A GMP certificate confirms that an authority has inspected a manufacturing site and established compliance with Good Manufacturing Practice. For pharmaceutical companies it is the first checkpoint when selecting a contract filler, because without a valid certificate a site may not produce for the EU market. This article explains what the certificate proves, what it does not prove and how to verify it in the EudraGMDP database.
Key takeaways
- The GMP certificate is issued after a regulatory inspection and names the site, the dosage forms and the date of inspection.
- All certificates issued by EU authorities can be viewed in the public EudraGMDP database.
- Lubeca fill is currently preparing EU GMP certification of its plant in Çorlu and communicates the status openly.
What is a GMP certificate?
The certificate is issued by the competent medicines authority after inspectors have visited the site. In Germany these are the state authorities, in Turkey the TİTCK. For sites outside the EU that produce for the EU market, an EU authority carries out its own inspection and issues an EU GMP certificate. The certificate is tied to the site and lists the dosage forms it covers, for example sterile liquids in ampoules or non-sterile liquid dosage forms.
What does the certificate contain?
| Information | Relevance for the client |
|---|---|
| Name and address of the site | Must match exactly the site where your product is manufactured |
| Date of inspection | Certificates are usually renewed after three years by a new inspection |
| Scope | Only the listed dosage forms and activities are covered |
| Issuing authority | Certificates from EU authorities are valid throughout the EU |
| Restrictions | Conditions or excluded areas are stated in the certificate or in a non-compliance statement |
How do you verify a GMP certificate in EudraGMDP?
The European Medicines Agency operates the EudraGMDP database. Manufacturing authorisations, GMP certificates and non-compliance statements of all EU authorities are publicly accessible there. The check takes a few minutes.
- Open the database and select the GMP certificates section
- Search by company name, city or country
- Open the certificate and compare site address, inspection date and scope
- Additionally check the non-compliance section for any objections
If no entry is found, the site has either not yet undergone an EU inspection or has been certified by an authority outside the EU. In both cases you should ask the provider.
What the certificate does not prove
The GMP certificate describes the status on the day of inspection. It says nothing about whether the site has experience with your product, whether spare capacity exists or how the quality system works in everyday practice. This is why chapter 7 of the EU GMP guide requires the client to carry out its own assessment of the contract manufacturer, in practice an on-site audit.
GMP certification at Lubeca fill: the current status
Lubeca fill was founded in 2019 and built its plant in Çorlu near Istanbul with equipment from Groninger, Bausch + Ströbel and Syntegon. EU GMP certification is currently in preparation. This means that the quality system, qualifications and process simulations are being established in accordance with Annex 1, and the regulatory inspection is the next step. We inform interested parties openly about the timeline and make the documents available to auditors. Companies that want to secure capacity early can start qualification in parallel with certification. How an audit works is described in the article on GMP audits. The requirements for sterile sites are summarised in the article on Annex 1.
Frequently asked questions about the GMP certificate
How long is a GMP certificate valid?
The certificate bears the inspection date. Authorities usually re-inspect every three years, more often for higher-risk sites.
Is a Turkish GMP certificate valid in the EU?
No. For the EU market a certificate from an EU authority is required, issued after its own inspection.
May a site without an EU GMP certificate work for clients?
Not for medicinal products placed on the EU market. Different rules apply to development samples, diagnostics or markets outside the EU.
Would you like to know the status of certification at Lubeca fill? Contact us.
