The Global Institute for Biomedical Quality (GIBQ) conducts documentary audits. GIBQ does not perform laboratory testing. A certification decision rests on the independent review of laboratory results produced by an accredited independent laboratory, assessed against the published criteria of the GIBQ 7-Point Standard.
This page states what GIBQ examines, how a determination is reached, and the limits of what a GIBQ certificate attests. It is published so that a certificate can be read for exactly what it says.
First
Laboratory standing
Every application names the independent laboratory that produced the submitted results. GIBQ verifies that laboratory's accreditation directly against the public register maintained by the issuing accreditation body — not against the certificate supplied by the applicant. The laboratory must hold current accreditation under ISO/IEC 17025, or an equivalent scheme operated by a nationally recognized accreditation body, covering the test types relied on in the submission.
Accreditation must have been in force on the date the results were issued. A laboratory that cannot be located in the issuing body's public register is not accepted, whatever documentation is submitted alongside it.
The laboratory must also be independent of the applicant: not owned, controlled, or operated by the vendor submitting the documentation for audit.
Second
Document authenticity and traceability
Each submitted Certificate of Analysis is examined for authenticity and for traceability to the specific product lot presented for certification. The lot identifier on the certificate must match the lot presented. A certificate that records testing of a different lot, or that cannot be tied to an identified lot at all, does not support certification of the product presented.
Certificates of Analysis must have been issued within the twelve months preceding the audit. Documentation older than twelve months is not evaluated for conformance; current results are required.
Third
Conformance with the GIBQ 7-Point Standard
The recorded results are assessed against each of the seven points of the GIBQ 7-Point Standard: Identity Verification, Purity, Net Content, Endotoxin, Sterility, Heavy Metals, and Label & Packaging Compliance. Each point carries a published acceptance criterion. Assessment is the comparison of the recorded result to that criterion.
The criteria are published in full, with the analytical method specified for each point, in the standard itself.
Read GIBQ-001 · 7-Point StandardDeterminations are pass or fail against published criteria. Conformance with all seven points is required. A product lot that fails any single point does not qualify for GIBQ Verified certification.
Certification is never issued on any other basis. Not on vendor reputation, market position, volume, commercial relationship, or fee paid. Where the submitted documentation does not meet a published criterion, the criterion governs.
A passing product lot receives a numbered certificate in the format GIBQ-YYYY-NNN, valid for twelve months from the date of issue, subject to no material change in formulation, manufacturing process, or testing laboratory. An applicant whose submission does not pass may submit updated documentation at any time.
Revoked certifications remain listed in the public registry permanently, with the reason for revocation recorded in the registry entry. GIBQ does not delete registry records.
What a GIBQ certificate attests
A GIBQ certificate attests to a documentary finding, and only to that finding. For the product lot identified on the certificate, it attests that:
- the laboratory named in the submitted documentation held current accreditation from a recognized accreditation body when the results were issued, as verified against that body's public register;
- the submitted Certificate of Analysis was traceable to the identified product lot and was issued within the twelve months preceding the audit; and
- the results recorded in that documentation met the published acceptance criterion for each of the seven points of the GIBQ 7-Point Standard.
What a GIBQ certificate does not attest
A GIBQ certificate carries no meaning beyond the documentation reviewed. Specifically:
- GIBQ does not test products. GIBQ performs no laboratory analysis and takes no independent measurement of any product.
- GIBQ does not attest to the safety, efficacy, or fitness of any product for any purpose, including research use.
- A certificate speaks to the product lot identified in the audited documentation. It is not a statement about other lots, other products, or a vendor's operations generally.
- Certification is not an endorsement of a vendor, and it is not a regulatory approval, clearance, or registration of any kind.
- A certificate records that documentation for an identified lot met the standard on the date of audit. It is not a warranty of what a vendor ships.
Related: Independence & Conflict of Interest · Appeals & Complaints · Public registry
Questions on methodology may be sent to info@gibq.org.