Glossary
Quality Control (QC)
Setting specifications, sampling, testing, and approving so that materials, intermediates, packaging materials, and finished products conform to the defined specifications.
Related sections
Related terms
Real inspection findings
Findings from regulators' inspection documents in which this term appears.
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Per your response, you initiated CAPA-HOU-025-009 but did not provide an update detailing your assessment of procedures HOU-QC-005, HOU-QC-009, and HOU-QC-014.
FDA · FDA Warning Letter · 2025-11-25 -
Microbiological non sterility and chemical/physical QC control are also carried out at this site.
EMA · EU GMP NCR (EudraGMDP) · 2023-01-17 -
For example, you have not investigated complaints received related to your products, including complaints involving reports of adverse events, in accordance with your written procedures, SOP Q-QC-005, Adverse Events Evaluating and Reporting, Rev.
FDA · FDA Warning Letter · 2022-11-22
