Glossary
Qualification
Demonstrating and documenting that facilities, systems, and equipment are correctly installed, work properly, and give the expected results.
Related sections
Related terms
Real inspection findings
Findings from regulators' inspection documents in which this term appears.
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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stability program • Vendor Qualification and Management Action taken/proposed by the NCA: Others Importers variation withdrawn.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 -
The principal deficiencies across most areas of GMP involved missing or inadequate records of deviation investigations, change management, training, validation and qualification, documentation management, risk assessment, and stability studies.
EMA · EU GMP NCR (EudraGMDP) · 2025-12-16
