Quality Assurance Plan

1. Purpose

This Quality Assurance (QA) Plan defines the policies, responsibilities, and controls Caliber Labs uses to ensure that research reference standards are sourced, handled, tested, documented, and distributed in a manner appropriate for qualified laboratory and in-vitro research use.

All products supplied by Caliber Labs are designated Research Use Only (RUO). They are not medicines, drug products, dietary supplements, or consumer health products.

2. Scope

This plan applies to:

• Peptide and related research reference materials offered through caliberlabs.co
• Incoming receipt, storage, fulfillment, and shipment from Florida, USA
• Third-party analytical testing and Certificate of Analysis (COA) documentation
• Customer communication regarding lot identity, purity, and quality records

3. Quality policy

Caliber Labs is committed to supplying analytical-grade reference materials supported by documented quality controls, independent laboratory verification where applicable, and lot-specific COA records.

Our quality objectives include:

• Maintaining identity and purity standards of ≥99% where specified for applicable lots
• Issuing lot-specific documentation with every certified batch
• Using accredited third-party laboratories for independent analytical testing
• Tracing each distributed lot from supplier receipt through customer shipment
• Investigating and correcting quality deviations through documented CAPA

4. Organization and responsibilities

Quality oversight is the responsibility of Caliber Labs management. Day-to-day QA activities may be performed by designated operations, fulfillment, and compliance personnel.

• Quality Responsible Person: approves QA procedures, reviews non-conformances, and authorizes recalls when required
• Operations: receiving, inventory control, packaging, and shipment verification
• Documentation: COA publication, lot record retention, and customer quality inquiries

Quality inquiries may be directed to support@caliberlabs.co or through the Contact page.

5. Supplier qualification

Materials are sourced from suppliers operating under documented quality-management standards and controlled production procedures, including cGMP-aligned facilities where applicable.

Supplier evaluation considers:

• Documented manufacturing and quality procedures
• Batch traceability and lot numbering practices
• History of analytical conformance and supply reliability
• Ability to support investigation of quality deviations

6. Receiving and incoming controls

Upon receipt, inbound materials are reviewed for:

• Correct product identity and catalog match
• Intact primary and secondary packaging
• Legible lot or batch identification
• Appropriate cold-chain or storage condition indicators where required

Materials that fail incoming inspection are quarantined, documented, and not released for distribution until disposition is determined.

7. In-process and finished-product controls

Products undergo controlled processing, filtration, and quality-assurance review as part of internal protocols prior to release.

Finished lots are supported by:

• HPLC and/or mass spectrometry identity and purity verification by independent laboratories
• Lot-specific COA records published through AuthentiChain where certified
• Internal review of analytical results against release criteria before distribution

Lots that do not meet documented release criteria are not offered for sale and are handled under the non-conformance procedure in Section 10.

8. Storage, handling, and distribution

Products are stored under conditions appropriate to peptide reference materials, with access limited to authorized personnel. Fulfillment procedures verify order accuracy, lot association where applicable, and packaging integrity prior to shipment.

Distribution is limited to qualified research buyers. Caliber Labs reserves the right to verify purchaser eligibility in accordance with its Terms of Sale.

9. Documentation and records

Quality records include, as applicable:

• Supplier and receiving documentation
• Third-party analytical reports and COA files
• AuthentiChain certification and lot verification records
• Customer quality complaints and investigation notes
• CAPA and recall documentation

Records are retained for a minimum of three (3) years unless a longer period is required by law, customer agreement, or an active investigation.

10. Non-conformance, complaints, and CAPA

Any deviation from specified quality requirements, customer complaint, laboratory finding, or internal inspection failure is documented and reviewed by management.

Corrective and preventive action (CAPA) may include:

• Quarantine or hold of affected inventory
• Root-cause analysis
• Supplier or process corrective measures
• Customer notification when distributed product may be affected
• Initiation of recall per the Emergency Product Recall Procedure when warranted

11. Management review

This QA Plan is reviewed at least annually and updated when operations, suppliers, testing methods, or regulatory expectations change. Version history is maintained by Caliber Labs management.