EMA:Pharmaceutical Quality System (PQS) Effectiveness Pilot Project
EMA launched a pilot under which EEA GMP inspectors will assess how sites demonstrate the effectiveness of their pharmaceutical quality system for risk-based change management, and whether the EEA GMP certificate could serve as the main evidence of this effectiveness.
The pilot will mainly include manufacturing sites producing sterile and / or non-sterile finished products and biological API sites.
The pilot explicitly uses PIC/S guidance PI 054-1 How to Evaluate and Demonstrate the Effectiveness of the Pharmaceutical Quality System with regard to Risk-based Change Management as its assessment basis and will run in selected GMP inspections during 2026-2027.
The GMDP Inspectors Working Group is inviting marketing authorisation holders and manufacturers to nominate their sites for on‑site PQS effectiveness assessments by EEA GMP inspectors.
Source:
EMA: Pharmaceutical quality system (PQS) effectiveness pilot project
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