Glossary
Supplier Qualification
Also writtenvendor qualification
Assessing and approving whether a supplier is able to provide materials or services that consistently meet the defined quality requirements.
Source · PIC/S PE 009-17, Part I, Chapter 5, Production, §§5.27–5.29 and 5.45
Related sections
Related terms
Real inspection findings
Findings from regulators' inspection documents in which this term appears.
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• Deficiencies in personnel training, supplier qualification and quality control oversight.
EMA · EU GMP NCR (EudraGMDP) · 2026-07-23 -
Supplier qualification do not include evaluations that provide adequate evidence that the manufacturer can consistently provide material meeting specifications.
FDA · FDA 483 · 2026-07-27 -
The firm is not following their supplier qualification and audit procedures that require a audit of the supplier every two years.
FDA · FDA 483 · 2024-01-17
Counted as of 2026-09-24 — the search you land on shows today's figures, so it may differ slightly.
Source
PIC/S PE 009-17, Part I, Chapter 5, Production, §§5.27–5.29 and 5.45GRM Regulatory Glossary
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