Glossary

Quality Assurance (QA)

The total arrangement of everything that bears on ensuring a medicine has the quality required for its intended use.

Related sections

ICH Q10 §§1.5–1.8 21 CFR 211.22

Related terms

Good Manufacturing Practice (GMP)767 casesQuality Control (QC)4 casesPharmaceutical Quality System (PQS)2 cases

Real inspection findings

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

  1. Your Quality Assurance (QA) and production departments failed to provide adequate oversight and ensure the reliability of data related to the quality of finished drug products manufactured at your facility.
    FDA · FDA Warning Letter · 2023-11-28
  2. The final reports for studies (b)(4) did not include the correct names of the study director and other scientists or professionals involved in the study, such as the quality assurance unit (QAU) personnel.
    FDA · FDA Warning Letter · 2026-03-17
  3. The company had been subjected to 3 previous inspections, these inspections had defined similar issues as were observed during current inspection indicating a lack of QA oversight and inadequate approach with regard to addressing the issues identified during GMP inspection.
    EMA · EU GMP NCR (EudraGMDP) · 2019-11-25
See 5 findings that mention this term

Source

WHO Quality Assurance of Medicines Terminology Database, Quality assurance
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