Glossary
Pharmaceutical Quality System (PQS)
Also writtenquality management systemQMS
The management system that links organisation, responsibilities, procedures, processes, and resources so that quality objectives are achieved across the product lifecycle.
Source · ICH Q10, Pharmaceutical Quality System, §§1.2–1.8 and Glossary
Related sections
Related terms
Real inspection findings
Findings from regulators' inspection documents in which this term appears.
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The Pharmaceutical Quality System was found inappropriate in order to ensure the corrective and effective application of GMP during the manufacture of the finished products and the complete traceability of materials and production steps.
EMA · EU GMP NCR (EudraGMDP) · 2024-07-03 -
- Pharmaceutical quality system implemented in the company does not allow for adequate identification of risks and the adoption of the necessary measures to avoid them and ensure the quality of the medicinal products manufactured in the facility.
EMA · EU GMP NCR (EudraGMDP) · 2025-02-06 -
Two critical deficiencies concerned the implementation of the pharmaceutical quality system and the knowledge, experience, and number of qualified personnel.
EMA · EU GMP NCR (EudraGMDP) · 2025-12-16
Counted as of 2026-09-24 — the search you land on shows today's figures, so it may differ slightly.
Source
ICH Q10, Pharmaceutical Quality System, §§1.2–1.8 and GlossaryGRM Regulatory Glossary
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