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GMP inspection checklist: what EU and FDA inspectors check
A GMP inspection checklist is a list of the areas an inspector will examine and the evidence you must be able to show for each. In the EU the structure comes from the GMP guide in EudraLex Volume 4: quality system, personnel, premises and equipment, documentation, production, quality control, outsourcing, complaints and recalls, and self inspection. The FDA groups the same ground into six systems. A useful checklist is built on that structure and filled with your own products, risks and past findings.
- 5 related courses
- 44 hours of audio across them
- certificate and training record
- delivered in 72 hours
What is on an EU GMP inspection checklist?
The nine chapters of Part I of the EU GMP guide give the skeleton. Under each chapter, list what an inspector will ask to see. For the quality system, that means the management review and its trend data. For personnel, job descriptions and training records. For premises and equipment, qualification status, maintenance and cleaning. For documentation, how records are controlled and how data integrity is assured. Then add the annexes that apply to you: sterile manufacturing, computerised systems, qualification and validation.
How does an EMA inspection work?
The EMA coordinates inspections for products authorised through the centralised procedure, but the inspectors come from the national authorities. A typical inspection opens with a presentation of the site, then moves through a tour, document review and interviews, and closes with a meeting where the main findings are read out. The written report follows, and the site has a fixed time to send its corrective action plan.
What does the FDA check?
FDA investigators work through six systems: quality, facilities and equipment, materials, production, packaging and labelling, and laboratory controls. Quality is always covered. The laboratory and data integrity get close attention at foreign sites, especially audit trails, test injections and repeat testing. The investigator writes observations on Form 483 at the close-out meeting.
How should a site prepare?
Run the checklist as a self inspection months before the date, not days. Close or justify open deviations and CAPAs, check that training records match the people doing the work, and rehearse the logistics: who meets the inspector, who runs the back room, how documents are fetched and logged. The courses below cover EU and FDA inspections and the checklists European customers use, by role, with a recorded questionnaire at the end of each module.
This guide belongs to GMP, GDP, quality and compliance: 24 audio courses for your team, 24 courses.
Courses that teach this, priced per learner per year
Each course is audio modules in three lengths, with workbook, transcript, a recorded questionnaire per module, a certificate and the training record. Prices are the list price per learner for a year; the price falls with more learners.
- Day one, the inspectors arrive: how an EMA or national GMP inspection really runs10 modules · 10 hours of audio · QA, production, management · 90 EUR per learner per year
- United States: Form 483, warning letter, import alert, how the FDA inspects a foreign site10 modules · 10 hours of audio · RA, QA, BD · 90 EUR per learner per year
- Hosting an EU or FDA inspection, on site and remote: roles, the back room, the answers8 modules · 8 hours of audio · QA, management · 72 EUR per learner per year
- What the European auditor opens first at the finished-dose generic company: the checklist8 modules · 8 hours of audio · Finished-dose generic company · 72 EUR per learner per year
- What the European auditor opens first at the API and intermediates maker: the checklist8 modules · 8 hours of audio · API and intermediates maker · 72 EUR per learner per year
Questions about GMP inspection checklist
What does an EU GMP inspector check first?
Usually the quality system: management review, deviations, CAPA, change control and the trend data behind them. From there the inspector follows threads into production, the laboratory and the warehouse. Weak records in the quality system are the fastest way to a long list of findings.
What documents should be ready for a GMP inspection?
The site master file, organisation charts, the list of procedures, batch records for the products in scope, the deviation and CAPA logs, change controls, validation status, training records, complaints, recalls, the self inspection programme and the supplier qualification files.
How are EU inspection findings graded?
As critical, major or other deficiencies. A critical deficiency can mean a risk to patients and may lead to a statement of non-compliance. The site answers each finding with a corrective action plan, and the outcome is recorded in EudraGMDP.
What is an FDA Form 483?
It is the list of observations an FDA investigator hands over at the end of an inspection. The company should answer in writing within fifteen business days. Observations that are not resolved can lead to a warning letter and, for foreign sites, an import alert.
Is a GMP audit checklist the same as an inspection checklist?
They overlap. A customer audit checks GMP too, but it also checks what that customer cares about commercially, such as supply security, change notification and quality agreements. Use the inspection checklist as the base and add the customer's own questionnaire on top.
Is the course certificate a GMP certification?
No. The certificate records that a named person completed the course and its questionnaires, with hours, guideline version and date. It is evidence of training for your inspector or customer. It is not a GMP certificate, a professional qualification or an accreditation.
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