How to Prepare for an EMA GMP Inspection: A 90-Day Plan
Ninety days out, inspection preparation is not about writing procedures. It is about proving the ones you have were followed: retrieving records against a defined scope, reconciling the story told by your documents with the one told by your staff, and rehearsing the back-room process that retrieves evidence within minutes rather than hours.
Days 90 to 60: establish what the inspector will see
Start from scope, not from anxiety. Identify the products, processes and time period likely to be in scope, then pull the actual records: batch documentation, deviations, CAPAs, change controls, training files, validation reports and the last periodic quality review. Read them as an inspector would, in sequence, following individual threads to their conclusion. The purpose is to find the places where the trail breaks — a deviation closed without effectiveness evidence, a change implemented before approval, a training record for someone who had already left. Writing a new procedure at this stage fixes nothing, because the inspection examines the period already elapsed. What you are doing is discovering your own findings before someone else does.
Days 60 to 30: reconcile documents with practice
The most damaging findings come from the gap between what a procedure says and what people actually do. Walk the process with the operators, not the quality team, and ask them to describe the step in their own words. Where their description differs from the SOP, decide honestly which one is wrong: sometimes the procedure is unrealistic and should be corrected through change control, sometimes practice has drifted and needs correcting. Either way the reconciliation must be documented, because an inspector who finds an undocumented discrepancy will reasonably assume there are others. This is also the window to brief subject-matter experts on answering precisely, without volunteering scope.
Key takeaway
You cannot fix the inspection period in the ninety days before the inspection. What you can do is find your own findings first and be able to explain them.
Days 30 to 0: rehearse the room
Inspections are won and lost on logistics as much as substance. Decide who sits in the front room, who runs the back room, who is authorised to speak on each topic and who says nothing. Rehearse document retrieval against a stopwatch: a request that takes forty minutes to satisfy signals a system nobody can navigate, and invites the inspector to widen scope. Agree in advance how you will handle a question you cannot answer, which is to say so, record it, and come back with the answer rather than improvising. Run at least one full mock inspection in the style of the EU inspectorate, with someone genuinely adversarial in the inspector's chair.
Frequently asked questions
How long does an EU GMP inspection take?
Routine site inspections commonly run two to four days on site depending on scope, product complexity and the number of inspectors, with pre-inspection document requests beforehand and a written report afterwards. Complex or triggered inspections can run considerably longer.
Should we write new SOPs before the inspection?
Only where a genuine gap exists going forward, and always through change control. A procedure dated three weeks before the inspection tells the inspector exactly when you discovered the problem, and it does not retroactively govern the period under review.
What is the single most common finding?
Findings cluster around data integrity and CAPA effectiveness: records that cannot be reconstructed, audit trails not reviewed, and corrective actions closed without evidence that the problem stopped recurring. Both are symptoms of a system operated as documentation rather than as control.
Sources
- EudraLex Volume 4 — Good Manufacturing Practice guidelines, European Commission. health.ec.europa.eu
- Compilation of Union Procedures on Inspections and Exchange of Information, European Medicines Agency. ema.europa.eu
Pending scientific review. This briefing summarises published regulatory guidance and has not yet been signed off by a named subject-matter expert. Verify against the primary sources below before relying on it.
Inspection on the calendar?
We run adversarial mock inspections in the style of the authority you are expecting, and we tell you what we found without softening it.
Explore audits and mock inspections ➔