Glossary

Supplier Qualification

Assessing and approving whether a supplier is able to provide materials or services that consistently meet the defined quality requirements.

Related sections

EU GMP Part I Chapter 1 EU GMP Part I Chapter 7 EU GMP Part I Chapter 8 ICH Q10 §2.7

Related terms

Outsourced Activities2 casesQuality Risk Management (QRM)13 casesStarting Material15 cases

Real inspection findings

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

  1. • Deficiencies in personnel training, supplier qualification and quality control oversight.
    EMA · EU GMP NCR (EudraGMDP) · 2026-07-23
  2. 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
  3. 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
See 18 findings that mention this term

Source

PIC/S PE 009-17, Part I, Chapter 5, Production, §§5.27–5.29 and 5.45
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