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EEA PQS effectiveness pilot project

Date
March 26, 2026
Category

EU Regulations

Description

The GMP/GDP Inspectors Working Group is running a pilot to assess how the effectiveness of a site’s pharmaceutical quality system (PQS) for risk‑based change management can be demonstrated, and whether the EEA GMP certificate could serve as the main evidence of this effectiveness. See Pharmaceutical quality system (PQS) effectiveness pilot project | European Medicines Agency (EMA)

Demonstrating robust PQS effectiveness is a key requirement for using the additional regulatory tools introduced under the revised variations framework, which became applicable in the EU in January 2026. This includes tools such as the product lifecycle management (PLM) document.

As the basis for their assessment, EU authorities have adopted the guidance developed by the Pharmaceutical Inspection Co-operation Scheme (PIC/S) 'How to Evaluate and Demonstrate the Effectiveness of the Pharmaceutical Quality System with regard to Risk-based Change Management' (PIC/S PI 054-1).

EEA GMP inspectors will pilot the use of this guidance in selected GMP inspections between 2026 and 2027. The working group is inviting marketing authorisation holders and manufacturers to nominate their sites for on‑site PQS effectiveness assessments by EEA GMP inspectors.

There are two ways in which a site could be volunteered to be included in the pilot:

  • Manufacturers can nominate themselves to participate in the pilot until December 2026 if they are located in the EEA. It is not necessary to submit an ICH Q12 variation in order to participate in this pilot.
  • Marketing Authorisation Holders can nominate sites located in the EEA for inclusion in the pilot if there is a planned variation submission concerning a Product Lifecycle Management document until December 2026 that will rely on the PQS of the manufacturer.

EEA supervisory authorities will also nominate some sites located in the EEA for inclusion in the pilot based on their planned inspections until December 2026.

It may be possible that a site located outside the EEA, could be included in the pilot if the site is scheduled for an inspection by an EEA authority. Sites that are located in a territory of an MRA partner will not be included in the pilot. Inspection fees will be charged in the normal way.