Glossary
Qualification
Demonstrating and documenting that facilities, systems, and equipment are correctly installed, work properly, and give the expected results.
Source · WHO Quality Assurance of Medicines Terminology Database, Qualification; EU GMP Annex 15
Related sections
Related terms
Real inspection findings
Findings from regulators' inspection documents in which this term appears.
-
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 -
• 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stability program • Vendor Qualification and Management Action taken/proposed by the NCA: Others Importers variation withdrawn.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 -
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
Counted as of 2026-09-24 — the search you land on shows today's figures, so it may differ slightly.
Source
WHO Quality Assurance of Medicines Terminology Database, Qualification; EU GMP Annex 15GRM Regulatory Glossary
243 GMP terms in one place
Each term is explained in plain language with its official source. Look it up here whenever you meet a term you don't know.
Browse the whole glossary