Glossary
Equipment Qualification
Documented confirmation, before process validation begins, that critical equipment and ancillary systems are installed and operate as intended.
Source · ICH Q7 (2000), §12.3 Qualification, ¶12.30
Details
More important than what DQ, IQ, OQ, and PQ are each called is the order: this has to be finished before process validation as a prerequisite. The corpus includes qualification performed without a documented programme, cases where the documents submitted did not allow it to be judged whether the qualification was adequate, and inadequate control of the anomalies the qualification revealed. Before asking whether the document package is complete for each item of equipment, check first whether batches made on that equipment were released before qualification was complete.
Related sections
Related terms
Real inspection findings
Findings from regulators' inspection documents in which this term appears.
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records, quality system, personnel training, calibration, labelling management, equipment qualification).
EMA · EU GMP NCR (EudraGMDP) · 2026-08-21 -
In addition, you could not provide evidence that equipment qualification had been performed on your…
FDA · FDA Warning Letter · 2023-01-10 -
For example, in response to our April 16, 2020, communication requesting qualification documentation for the equipment used to manufacture API distributed to the U.S., you indicated that you did not perform equipment qualification and thus could not provide any documents.
FDA · FDA Warning Letter · 2021-04-13
Counted as of 2026-09-24 — the search you land on shows today's figures, so it may differ slightly.
Source
ICH Q7 (2000), §12.3 Qualification, ¶12.30GRM Regulatory Glossary
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