The GMP / Good Distribution Practice (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.
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.
For more information, see:
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:
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.
For more information on the Product Lifecycle Management document, see:
It is anticipated that the pilot involves PQS effectiveness at a broad range of manufacturing sites:
Chemical API sites, QC-only sites and batch certification-only sites that are related to an application for the use of an PLCM in the EU/EEA may also be proposed to be included in the pilot.
Types of manufacturing sites that can not be included in this pilot include:
In these pilot inspections, the inspectors inspect site change control / change management processes against the requirements of the EU Guide to GMP, using the aforementioned PIC/S PQS paper as supportive guidance as part of the overall routine inspection of the facility.
The inspection in relation to change management cover the following:
An inspection of a volunteering site, where there is no routine inspection planned, will be relatively short in duration, lasting half a day or one day. They would require possibly just one GMP inspector.
Other areas of GMP would not be inspected unless PQS effectiveness in relation to risk-based change management was being checked as part of a routine inspection.
Volunteering companies should familiarise themselves with the content of the PIC/s paper because that paper will be used as supportive guidance by the inspectors during the pilot inspections.
Any observed deficiencies will be recorded versus EU GMP requirements in the normal way.
All pilot inspections will be carried out on a national basis by EEA supervisory authorities, with normal communication between the inspectorate and the site.
Inspection fees will be charged according to the applicable procedures.
Applications to participate in the pilot may be made until 31st December 2026.
Inspections may be carried out up until 1 March 2027.
Marketing authorisation holders or manufacturers that wish to take part in the pilot are requested to complete the application form available on this page and send to EMA at gmpins@ema.europa.eu, using the subject line “PQS Effectiveness Pilot”.
An update log is available to show the date and summary of changes to this webpage. It does not include updates to linked documents or minor edits like typos or broken link fixes.
26 March 2026
Page first published