This standard establishes the minimum requirements for the independent audit and certification of research peptide products by the Global Institute for Biomedical Quality (GIBQ). It applies to vendors seeking the GIBQ Verified certification seal and applies to all peptide compounds intended for research use.

This standard does not apply to pharmaceutical-grade peptide drugs regulated by the FDA or equivalent national authorities, or to in-house research synthesis. Vendors whose products are subject to existing pharmaceutical regulatory frameworks should consult applicable regulatory guidance in addition to this standard.

The following documents are referenced in this standard. Where dated, only the edition cited applies.

• United States Pharmacopeia (USP) General Chapter <232>: Elemental Impurities — Limits
• United States Pharmacopeia (USP) General Chapter <71>: Sterility Tests
• United States Pharmacopeia (USP) General Chapter <85>: Bacterial Endotoxins Test
• ICH Q3D: Guideline for Elemental Impurities
• GIBQ Label Standard, Version 1.0 — gibq.org/standards/label-standard-v1

A document issued by an accredited independent laboratory confirming that a product lot has been tested against specified criteria and meets defined acceptance criteria.

The certification status awarded to a specific product lot upon successful completion of a GIBQ independent audit demonstrating conformance with all seven points of this standard.

A defined quantity of a specific peptide compound produced under uniform conditions, identified by a unique lot number, for which a complete COA has been issued.

For a product lot to receive GIBQ Verified certification, the submitted COA must demonstrate conformance with all seven of the following points. Each point must be supported by results from an accredited independent laboratory.

Point 7 label evaluation is conducted against the GIBQ Label Standard.

Vendors submit the following documentation for each product lot seeking certification: (a) complete COA from an accredited independent laboratory, (b) product label or label image, and (c) laboratory accreditation credentials for the issuing facility.

GIBQ independently reviews submitted documentation against each of the seven points defined in Section 4. GIBQ does not conduct laboratory testing. The audit is a documentary review of results produced by the vendor's designated testing laboratory.

Certification requires conformance with all seven points. A product lot that fails any single point does not qualify for the GIBQ Verified certification. Vendors may re-submit with updated documentation at any time.

Passing product lots receive a numbered GIBQ Certificate of Verification in the format GIBQ-YYYY-NNN. The certificate is valid for twelve months from the date of issue, subject to no material change in formulation, manufacturing process, or testing laboratory.

All GIBQ Verified product lots are listed in the publicly accessible GIBQ Registry. Each listing displays the certificate number, vendor name, compound name, number of certified SKUs, audit date, and current status. The registry is updated upon certification, expiry, or revocation of any certificate.

Certificate status may be set to Active, Expired, or Revoked. A revoked certificate indicates that GIBQ has determined the basis for certification is no longer valid. The reason for revocation is noted in the registry record.

GIBQ maintains strict separation between its certification function and any commercial interest in the peptide supply chain. GIBQ does not manufacture, distribute, or resell peptide compounds. Any person conducting a GIBQ audit must disclose and recuse themselves from any audit in which a conflict of interest exists.

Upon its formation, the GIBQ Scientific & Regulatory Advisory Board will review this standard annually. Board members will serve in a volunteer capacity and will be required to disclose conflicts of interest prior to any standard review or advisory action.

Issued by: Global Institute for Biomedical Quality

Publication Date: April 2026

This standard is subject to annual review by the GIBQ Scientific & Regulatory Advisory Board upon its formation.