GIBQ — Global Institute for Biomedical Quality
  • Documents
  • Standards
  • Registry
  • For Buyers
  • About
  • Newsroom
Apply
GIBQ-001 · Documentation Standard for Research Peptide Suppliers v1.3 · September 2026
Standard Document · GIBQ-001
GIBQ-001: Documentation Standard for Research Peptide Suppliers
The GIBQ 7-Point Standard
Documentation requirements for the independent audit and certification of research peptide suppliers
GIBQ
GIBQ-001
1.3
September 24, 2026
gibq.org/standards/seven-point-standard/v1.3
Version 1.2, which remains available at gibq.org/standards/seven-point-standard/v1.2
Active
GIBQ Operations LLC
1. Scope

1.1 This standard sets out the documentation requirements against which GIBQ Operations LLC (“GIBQ”) audits suppliers of research peptide compounds for certification. It applies to suppliers seeking GIBQ Verified™ certification that sell peptide compounds for laboratory research use only.

1.2 Certification under this standard is a determination about documentation. GIBQ audits the documentation a supplier submits against the seven points in Section 4. GIBQ does not test products, does not collect or analyze samples, does not inspect facilities, and does not verify that any product sold matches the documentation describing it.

1.3 Certification is issued to the supplier, not to a product or a product lot. Each Certificate identifies the products it covers. Certificates of Analysis are reviewed lot by lot, and a product may be covered only as Section 5.3 provides.

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

1.5 This standard is applied through the GIBQ Vendor Verification Agreement and the GIBQ Certification Procedures. Where this standard and either of those documents conflict, the Agreement and then the Procedures control.

2. Normative References

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

The following documents govern how this standard is applied. They are not normative references:

  • GIBQ Vendor Verification Agreement, Version 2.1 — gibq.org/agreement/v2.1
  • GIBQ Certification Procedures, Version 1.1 — gibq.org/procedures/v1.1
3. Definitions
3.1 Certificate of Analysis (COA)

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

3.2 Accredited Independent Laboratory

For purposes of this standard, an accredited independent laboratory is a testing facility that (a) is not owned, controlled, or operated by the supplier submitting documentation for audit; (b) holds current accreditation from a nationally recognized accreditation body; and (c) conducts testing using validated, published analytical methods appropriate to each test type specified herein.

3.3 Product Lot

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.

3.4 Supplier

A business that sells peptide compounds for laboratory research use only and applies for, or holds, a Certificate. A supplier is the “Vendor” under the Vendor Verification Agreement.

3.5 Certificate

The certification record GIBQ issues to a supplier, identified by a unique number in the format GIBQ-YYYY-NNNN.

3.6 Covered Product

A product identified in a Certificate or in the Registry as covered by that Certificate.

3.7 GIBQ Verified

The certification status of a supplier whose Certificate is Active. It follows GIBQ's determination that the documentation the supplier submitted for its Covered Products demonstrated conformance with all seven points of this standard as of the date of the determination.

3.8 Registry

GIBQ's public certification records, including the searchable registry at gibq.org/certified-vendors and the verification pages at gibq.org/verify.

4. The Seven Points

The documentation for each product lot must demonstrate conformance with all seven of the following points. Points 1 through 6 must be supported by results from an accredited independent laboratory, reported on the lot's COA. Point 7 is evaluated by documented review of the product label against the GIBQ Label Standard.

PointTestMethodAcceptance Criterion
1IdentityRP-HPLCConfirmed compound match to reference standard
2PurityHPLC≥ 99.0% by peak area
3Net ContentGravimetric / HPLC≥ 95% of labeled amount
4EndotoxinLAL Test< 1 EU/mg
5SterilityFiltration + IncubationNo microbial growth detected
6Heavy MetalsICP-MSAll elements below USP <232> limits
7Label & Packaging ComplianceDocumented review against GIBQ Label StandardRequired elements present, no prohibited elements

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

5. Audit Process
5.1 Submission

A supplier applies as the Certification Procedures provide, either by submitting a self-prepared application or by supplying documents from which GIBQ compiles an application at the supplier's request. For each product lot submitted, the application includes: (a) a complete COA from an accredited independent laboratory; (b) the product label or a label image; and (c) the laboratory accreditation credentials for the issuing facility. The audit begins only after the supplier's authorized representative attests to, or submits, the application.

5.2 GIBQ Audit

GIBQ independently reviews the submitted documentation, lot by lot, against each of the seven points in Section 4. The audit is a documentary review of results produced by the supplier's designated testing laboratory. GIBQ may confirm with the issuing laboratory that a COA is authentic and unaltered. GIBQ does not conduct laboratory testing.

5.3 Determination

A product is eligible to be a Covered Product only if the documentation for every lot of that product included in the audited application demonstrates conformance with all seven points. A product lot whose documentation does not demonstrate conformance with any single point does not support coverage of that product. If no product qualifies, the application is declined. Suppliers may resubmit with updated documentation, subject to the Certification Procedures.

5.4 Certificate Issuance

A supplier whose application qualifies receives a numbered Certificate in the format GIBQ-YYYY-NNNN. The Certificate identifies the Covered Products and the version of this standard under which it was issued. The initial Certification Term is one year from the date of issue. Renewal requires current COAs for each Covered Product and a new attestation, as the Certification Procedures provide. Material changes, including a change of testing laboratory or manufacturer, must be reported and may lead to review or suspension under the Certification Procedures.

5.5 Limits of Certification

Certification reflects the documentation GIBQ audited as of the date of the determination. It is not a certification, test result, or guarantee concerning the contents of any individual vial, container, lot, or batch. It is not a finding about the identity, purity, potency, quality, sterility, or safety of any product, and it is not approval by the FDA or any other government agency.

6. Public Registry

6.1 Every Certificate GIBQ has issued is listed in the Registry, whatever its current status. Each listing shows the supplier's legal name, trade names, and brand names under which it sells Covered Products; its website domains; the Certificate number; the version of this standard; the Covered Products; the current status; and the dates the Certificate was issued, expires, and changed status.

6.2 A Certificate's status is Active, Suspended, Under Appeal, Revoked, Expired, or Withdrawn, as defined in the Certification Procedures. Only an Active Certificate supports the GIBQ Verified status.

6.3 GIBQ does not publish the grounds for a suspension or revocation, except as the Vendor Verification Agreement permits.

6.4 The Registry is the authoritative record of every Certificate's status and of which products are Covered Products. If any label, display, statement, or document conflicts with the Registry, the Registry controls.

7. Independence and Conflict of Interest

7.1 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.

7.2 Certification decisions are made only by individuals GIBQ designates for that function under the Certification Procedures. Personnel who conduct outreach to suppliers or compile applications do not make, approve, or influence certification decisions. Any person conducting a GIBQ audit must disclose, and recuse themselves from, any audit in which a conflict of interest exists.

7.3 This standard is versioned. Each revision is published as a new, numbered version at its own permanent address, with a summary of changes recorded in Section 8. Once published, a version is never altered, and every prior version remains publicly available for reference.

8. Revision History
VersionDateSummary of Changes
1.0April 2026Initial publication. Seven-point verification standard established. Point 7 references GIBQ Label Standard for detailed label evaluation criteria.
1.1September 2026Removed references to a Scientific & Regulatory Advisory Board, which has not been formed. Section 7 now describes how revisions to this standard are published. No change to the seven verification points or their criteria.
1.2September 2026Certificate number format updated to GIBQ-YYYY-NNNN (four-digit sequence). No change to the seven verification points, their criteria, or any other section.
1.3September 24, 2026Title changed from “Peptide Verification Standard” to “Documentation Standard for Research Peptide Suppliers”; short name “GIBQ 7-Point Standard” retained. Issuer corrected to GIBQ Operations LLC. Sections 1, 3, 5, and 6 conformed to the Vendor Verification Agreement v2.1 and Certification Procedures v1.1: certification is issued to the supplier; each Certificate identifies its Covered Products; Certificates of Analysis are reviewed lot by lot; the Registry lists every Certificate with its current status and does not publish the grounds for a suspension or revocation; and the statuses are those defined in the Procedures. “Certificate of Verification” replaced by “Certificate.” Section 4 introduction clarified that Points 1 through 6 are supported by laboratory results and Point 7 by label review, as the table already specified. Section 7 now describes the separation of certification decisions from outreach. No change to the seven points, their test methods, or their acceptance criteria.

Issued by: GIBQ Operations LLC

Publication date: September 24, 2026

Revisions to this standard are published as new versions. Versions 1.0, 1.1, and 1.2 remain available at gibq.org/standards/seven-point-standard/v1, /v1.1, and /v1.2.

GIBQ™ and GIBQ Verified™ are unregistered trademarks of GIBQ Operations LLC.

GIBQ
70 Middle Neck Road, Suite 5
Great Neck, NY 11021

Standards

7-Point StandardLabel StandardSeal PolicyMethodologyRegistry

About

About GIBQCertification ProcessFor SuppliersIndependenceAppeals & ComplaintsNewsroomDocuments

Contact

General inquiries

info@gibq.org

Press

press@gibq.org

Privacy & legal

privacy@gibq.org

© 2026 GIBQ Operations LLC. All rights reserved.

Global Institute for Biomedical Quality is a name used by GIBQ Operations LLC.

gibq.org is operated by GIBQ Operations LLC, a Delaware limited liability company. GIBQ Operations LLC currently owns all GIBQ intellectual property. GIBQ™ and GIBQ Verified™ are unregistered trademarks of GIBQ Operations LLC. A future two-entity structure with a separate standards-holding nonprofit may be established.

Privacy Policy·Terms of Service·Cookie Policy·Vendor Verification Agreement