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
Meet the GMP Compliance Adviser
The GMP Compliance Adviser is the world's largest knowledge portal for quality management in the pharma business.
The demo access is non-binding and ends automatically.
You may also be interested in the following articles:
