Glossary
Quality Unit(s)
The organisational unit, independent of production, that carries out both quality assurance and quality control responsibilities.
Source · ICH Q7, §20 Glossary, Quality Unit(s)
Related sections
Related terms
Real inspection findings
Findings from regulators' inspection documents in which this term appears.
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Your quality unit (QU) did not provide adequate oversight for the manufacture of your over the counter (OTC) drug products.
FDA · FDA Warning Letter · 2023-09-05 -
The records and information you provided did not demonstrate that you have established an adequate quality unit (QU) to oversee the quality of your drug manufacturing operations.
FDA · FDA Warning Letter · 2024-05-14 -
Your quality unit (QU) failed to provide adequate oversight of your CGMP records.
FDA · FDA Warning Letter · 2024-07-23
Counted as of 2026-09-24 — the search you land on shows today's figures, so it may differ slightly.
Source
ICH Q7, §20 Glossary, Quality Unit(s)GRM Regulatory Glossary
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