Regulatory
How to verify that a laboratory is licensed to process human cells
GMP describes how a facility works. A licence describes what it is legally permitted to do with human tissue — and the two are not interchangeable.
- Medically reviewed by:
- Prof. Dr. Erdal Karaöz Team
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- Next review:
The short answer
Ask which authority licenses the facility to procure, process and store human cells, and ask for the licence number. In Türkiye this sits with the Ministry of Health, with medicines-side oversight from TİTCK; in the EU it is the national competent authority under the Tissues and Cells framework; in the US, establishments handling HCT/Ps register with the FDA under 21 CFR Part 1271. A facility that cannot name its licensing authority is not one you can verify at all.
How to verify it, step by step
These steps work at any clinic, anywhere. Nothing here depends on choosing us.
- Ask the direct question: 'Which authority licenses this facility to process human cells, and what is the licence number?'
- Ask separately about the tissue source. Donation, consent and screening of umbilical cord tissue are licensed activities in their own right.
- Ask whether the product is classified as a tissue preparation or as an advanced therapy medicinal product in that country, because the obligations differ sharply.
- Ask where the cells are stored, under whose licence, and for how long the donor records are retained.
- Check the register if the country publishes one, and ask for the inspection date if it does not.
- Ask what happens to a batch that fails release testing, and who is notified. A licensed facility has a written deviation procedure; an unlicensed one improvises.
What good looks like, and what should worry you
| What you are checking | An acceptable answer | A red flag |
|---|---|---|
| Licensing authority | A named national body with a licence number | 'We work with a licensed partner', no name |
| Donor screening | Serology and history screening described, records retained | No answer, or 'the donor is healthy' |
| Product classification | Stated clearly, with the applicable framework | Deliberate vagueness about legal status |
| Traceability | Donor-to-patient traceability with retained records | No batch or donor identifiers on paperwork |
| Deviation handling | A written procedure for failed batches | Nobody has ever failed a batch |
| Storage | Named licensed storage site and conditions | Cells 'kept ready' with no stated conditions |
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 tissue-establishment or processing licence, with number and validity dates
- The donor screening and consent policy summary
- The product's regulatory classification in the country of treatment
- The traceability policy: how a vial is linked back to a donor and forward to you
- The written procedure for a batch that fails release criteria
Do not write it yourself: copy our ready-made email and WhatsApp request.
Frequently asked questions
Related verification guides
- How to verify GMP certification
- How to read a Certificate of Analysis
- Our credentials and quality standards
- 25 questions to ask before travelling
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.