Manufacturing quality
How to verify a GMP certificate for a stem cell laboratory
A GMP logo on a website proves nothing. A GMP certificate names an issuing authority, a site address, a scope and an expiry date — and those four fields are checkable.
- Medically reviewed by:
- Prof. Dr. Erdal Karaöz Team
- Last reviewed:
- Next review:
The short answer
Ask for a scan of the actual certificate, then check four things: who issued it, which physical site it covers, what activities are inside its scope, and when it expires. A certificate covering 'cosmetic production' or a different address than the lab processing your cells does not cover your treatment. In Türkiye, manufacturing authorisations and GMP inspections sit with the Ministry of Health and TİTCK, so the issuer should be a named regulator, not a private consultancy.
How to verify it, step by step
These steps work at any clinic, anywhere. Nothing here depends on choosing us.
- Request the certificate as a PDF or scan, not a photograph of a wall plaque and not a logo in a brochure.
- Read the issuing body. A national medicines agency or health ministry is meaningful; a private 'certification institute' with no regulatory standing is not.
- Match the site address on the certificate to the laboratory that will actually process your cells. Outsourced processing is common and legitimate, but the certificate must belong to whoever does the work.
- Read the scope line. GMP is granted for defined activities and product classes. Ask explicitly whether cell-based products for human administration are inside that scope.
- Check the issue and expiry dates, and ask when the last inspection took place. Certificates lapse.
- Cross-check against the regulator where a public register exists — EudraGMDP for EU/EEA sites, the national agency elsewhere.
- Ask, in the same email, who the Qualified or Responsible Person is for batch release. GMP without a named release authority is a paper exercise.
What good looks like, and what should worry you
| What you are checking | An acceptable answer | A red flag |
|---|---|---|
| Issuer | A national regulator or health ministry named on the certificate | A private company, a trade body, or no issuer stated |
| Site | The address matches the lab that processes your cells | A head-office or hospital address with no lab named |
| Scope | Explicitly covers cell-based products for human use | Covers cosmetics, supplements or 'research use only' |
| Validity | In-date, with a stated last inspection | Expired, undated, or 'renewal in progress' with no evidence |
| Release | A named Qualified/Responsible Person signs batch release | Nobody can tell you who releases the batch |
| Willingness | Sent by email within a day or two | Shown only on-site, after payment, or 'confidential' |
How we grade claims like these: How we evaluate evidence · Editorial standards · Conflict-of-interest disclosure.
Documents to request in writing
Ask by email so the answer is documented. A clinic that cannot send these before payment is telling you something.
- The GMP or manufacturing authorisation certificate for the processing site (PDF)
- The date of the most recent regulatory inspection and its outcome
- The name and role of the person responsible for batch release
- Written confirmation that your product class is inside the certified scope
- If processing is outsourced, the contract laboratory's own certificate
Do not write it yourself: copy our ready-made email and WhatsApp request.
Frequently asked questions
Related verification guides
- How to verify a cell-processing licence
- How to read a Certificate of Analysis
- What GMP cell manufacturing involves
- Laboratory transparency report
Use this on us too
Send these questions to us exactly as written. We answer them with documents, and if something does not apply to your case we say so.