Does Your Change Control Drive Decisions, or Just Generate Paper?
The EMA has opened a pilot project assessing pharmaceutical quality system effectiveness at manufacturing sites, with inspections running through March 2027. The specific focus: whether your change control process actually drives decisions or just generates paper.
European GMP inspectors have opened a voluntary pilot built around a question: "when you made that change, what risk did it introduce, and how did you verify the risk was managed?"Â
We run into this on-site all the time. A change control system can be immaculate on paper, fully signed and filed, but it's not always crystal clear what the change actually did to the product, the process, or the patient.
The pilot is run by the GMP/GDP Inspectors Working Group through the EMA. It looks at how a site can show that its quality system genuinely works for risk-based change management, and whether the EEA GMP certificate could stand as the main evidence of that. Inspectors will lean on the PIC/S paper PI 054-1, read alongside the existing EU GMP requirements. If you do one thing with this news, read that paper, whether or not you ever volunteer a site.
The revised variations framework went live in January 2026, and its lighter lifecycle tools, like the Product Lifecycle Management document, only work if you can prove your PQS is effective. This pilot is the inspectorates working out what that proof has to look like.
Manufacturers in the EEA can put their own sites forward. Applications stay open until 31 December 2026, and inspections can run up to 1 March 2027. Volunteer a site with no routine inspection due and you can expect something short: half a day to a day, often just one inspector.
So here is what we would do, application or not. Take your last ten change controls and review them the way you would as if you had volunteered. If the answers take too long or are vague, you have found the gap to work on.