Cellular therapy laboratory certification is an independent evaluation of laboratories that manufacture, process, characterize, store, or supply human cellular therapy products. GHA Cellular Therapy Laboratory Certification™ assesses product integrity, donor protection, bidirectional traceability, scientific rationale, and the controls governing how laboratory output reaches clinical use.
FACT
Foundation for the Accreditation of Cellular Therapy
JACIE
Joint Accreditation Committee ISCT-EBMT
AABB
Expand on first use — confirm the current legal name with the organization.
CAP
College of American Pathologists
ISO 15189
Medical laboratories — requirements for quality and competence.
01
Scientific Rationale & Evidence
Documented scientific basis for each product type, and honest classification of the strength of that evidence.
02
Regulatory Classification & Investigational Status
Accurate determination of how each product is classified in every jurisdiction it reaches, and disclosure where status is investigational.
03
Scientific and Ethics Oversight
Independent review structures governing product development and research activity.
04
Donor Eligibility, Protection & Consent
Screening, testing, informed consent, and protections covering every human source of biological material.
05
Cell-Source Declaration & Transparency
Clear declaration of tissue type, donor category, and origin for every product supplied.
06
Bidirectional Traceability
The ability to trace forward from donor to recipient and backward from recipient to donor, across the full product lifecycle.
07
Product Characterization and Relevant Quality Controls
Defined release criteria, identity and potency testing, sterility, and stability appropriate to the product type.
08
Extracellular-Vesicle Characterization, Where Applicable
Characterization methods appropriate to exosome and vesicle preparations, where these fall within the defined scope.
09
Clinical Integration & Patient Protection
Controls governing how laboratory output reaches clinical use, including guidance supplied to treating clinicians.
10
Supply-Chain and Provider Controls
Qualification and monitoring of upstream suppliers and downstream clinical customers.
11
Adverse-Event Reporting & Recall Readiness
Documented processes for receiving safety signals, investigating them, and executing a recall.
12
Marketing & Claims Integrity
Governance ensuring laboratory marketing does not assert clinical efficacy the evidence does not support.
13
Enterprise Governance & Partnership Controls
Contracting, data governance, and multi-client capability required for institutional partnerships.
14
Research Readiness & Trial Integrity
Sponsor and regulatory interfaces, research manufacturing controls, and research integrity systems.
Enterprise Readiness™ and Research Readiness™ are independent layers. A laboratory may hold either, both, or neither, and neither is required to maintain Base Certification.
What products fall within the certification scope?
Three categories: human cellular therapy products; extracellular vesicles derived from human cells, including exosome preparations; and ex vivo genetically modified cellular therapy products. Scope is defined individually for each laboratory, and certification applies only within that defined scope — it is not a general statement about everything the laboratory produces.
Does this certification replace FACT, AABB, CAP, or ISO 15189?
No. It is designed as an overlay. Those frameworks address laboratory and manufacturing quality; GHA adds scrutiny where laboratory operations meet clinical care, scientific claims, patient protection, enterprise partnerships, and research. Qualifying evidence from a recognized framework may satisfy mapped GHA requirements, so certified laboratories are not re-audited on ground already covered.
Is there a certification for exosome laboratories?
Yes. Extracellular vesicles derived from human cells, including exosome preparations, fall within the GHA certification scope where a laboratory includes them in its defined scope. Assessment covers characterization methods appropriate to vesicle products, cell-source declaration, traceability, and the marketing and claims discipline that applies where clinical evidence remains limited.
What is bidirectional traceability?
The ability to trace forward from a donor to every recipient of material derived from them, and backward from any recipient to the originating donor. Both directions matter: forward traceability drives recalls when a donor-related safety signal appears, and backward traceability supports investigation when a patient experiences an adverse event.
What is Research Readiness™?
Research Readiness™ recognizes laboratories with trial-ready capability — research prerequisites in place, working sponsor and regulatory interfaces, research manufacturing controls, product lifecycle management, and research integrity systems. It is an optional layer on Base Certification, intended for laboratories supplying clinical trials or working with research sponsors.
Does certification mean a laboratory's product is approved or clinically proven?
No. Certification evaluates the laboratory's systems, not the therapeutic value of its products. It confers no regulatory approval and makes no claim that any product is effective for any indication. Assessment includes whether the laboratory states regulatory and investigational status accurately in its own communications.
Can a laboratory outside the United States be certified?
Yes. GHA certification is international, and the standards address cross-border supply, differing regulatory classifications between jurisdictions, and the controls required where products move between legal frameworks.
How does laboratory certification relate to GHA's regenerative medicine accreditation?
Certification is for laboratories; accreditation is for the healthcare organizations that treat patients. Together they cover the pathway from cellular source to patient outcome. An organization that both manufactures and treats may hold both, assessed separately.
