1What a GMP certificate is.
EMA defines a GMP certificate as one “issued following a GMP inspection, by the competent authority responsible for carrying out the inspection, to confirm the GMP compliance status of the inspected site”. Certificates are site-specific, and can be limited to particular activities depending on the scope of the inspection, such as manufacture of one product.¹
The obligation is in EU law. Article 111(5) of Directive 2001/83/EC requires a certificate of GMP to be issued to the inspected entity, where applicable, within 90 days of an inspection whose outcome shows it complies. Member States enter the certificates they issue in a Union database managed by EMA, which is publicly accessible (Article 111(6)), and record there any finding that an inspected entity does not comply (Article 111(7)). Member States and EMA together set the certificate’s form and content (Article 111a).² That database is EudraGMDP, which also holds manufacturing and import authorisations and the registrations of active substance manufacturers.³
A certificate is not a licence. Manufacturers and importers in the EEA must hold an authorisation from the national competent authority, and must comply with EU GMP to obtain it.³ The certificate records what an inspection found.
2Who issues one.
EMA does not issue GMP certificates: the authority that carried out the inspection issues the certificate, or enters a statement of non-compliance in EudraGMDP.¹ In the EU, national competent authorities inspect the sites on their territory, and sites outside the EU are inspected by the authority of the Member State where the importer is located, unless a mutual recognition agreement applies.³ Every EU and EEA authority that inspects must enter its certificates in EudraGMDP, so “any GMP certificate appearing in the database is mutually recognised and the database authenticates the certificate”.¹
In the UK, the MHRA sends a post-inspection letter listing any deficiencies. Once it accepts the company’s response on corrective actions and dates, it issues a GMP or GDP certificate with the inspection report.⁴
FDA reports a US site’s status differently. Its electronic certificates of pharmaceutical product, issued only for drugs exported from the US, give the drug’s US marketing status and “the manufacturer’s compliance with FDA’s requirements”, in the WHO format, and expire after 24 months.⁵ Where a foreign regulator won’t accept a valid certificate of pharmaceutical product, FDA can send it a CGMP declaration for a US site whose latest FDA inspection was acceptable, within 30 days of the request. Foreign regulators can also check a site’s most recent inspection classification on FDA’s Data Dashboards.⁶
3Certificates that are easy to confuse.
| Document | What it confirms | Who issues it |
|---|---|---|
| GMP certificate | A site’s GMP compliance for the activities inspected | The authority that inspected the site¹ |
| Non-compliance statement | That an inspected site did not comply | The inspecting EU authority, in EudraGMDP¹ |
| Certificate of a pharmaceutical product (CPP), called a CMP in the EU | A product’s marketing authorisation status and the GMP status of its sites, under the WHO certification scheme | The authority that granted the marketing authorisation, or EMA on the Commission’s behalf for centrally authorised products¹; FDA for drugs exported from the US⁵ |
| Certificate of suitability (CEP) | That an active substance meets the relevant European Pharmacopoeia monograph | EDQM¹ |
| CGMP declaration | The CGMP status of a US site FDA has inspected | FDA, sent directly to a foreign regulator⁶ |
| ISO 13485 certificate | That a device maker’s quality system conforms to the standard | Issued after third-party audits. FDA neither requires nor issues them, and one does not exempt a site from FDA inspection⁷ |
The WHO certification scheme rests on WHO’s GMP text, which WHO says “shall be used as a standard to justify GMP status” within the scheme.⁸ Some authorities outside PIC/S accept GMP certificates issued by PIC/S Participating Authorities.⁹
4How certificates are used and lost.
For EU submissions no paper copy is needed: a reference to EudraGMDP is enough, and EU authorities “strongly encourage reliance on the database”. Concerns about an entry go to the issuing authority.¹ A certificate is also useful evidence when qualifying a supplier, but it does not replace the manufacturer’s own duties. EMA says inspection reports and GMP certificates for an active substance supplier “alone cannot fulfil the statutory obligations” of the manufacturing authorisation holder, though they can help set priorities in a risk-based audit programme.¹
During COVID-19, EU inspectors extended the validity of GMP certificates; that extension ended with 2024, and national authorities now decide any further extension case by case.³ A non-compliance statement can in principle only be lifted by a new inspection that results in a certificate. For a third-country site that has dropped out of marketing authorisations, the issuing authority adds a clarifying remark when the statement has stood for a long time.¹
5How it runs in Seal.
In Seal, inspection readiness logs each request with its verbatim wording, agreed interpretation, owner and the evidence delivered. Evidence is retrieved from connected records with their history, a delivered package keeps its source record versions, and observations become commitments linked to CAPA and verification. Training and calibration status can be shown for the date of the work, not only today.
Each record keeps its audit history and electronic signatures, with controls to support 21 CFR Part 11 and EU GMP Annex 11, as Regulatory and validation sets out. No software alone makes an operation compliant: your quality system, configuration, procedures and training remain part of the assessment.
References
- 1Guidance on good manufacturing practice and good distribution practice: questions and answers, GMP certificates, non-compliance statements and manufacturing authorisations, European Medicines Agency. https:/
/ www. ema. europa. eu/ en/ human- regulatory- overview/ research- development/ compliance- research- development/ good- manufacturing- practice/ guidance- good- manufacturing- practice- good- distribution- practice- questions- answers (read 6 November 2026) - 2Directive 2001/83/EC on the Community code relating to medicinal products for human use, Articles 111 and 111a, EUR-Lex, consolidated text of 1 January 2025. https:/
/ eur- lex. europa. eu/ legal- content/ EN/ TXT/ ?uri=CELEX:02001L0083- 20250101 (read 6 November 2026) - 3Good manufacturing practice, European Medicines Agency. https:/
/ www. ema. europa. eu/ en/ human- regulatory- overview/ research- development/ compliance- research- development/ good- manufacturing- practice (read 6 November 2026) - 4Medicines: good manufacturing practice and good distribution practice, MHRA. https:/
/ www. gov. uk/ guidance/ good- manufacturing- practice- and- good- distribution- practice (read 6 November 2026) - 5Electronic Certificates of Pharmaceutical Product, FDA. https:/
/ www. fda. gov/ drugs/ human- drug- exports/ electronic- certificates- pharmaceutical- product (read 6 November 2026) - 6Current Good Manufacturing Practice Declarations, FDA. https:/
/ www. fda. gov/ drugs/ human- drug- exports/ current- good- manufacturing- practice- declarations (read 6 November 2026) - 7Quality Management System Regulation: Frequently Asked Questions, question 13, FDA. https:/
/ www. fda. gov/ medical- devices/ quality- management- system- regulation- qmsr/ quality- management- system- regulation- frequently- asked- questions (read 6 November 2026) - 8WHO good manufacturing practices for pharmaceutical products: main principles, TRS 986 Annex 2, World Health Organization, 2014. https:/
/ www. who. int/ publications/ m/ item/ trs986- annex2 (read 6 November 2026) - 9Benefits, PIC/S. https:/
/ picscheme. org/ en/ benefits (read 6 November 2026)
AQuestions and answers
Can a person get a GMP certificate?
Not a regulatory one. Under EU law a GMP certificate goes to the inspected entity, a manufacturing site, after an inspection; distributors receive GDP certificates. A training provider’s certificate shows that someone completed a course; it isn’t a GMP certificate in the regulatory sense.
How do I check whether a site has an EU GMP certificate?
Search EudraGMDP, EMA’s public database. Every EU and EEA inspectorate must enter its GMP certificates and non-compliance statements there, and the database authenticates the entries. If a certificate can’t be found, contact the authority that is said to have issued it.
Does FDA issue GMP certificates?
Not under that name. For drugs, FDA conveys a site’s compliance in other ways: certificates of pharmaceutical product in the WHO format for drugs exported from the US, CGMP declarations sent directly to foreign regulators, and inspection classifications on its data dashboard. For medical devices, FDA neither requires nor issues ISO 13485 certificates.
Is a supplier’s GMP certificate enough to qualify it?
No. EMA says certificates and inspection reports for an active substance supplier are useful information but cannot by themselves meet the manufacturer’s legal obligations. They can be used, with other information, to set priorities in a risk-based supplier audit programme.
How long is a GMP certificate valid?
Ask the authority that issued it. EU inspectors extended certificate validity during COVID-19 until the end of 2024; that extension no longer applies, and national authorities decide case by case whether any certificate needs a further extension.
What is the difference between a GMP certificate and a manufacturing authorisation?
The authorisation is the licence to manufacture or import, granted by the national competent authority, and a company must comply with GMP to obtain it. The certificate records that an inspection found a site compliant for the activities inspected.