Supplier Audit Checklist - Comprehensive Evaluation

Assessment Overview

This 50-point audit checklist provides a systematic framework for evaluating peptide suppliers across five critical domains. Each criterion includes specific verification methods and scoring guidelines to ensure objective, repeatable assessments. Use this checklist to compare suppliers, identify risks, and make data-driven sourcing decisions.

Scoring System

Total Points Available: 50

  • 45-50 points: Excellent - Tier 1 supplier, minimal risk
  • 38-44 points: Good - Tier 2 supplier, acceptable with monitoring
  • 30-37 points: Fair - Tier 3 supplier, significant concerns
  • Below 30 points: Poor - Do not recommend for sourcing

Section 1: Business Legitimacy (10 Points)

Verify the supplier operates as a legitimate, registered business entity with proper documentation and regulatory compliance.

1. Company Registration & Legal Status (2 points)

Criteria: Supplier provides verifiable business registration documents including company number, registered address, and incorporation date.

Verification Method:

  • Request certificate of incorporation or equivalent
  • Verify registration with local business registry
  • Confirm registered address matches operational address
  • Check company age and ownership structure

Scoring:

  • 2 points: Complete documentation provided, all details verified
  • 1 point: Documentation provided but contains inconsistencies
  • 0 points: No documentation or unverifiable information

2. Business License & Operating Permits (2 points)

Criteria: Supplier holds current licenses required for manufacturing or distributing peptides in their jurisdiction.

Verification Method:

  • Request copies of pharmaceutical/chemical business licenses
  • Verify license numbers with issuing authorities
  • Confirm licenses are current and not expired
  • Check for any violations or sanctions

Scoring:

  • 2 points: All required licenses current and verified
  • 1 point: Licenses provided but approaching expiration or minor gaps
  • 0 points: Missing critical licenses or expired documentation

3. Tax Documentation & Financial Standing (1 point)

Criteria: Supplier provides tax registration numbers and demonstrates financial stability.

Verification Method:

  • Obtain VAT/tax registration number
  • Request recent financial statements or credit references
  • Check for bankruptcy filings or legal judgments
  • Verify payment terms and financial capacity

Scoring:

  • 1 point: Tax documentation provided, financial standing verified
  • 0 points: Cannot verify tax status or financial concerns identified

4. Physical Facility Verification (2 points)

Criteria: Supplier operates from a verifiable physical location with legitimate manufacturing or distribution facilities.

Verification Method:

  • Verify address through satellite imagery and street view
  • Conduct phone verification of listed contact numbers
  • Request facility photos showing signage and equipment
  • Arrange virtual or in-person facility tour if possible

Scoring:

  • 2 points: Facility verified with photographic evidence or site visit
  • 1 point: Address verified but limited visual confirmation
  • 0 points: Cannot verify physical location or virtual office detected

5. Industry Tenure & Track Record (1 point)

Criteria: Supplier demonstrates established presence in peptide industry with verifiable history.

Verification Method:

  • Verify years in operation (minimum 2 years preferred)
  • Check for consistent online presence and archive history
  • Request customer references or testimonials
  • Search for industry recognition or certifications

Scoring:

  • 1 point: 2+ years verified operation with consistent track record
  • 0 points: New operation or gaps in business history

6. Regulatory Compliance History (2 points)

Criteria: Supplier has clean regulatory record with no significant violations or warning letters.

Verification Method:

  • Search FDA warning letters database (if applicable)
  • Check local regulatory authority records
  • Review any inspection reports or compliance certificates
  • Verify no active legal proceedings related to product quality

Scoring:

  • 2 points: Clean compliance record with no violations
  • 1 point: Minor violations fully resolved or corrected
  • 0 points: Active violations or serious compliance history

Section 2: Quality Systems (15 Points)

Evaluate the supplier's quality management infrastructure, manufacturing standards, and commitment to product quality.

7. GMP Certification Status (3 points)

Criteria: Supplier maintains current Good Manufacturing Practice certification from recognized certifying body.

Verification Method:

  • Request copies of GMP certificates (cGMP, EU GMP, or equivalent)
  • Verify certificate authenticity with issuing organization
  • Check certification scope covers peptide manufacturing
  • Confirm certification is current and not expired

Scoring:

  • 3 points: Current cGMP or equivalent certification verified
  • 2 points: GMP certification in progress or regional equivalent
  • 1 point: Quality management system exists but not certified
  • 0 points: No GMP system or certification

8. ISO Quality Certifications (2 points)

Criteria: Supplier holds relevant ISO certifications demonstrating systematic quality management.

Verification Method:

  • Request ISO 9001, ISO 13485, or ISO 17025 certificates
  • Verify certificates with issuing certification body
  • Check scope of certification covers relevant activities
  • Review any audit reports or nonconformances

Scoring:

  • 2 points: Multiple relevant ISO certifications verified
  • 1 point: Single ISO certification verified
  • 0 points: No ISO certifications

9. Quality Management Documentation (2 points)

Criteria: Supplier maintains comprehensive quality management system with documented procedures.

Verification Method:

  • Request quality manual or QMS overview
  • Review standard operating procedures (SOPs) for critical processes
  • Verify document control and revision procedures
  • Check for batch record systems and traceability procedures

Scoring:

  • 2 points: Comprehensive QMS with detailed documentation
  • 1 point: Basic quality procedures documented
  • 0 points: No documented quality system

10. Raw Material Sourcing Controls (2 points)

Criteria: Supplier implements supplier qualification and raw material testing protocols.

Verification Method:

  • Request description of supplier qualification process
  • Review raw material specifications and acceptance criteria
  • Verify incoming material testing procedures
  • Check for certificate of analysis requirements from sub-suppliers

Scoring:

  • 2 points: Formal supplier qualification with incoming material testing
  • 1 point: Basic incoming material verification
  • 0 points: No documented raw material controls

11. Manufacturing Process Controls (2 points)

Criteria: Supplier employs validated manufacturing processes with documented controls.

Verification Method:

  • Request process flow diagrams for peptide synthesis
  • Review critical process parameters and control limits
  • Verify process validation documentation
  • Check for in-process testing and quality checkpoints

Scoring:

  • 2 points: Validated processes with comprehensive controls
  • 1 point: Documented processes with basic controls
  • 0 points: No documented process controls

12. Equipment Calibration & Maintenance (1 point)

Criteria: Supplier maintains calibrated, properly maintained analytical and manufacturing equipment.

Verification Method:

  • Request equipment list with calibration schedules
  • Review recent calibration certificates
  • Verify preventive maintenance programs
  • Check equipment qualification documentation

Scoring:

  • 1 point: Current calibration and maintenance records provided
  • 0 points: No calibration program or outdated records

13. Environmental Controls (1 point)

Criteria: Supplier maintains appropriate environmental conditions for peptide manufacturing and storage.

Verification Method:

  • Request environmental monitoring data (temperature, humidity)
  • Review cleanroom classifications if applicable
  • Verify storage condition controls (refrigeration, desiccation)
  • Check for environmental monitoring procedures

Scoring:

  • 1 point: Documented environmental controls with monitoring data
  • 0 points: No documented environmental controls

14. Deviation & CAPA System (1 point)

Criteria: Supplier implements formal deviation management and corrective/preventive action systems.

Verification Method:

  • Request examples of deviation investigations
  • Review CAPA procedures and recent examples
  • Verify root cause analysis methodology
  • Check for trending and continuous improvement activities

Scoring:

  • 1 point: Formal deviation and CAPA system with documentation
  • 0 points: No systematic deviation management

15. Training & Personnel Qualification (1 point)

Criteria: Supplier maintains qualified personnel with documented training programs.

Verification Method:

  • Request information on key personnel qualifications
  • Review training program overview
  • Verify GMP training for manufacturing staff
  • Check for competency assessment procedures

Scoring:

  • 1 point: Qualified personnel with documented training program
  • 0 points: No documented training or qualification system

Section 3: Testing & Documentation (10 Points)

Assess the supplier's analytical testing capabilities, documentation practices, and commitment to product verification.

16. In-House Testing Capabilities (2 points)

Criteria: Supplier operates analytical laboratory with peptide testing equipment.

Verification Method:

  • Request laboratory equipment list
  • Verify presence of HPLC, mass spectrometry, or equivalent
  • Review laboratory floor plan or photos
  • Check analyst qualifications and training

Scoring:

  • 2 points: Comprehensive in-house testing with advanced equipment
  • 1 point: Basic testing capabilities, some outsourcing
  • 0 points: No in-house testing or all testing outsourced

17. Certificate of Analysis Quality (3 points)

Criteria: Supplier provides detailed, comprehensive certificates of analysis for every batch.

Verification Method:

  • Request sample CoA for review
  • Verify CoA includes all critical quality attributes (purity, identity, content)
  • Check for appropriate test methods referenced
  • Confirm batch-specific data (not generic template)
  • Verify authorized signatures and dates

Scoring:

  • 3 points: Comprehensive CoA with complete testing panel and method details
  • 2 points: Adequate CoA covering major quality attributes
  • 1 point: Basic CoA with limited testing data
  • 0 points: No CoA or generic template without batch data

18. Third-Party Testing Acceptance (2 points)

Criteria: Supplier accepts and facilitates third-party testing verification.

Verification Method:

  • Request supplier policy on third-party testing
  • Verify willingness to provide retain samples
  • Check for additional fees or restrictions
  • Confirm responsiveness if discrepancies identified

Scoring:

  • 2 points: Actively encourages third-party testing, provides samples
  • 1 point: Accepts third-party testing but with limitations
  • 0 points: Refuses or heavily restricts third-party testing

19. Test Method Validation (1 point)

Criteria: Supplier uses validated analytical methods appropriate for peptide testing.

Verification Method:

  • Request analytical method descriptions or references
  • Verify methods are pharmacopeial or validated
  • Review method validation documentation if available
  • Check for appropriate specificity and sensitivity

Scoring:

  • 1 point: Validated methods with documentation provided
  • 0 points: No method validation or inappropriate methods

20. Batch Traceability & Documentation (1 point)

Criteria: Supplier maintains complete batch records with full traceability.

Verification Method:

  • Request example batch record or manufacturing record
  • Verify batch numbering system and traceability
  • Check for raw material lot tracking
  • Confirm document retention policies

Scoring:

  • 1 point: Complete batch documentation with full traceability
  • 0 points: Inadequate batch records or poor traceability

21. Stability Testing Program (1 point)

Criteria: Supplier conducts stability testing to support expiry dating and storage recommendations.

Verification Method:

  • Request stability study protocols or summaries
  • Verify real-time or accelerated stability data
  • Check storage condition recommendations based on data
  • Confirm expiry dates are supported by testing

Scoring:

  • 1 point: Documented stability program with data supporting claims
  • 0 points: No stability testing or unsupported expiry dates

Section 4: Operations & Logistics (8 Points)

Evaluate supplier's operational capabilities, shipping practices, and ability to deliver products reliably.

22. Inventory Management System (1 point)

Criteria: Supplier maintains organized inventory with stock tracking and availability visibility.

Verification Method:

  • Assess stock availability information on website or quote
  • Request information on inventory management practices
  • Verify ability to provide lead time estimates
  • Check for first-expiry-first-out (FEFO) practices

Scoring:

  • 1 point: Organized inventory system with transparent availability
  • 0 points: Poor inventory visibility or frequent stockouts

23. Cold Chain Management (2 points)

Criteria: Supplier implements proper cold chain procedures for temperature-sensitive peptides.

Verification Method:

  • Request cold chain shipping procedures
  • Verify use of validated shippers or cold packs
  • Check for temperature monitoring during transit
  • Review cold storage capabilities at warehouse

Scoring:

  • 2 points: Comprehensive cold chain with validated shippers and monitoring
  • 1 point: Basic cold chain procedures with ice packs
  • 0 points: No cold chain capabilities or unreliable practices

24. Packaging Quality & Protection (1 point)

Criteria: Supplier uses appropriate packaging to protect peptides from degradation and damage.

Verification Method:

  • Review packaging materials and methods
  • Verify use of desiccants for moisture-sensitive products
  • Check for light protection (amber vials, foil)
  • Assess adequacy of outer shipping containers

Scoring:

  • 1 point: Appropriate packaging with protective measures
  • 0 points: Inadequate packaging or poor protection

25. Shipping Speed & Reliability (2 points)

Criteria: Supplier demonstrates reliable, timely shipping with multiple carrier options.

Verification Method:

  • Review stated processing and shipping timeframes
  • Check carrier options available (express, economy)
  • Verify international shipping capabilities if needed
  • Assess customer feedback on delivery performance

Scoring:

  • 2 points: Fast processing (1-3 days), multiple carrier options, reliable
  • 1 point: Moderate processing times, limited carrier options
  • 0 points: Slow processing or unreliable delivery

26. Customs & Import Documentation (1 point)

Criteria: Supplier provides proper customs documentation for international shipments.

Verification Method:

  • Request sample commercial invoice
  • Verify provision of certificates (CoA, CoO, etc.)
  • Check harmonized tariff code accuracy
  • Assess experience with destination country requirements

Scoring:

  • 1 point: Complete, accurate customs documentation provided
  • 0 points: Incomplete or inaccurate documentation

27. Order Tracking & Communication (1 point)

Criteria: Supplier provides tracking information and proactive shipment updates.

Verification Method:

  • Verify provision of tracking numbers
  • Check for shipment notifications (order confirmation, shipping alert)
  • Assess accessibility of order status information
  • Review customer feedback on communication

Scoring:

  • 1 point: Proactive communication with tracking information
  • 0 points: Poor communication or no tracking provided

Section 5: Customer Service (7 Points)

Assess supplier's customer support capabilities, responsiveness, and commitment to customer satisfaction.

28. Pre-Sales Technical Support (1 point)

Criteria: Supplier provides knowledgeable technical assistance during inquiry and ordering process.

Verification Method:

  • Test responsiveness with technical questions
  • Assess quality and accuracy of technical information provided
  • Verify availability of scientific staff for consultation
  • Check for product selection guidance and recommendations

Scoring:

  • 1 point: Knowledgeable, responsive technical support available
  • 0 points: Limited technical knowledge or poor responsiveness

29. Communication Responsiveness (2 points)

Criteria: Supplier responds promptly to inquiries through multiple communication channels.

Verification Method:

  • Test response time to email inquiries (benchmark: 24-48 hours)
  • Verify availability of phone support and response quality
  • Check for live chat or alternative contact methods
  • Assess quality and completeness of responses

Scoring:

  • 2 points: Responds within 24 hours, multiple channels, high quality
  • 1 point: Responds within 48 hours, limited channels, adequate quality
  • 0 points: Slow response (>72 hours) or poor communication

30. Custom Synthesis Capabilities (1 point)

Criteria: Supplier offers custom peptide synthesis services with clear processes.

Verification Method:

  • Request information on custom synthesis capabilities
  • Verify scale options (mg to gram scale)
  • Check turnaround time and pricing transparency
  • Assess modification options (labeling, conjugation)

Scoring:

  • 1 point: Custom synthesis available with clear process and pricing
  • 0 points: No custom synthesis or unclear capabilities

31. Return & Complaint Handling (1 point)

Criteria: Supplier maintains clear policies for handling returns, complaints, and product issues.

Verification Method:

  • Review return policy and conditions
  • Verify complaint handling procedures
  • Check for quality guarantee or satisfaction policy
  • Assess customer feedback on issue resolution

Scoring:

  • 1 point: Clear return policy with responsive complaint handling
  • 0 points: No return policy or poor complaint resolution

32. Payment Options & Terms (1 point)

Criteria: Supplier offers multiple payment methods with reasonable terms.

Verification Method:

  • Verify accepted payment methods (credit card, wire, purchase order)
  • Check for account terms availability
  • Review payment security measures
  • Assess pricing transparency and quote validity

Scoring:

  • 1 point: Multiple payment options with secure processing
  • 0 points: Limited payment options or security concerns

33. Customer Reputation & Reviews (1 point)

Criteria: Supplier maintains positive reputation with verifiable customer feedback.

Verification Method:

  • Search for independent customer reviews and testimonials
  • Check scientific forums and research communities
  • Verify Better Business Bureau or equivalent ratings
  • Request customer references if available

Scoring:

  • 1 point: Positive reputation with verifiable reviews
  • 0 points: Negative reviews or no verifiable feedback

Comprehensive Scoring Guide

Score Interpretation

Tier 1: Excellent (45-50 points)

Risk Level: Minimal

Recommendation: Approved for immediate sourcing with standard oversight

Characteristics:

  • Fully documented business legitimacy with all licenses current
  • GMP certified with comprehensive quality systems
  • Advanced testing capabilities with detailed CoAs
  • Reliable logistics with validated cold chain
  • Excellent customer service and communication

Monitoring Requirements: Annual re-audit, routine CoA review, quarterly performance evaluation

Tier 2: Good (38-44 points)

Risk Level: Low to Moderate

Recommendation: Approved for sourcing with enhanced verification

Characteristics:

  • Verified business legitimacy with minor documentation gaps
  • Quality systems in place, may lack formal certifications
  • Adequate testing with acceptable CoAs
  • Reliable operations with occasional issues
  • Responsive customer service

Monitoring Requirements: Semi-annual re-audit, mandatory third-party testing for initial orders, detailed CoA review, monthly performance tracking

Tier 3: Fair (30-37 points)

Risk Level: Moderate to High

Recommendation: Use only with significant risk mitigation measures

Characteristics:

  • Basic business documentation with some verification challenges
  • Limited quality systems or unverified certifications
  • Basic testing capabilities with inconsistent documentation
  • Operational inconsistencies or reliability concerns
  • Acceptable but not exceptional customer service

Monitoring Requirements: Quarterly re-audit, mandatory third-party testing for every batch, enhanced batch documentation review, alternative supplier identification

Below Tier 3: Poor (Below 30 points)

Risk Level: Unacceptable

Recommendation: Do not source - seek alternative suppliers

Characteristics:

  • Cannot verify business legitimacy or significant red flags
  • No credible quality systems or certifications
  • Inadequate or absent testing documentation
  • Poor operational reliability
  • Unresponsive or inadequate customer service

Action: Disqualify supplier and remove from approved vendor list

Critical Failure Criteria

Regardless of overall score, automatically disqualify suppliers with any of the following:

  • Cannot verify physical business location (Score 0 on Item 4)
  • Active regulatory violations or warning letters (Score 0 on Item 6)
  • Refuses third-party testing (Score 0 on Item 18)
  • No certificate of analysis provided (Score 0 on Item 17)
  • Evidence of fraudulent documentation or misrepresentation

Using This Checklist Effectively

Initial Assessment: Complete all 33 items during supplier qualification process before placing first order.

Documentation: Retain all verification documents, correspondence, and evidence supporting each score.

Re-Assessment: Re-audit suppliers annually or when significant changes occur (ownership, location, certifications).

Comparative Analysis: Use identical scoring criteria when comparing multiple suppliers for same peptide.

Continuous Improvement: Track supplier scores over time and work with suppliers to address deficiencies.

Section-Specific Benchmarks

Section Maximum Points Minimum Acceptable Target Score
Business Legitimacy 10 7 9+
Quality Systems 15 10 12+
Testing & Documentation 10 7 8+
Operations & Logistics 8 5 6+
Customer Service 7 4 5+
TOTAL 50 33 40+

Red Flags and Warning Signs

Beyond numerical scores, watch for these qualitative red flags that should raise concerns:

  • Evasiveness: Supplier avoids answering specific questions or providing requested documentation
  • Inconsistencies: Information provided conflicts with public records or website claims
  • Pressure Tactics: Supplier rushes decision-making or discourages due diligence
  • Price Anomalies: Pricing significantly below market without credible explanation
  • Limited Transparency: Reluctance to discuss manufacturing processes or quality systems
  • Poor Communication: Unprofessional correspondence or language barriers affecting technical understanding
  • Unverifiable Claims: Cannot substantiate certifications, capabilities, or customer references
  • Website Red Flags: Recently created domain, copied content, or unprofessional presentation

Documentation Requirements

Maintain a supplier qualification file containing:

  • Completed audit checklist with scores and dates
  • All supporting documentation requested during audit
  • Verification records (certificate confirmations, reference checks)
  • Communication records and technical correspondence
  • Sample CoAs and product specifications
  • Any third-party testing results obtained
  • Performance monitoring data (delivery times, complaint records)
  • Re-audit records showing score trends over time

Risk-Based Approach

Weight audit criteria based on peptide application:

Research Use: Emphasize testing documentation (Section 3) and product quality over operational speed

Clinical/Therapeutic Use: Require maximum scores in Quality Systems (Section 2) and Business Legitimacy (Section 1)

High-Value Orders: Prioritize suppliers scoring 42+ with verified GMP certification

Routine/Low-Risk Peptides: May accept Tier 2 suppliers (38+) with third-party testing verification

Implementation Protocol

Deploy this checklist as part of a structured supplier qualification program:

  1. Desktop Audit: Complete all checklist items that can be verified remotely through documentation review and online verification
  2. Reference Checks: Contact provided references and search for independent customer feedback
  3. Sample Order: Place small test order to evaluate actual performance against documented claims
  4. Third-Party Testing: Submit sample order products for independent laboratory analysis
  5. Performance Correlation: Compare actual results to audit scores and adjust scoring if needed
  6. Final Approval: Make sourcing decision based on total score, section scores, and verification results

This comprehensive 50-point audit checklist provides the systematic framework necessary to evaluate peptide suppliers objectively and identify reliable sources. By scoring suppliers across business legitimacy, quality systems, testing capabilities, operations, and customer service, you create a quantifiable basis for vendor selection and risk management.

Remember that supplier qualification is not a one-time event. Continuous monitoring and periodic re-auditing ensure that approved suppliers maintain the standards that qualified them initially. Use this checklist as a living document, updating scores as new information becomes available and supplier performance evolves.

The most important principle: never compromise on critical quality and legitimacy factors regardless of price or convenience. A low-scoring supplier offering significant discounts represents higher total cost when factoring risks of poor quality, regulatory issues, or product failures. Invest time in thorough supplier evaluation upfront to avoid costly problems downstream.