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What is GMP certification? Meaning, EU certificate and written confirmation
GMP certification is the proof that a site making medicines or their ingredients follows good manufacturing practice. For medicines it is not a certificate a company buys. A regulator inspects the site and, if the inspection is passed, issues a GMP certificate. In the EU that certificate comes from a national authority and is published in the EudraGMDP database. In the United States the FDA inspects against current GMP but does not hand out a certificate. Private schemes certify some excipients and supplements, which is where most of the confusion starts.
- 5 related courses
- 46 hours of audio across them
- certificate and training record
- delivered in 72 hours
What does GMP certified mean?
For medicines and active substances, GMP certified means a regulator has inspected the site and accepted it. The inspector checks the quality system, premises, equipment, documentation, production and quality control against the GMP rules of that regulator. The result is an inspection report and, where the regulator issues one, a GMP certificate with a scope: which products, which operations, which date.
How do you get GMP certification in the EU?
A manufacturer inside the EU needs a manufacturing authorisation from its national authority, and the authority inspects the site regularly. A site outside the EU that supplies the EU market is inspected by an EU authority, or by a partner authority under a mutual recognition agreement. Each GMP certificate and each statement of non-compliance is entered in EudraGMDP, so a European customer can check your status before the first order.
GMP certificate versus written confirmation
Since 2013, Article 46b of Directive 2001/83/EC has required every active substance imported into the EU to arrive with a written confirmation. It is signed by the regulator of the exporting country and states that the site follows GMP at least equivalent to EU GMP and is inspected. It is not an EU GMP certificate, and an EU certificate does not replace it. A short list of countries whose systems the EU has assessed as equivalent are exempt.
What is cGMP certification in the United States?
The United States rules for finished medicines are in 21 CFR 210 and 21 CFR 211. The FDA enforces them by inspection, and the outcome is the inspection record, not a certificate. Export customers in Europe will still ask for your EU status, because FDA compliance alone does not satisfy EU GMP.
GMP certification for supplements and excipients
Dietary supplements in the United States follow their own GMP rule, 21 CFR 111. Seals saying a supplement plant is GMP certified come from private programmes, not from the FDA. Excipients sit in a similar space: EXCiPACT is a private certification scheme for excipient GMP, and EU marketing authorisation holders must also run a formal risk assessment on each excipient supplier. The courses below cover the regulator’s route and the private schemes, 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.
- European Union: Article 46b, written confirmations and GMP certificates for third-country API8 modules · 8 hours of audio · RA, QA, BD · 72 EUR per learner per year
- From Indian GMP to EU GMP: the gap list, and how to close it10 modules · 10 hours of audio · India companies · 90 EUR per learner per year
- United States: 21 CFR 210 and 211 versus EU GMP, the differences that catch exporters8 modules · 8 hours of audio · RA, QA, BD · 72 EUR per learner per year
- GMP for excipients: IPEC, EXCiPACT and what a pharma customer expects of your plant8 modules · 8 hours of audio · Excipient suppliers · 72 EUR per learner per year
- Europe playbook for the nutraceutical company: licences, documents, customers, cost12 modules · 12 hours of audio · Nutraceutical and natural products · 108 EUR per learner per year
Questions about GMP certification
What does GMP certified mean?
For a medicine or active substance site it means a regulator has inspected the site and found it compliant with good manufacturing practice. The proof is the inspection report and, in the EU, a GMP certificate that anyone can look up in EudraGMDP.
Can I buy GMP certification from a consultant?
Not for medicines. A consultant can prepare you for inspection, and a private body can audit you, but only a regulator can issue a GMP certificate for a medicine or active substance site. Be careful with any offer that says otherwise.
What is the difference between a GMP certificate and a written confirmation?
A GMP certificate is issued by the authority that inspected the site. A written confirmation is issued by the regulator of the exporting country and travels with an active substance into the EU, confirming that local GMP is at least equivalent to EU GMP.
Is cGMP certification different from GMP certification?
cGMP means current good manufacturing practice, the United States term in 21 CFR 210 and 211. The FDA checks it by inspection and does not issue a cGMP certificate. A company claiming cGMP certification usually means it passed an FDA inspection.
How long does GMP certification take?
It depends on the regulator's inspection schedule and on how ready the site is. Most of the time goes into closing the gaps before the inspection, not the inspection itself, which usually lasts a few days.
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 auditor. It is not a GMP certificate, a professional qualification or an accreditation.
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