Inside our GMP biobank audits
Quarterly sterile processing reviews, cold chain tracking and Ministry of Health documentation — what we check and why it matters.
Our GMP biobank in Istanbul undergoes a full internal audit every quarter, with an independent external audit conducted annually by a certified third-party laboratory inspector. This article walks through what those audits cover and why each element matters to the families we serve.
Why GMP certification matters
GMP — Good Manufacturing Practice — is the regulatory standard that governs how biological therapies are prepared, stored and released for clinical use. For stem cell preparations, GMP compliance is not optional: it is the difference between a cell product that has been validated for safety and potency, and one that has not.
Every infusion administered to a child or adult in our programme originates from a GMP-certified preparation. That certification is not a one-time achievement. It must be earned and demonstrated continuously.
What our quarterly audit covers
Sterile suite environmental monitoring
We measure airborne particle counts in our ISO Class 5 cleanroom every week. Audit review confirms that no quarterly period has seen a breach of the 3,520 particles per cubic metre threshold at 0.5 µm. Any excursion — even a single reading above limit — triggers immediate investigation and root cause documentation.
Cryogenic storage temperature logs
All cell products are stored in liquid nitrogen vapour phase at −150°C or below. Our monitoring system records temperature every two minutes, 24 hours a day. The audit reviews six months of logs for any excursion and verifies that the alarm response protocol was followed in every instance.
Cell viability and potency testing
Before any product is released for clinical use, a sample is thawed and tested for viability (target: ≥85% live cells) and potency (colony-forming unit assay). Audit review examines every release record for the quarter and flags any batch that required retest.
Consent and traceability documentation
Every cell product is traceable from donor tissue collection through processing, storage and administration. The audit verifies that chain-of-custody documentation is complete and that every family's consent record matches the product batch administered.
Ministry of Health compliance
Turkey's Ministry of Health requires specific documentation for each stem cell preparation and administration. Our compliance team maintains a dedicated audit trail, reviewed quarterly, to ensure no documentation gaps exist.
What families receive
At intake, every family receives a one-page summary of the most recent quarterly audit results. It is written in plain language — not regulatory language — and covers the four metrics families ask about most: sterility record, viability average, temperature excursion count and external audit status.
Transparency is not a marketing position for us. It is the only way to build the trust that this work requires.