Find out where an inspector would find you
Nine chapters of EU GMP Part I, eight hard questions each. Take one chapter in six minutes or the whole thing in a sitting. Free, no sign-up, results stay in your browser.
Scenario questions, not definitions
Every question is a situation from a real site. Four options, one that would hold up in front of an inspector.
A clause reference on every answer
Right or wrong, you get the explanation and the exact chapter and paragraph so you can check it yourself.
A recommendation, not a sales pitch
Chapters below 75% map to specific courses. Two or more gaps and we bundle them at 20% off. No course yet? We offer a call instead.
EU GMP Part I, chapter by chapter
Pharmaceutical Quality System
Management responsibility, quality risk management, deviations, CAPA, change control and product quality review.
8 questionsPersonnel
Key personnel, training, hygiene and the responsibilities of the Qualified Person and heads of QC and production.
8 questionsPremises and Equipment
Facility design, cross-contamination control, calibration, maintenance and the validated state of equipment.
8 questionsDocumentation
Good documentation practice, records, batch documentation, data integrity and retention.
8 questionsProduction
Starting materials, in-process controls, line clearance, prevention of mix-ups and validation of processes.
8 questionsQuality Control
Sampling, testing, OOS investigations, stability programmes and laboratory data.
8 questionsOutsourced Activities
Contract givers, contract acceptors, quality agreements and oversight of suppliers and contract labs.
8 questionsComplaints, Quality Defects and Recalls
Handling complaints, investigating defects, deciding on and executing recalls, and notifying authorities.
8 questionsSelf-Inspection
Internal audit programmes, independence, follow-up and how self-inspection feeds the quality system.
8 questionsThe full assessment
All nine chapters, 72 questions, about 45 minutes. Pause any time; progress is saved. Get a readiness score, a chapter heatmap and a bundled recommendation.