Glossary
Quality System (FDA Quality Systems Model)
The company-wide quality management system that FDA places at the centre when it divides the CGMP regulations into six systems for inspection.
Details
What it aims at is the same as the pharmaceutical quality system of ICH Q10, but in the United States the term is used more often for the model this guidance sets out and for the systems-based inspection approach built on it. Warning letters repeatedly list violations of individual sections and then gather them under a statement that the firm's quality system is inadequate, with a reference to this guidance, and inspection outcomes are likewise expressed by the quality, facilities and equipment, materials, production, packaging and labelling, and laboratory systems. The judgement therefore rests not on a single finding but on whether the same type of defect appears across several systems at once.
Related sections
Related terms
Real inspection findings
Findings from regulators' inspection documents in which this term appears.
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Quality System Your firm failed to establish an adequate Quality Unit (QU) with the responsibilities and authority to oversee the manufacture of your drug products.
FDA · FDA Warning Letter · 2023-03-14 -
(It should be noted that due to the significant amount of time spent investigating the supply of falsified API to Europe, many elements of the quality system which would normally be covered as part of a routine GMP inspection, were not reviewed on this occasion).
EMA · EU GMP NCR (EudraGMDP) · 2025-12-11 -
See FDA’s guidance document Quality Systems Approach to Pharmaceutical CGMP Regulations for help implementing quality systems and risk management approaches to meet the requirements of CGMP regulations 21 CFR, parts 210 and 211 at https://www.fda.gov/media/71023/download.
FDA · FDA Warning Letter · 2025-03-11
