documents in which this term appears.

1. You have not performed process performance qualification (PPQ) studies, nor do you have an adequate ongoing program…

   FDA · FDA Warning Letter · 2026-08-04

2. Specifically, Complaint Record PQC-21-001 was opened October 20, 2021, and was reviewed by our investigators during the inspection.

   FDA · FDA Warning Letter · 2023-05-30

3. In response to Observation 4 of the Form FDA 483, you stated in part: the bag filling line would be decommissioned and a new corporate policy, PQL-QA-0025 will be implemented to ensure equipment is adequate for GMP processes.

   FDA · FDA Warning Letter · 2022-12-20

Counted as of 2026-09-24 — the search you land on shows today's figures, so it may differ slightly.