Glossary

Qualification

Demonstrating and documenting that facilities, systems, and equipment are correctly installed, work properly, and give the expected results.

Related sections

EU GMP Annex 15 §§1–4 EU GMP Annex 11 §4

Related terms

Design Qualification (DQ)Installation Qualification (IQ)1 casesOperational Qualification (OQ)3 cases

Real inspection findings

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

  1. We acknowledge you have consulted with a third-party firm to provide temperature mapping and qualification of equipment at your facility to include your (b)(4) .
    FDA · FDA Warning Letter · 2025-11-25
  2. • Cleaning Validation • Process Validation • Physical/Chemistry Laboratory • Investigation of OOS Results • Management of the stability program • Vendor Qualification and Management Action taken/proposed by the NCA: Others Importers variation withdrawn.
    EMA · EU GMP NCR (EudraGMDP) · 2024-08-02
  3. Regarding your media fills, we acknowledge your commitments to expand your media fill batch sizes and strengthen your personnel qualification as well as revise your existing procedures.
    FDA · FDA Warning Letter · 2025-04-29
See 805 findings that mention this term

Source

WHO Quality Assurance of Medicines Terminology Database, Qualification; EU GMP Annex 15
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