Glossary

Pharmaceutical Quality System (PQS)

The management system that links organisation, responsibilities, procedures, processes, and resources so that quality objectives are achieved across the product lifecycle.

Related sections

Related terms

Real inspection findings

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

  1. After the inspection carried out in February 2024, the Company did not put in place an adequate PQS to remove deviations and many of them were also raised during the inspection in June 2024.
    EMA · EU GMP NCR (EudraGMDP) · 2024-07-03
  2. The first critical finding related to the Pharmaceutical Quality System (PQS).
    EMA · EU GMP NCR (EudraGMDP) · 2026-05-05
See 2 findings that mention this term

Source

ICH Q10, Pharmaceutical Quality System, §§1.2–1.8 and Glossary