Ensuring supplier compliance with stringent regulatory standards is paramount. The Vendor Audit Checklist, serves as a critical tool for evaluating third-party manufacturers, especially in terms of Good Manufacturing Practices (GMP), quality assurance, and safety protocols.
Why Vendor Audits Matter
Vendor audits help pharmaceutical companies:
- Mitigate supply chain risks
- Ensure product consistency
- Verify regulatory compliance
- Strengthen customer confidence
Whether you are sourcing APIs, excipients, or packaging materials, this checklist ensures your vendors are aligned with international quality benchmarks like ISO 9001/14001 and RoHS (Restriction of Hazardous Substances).
Key Sections of the Vendor Audit Checklist
1. General Information
This section gathers basic but vital data—such as material codes, manufacturing addresses, QA contacts, and lead times.
2. Organizational Structure
Auditors examine the vendor’s hierarchy, including roles of the Managing Director, Plant Manager, and QA/QC Heads, to assess leadership and accountability.
3. Facility Certification
Checkpoints include verification of ISO certifications, segregation of manufacturing lines (especially for sensitive drugs like cephalosporins), and product traceability.
4. Warehouse Management
Key audit points:
- SOP adherence
- FIFO system
- Labeling accuracy
- Pest control and cleanliness
- Inventory tracking and rejected material handling
5. Production Oversight
The checklist evaluates
- Batch processing protocols
- Equipment validation and calibration
- Cross-contamination prevention
- Training logs and production record documentation
6. Quality Control
It covers:
- OOS (Out-of-Specification) procedures
- In-process and final product testing
- Sample retention and specification approval
- Stability studies and working standards
7. Quality Assurance
Critical QA controls include
- Change control management
- Internal audit schedules
- Complaint handling and CAPA (Corrective and Preventive Actions)
- Annual Product Reviews
8. RoHS Compliance
For manufacturers of electronic pharma components, compliance with the EU’s RoHS directive is mandatory. The checklist ensures no prohibited substances like lead, mercury, or cadmium are used.
Final Evaluation and Recommendations
The checklist concludes with a summary section for audit remarks, recommendations, and sign-offs from both auditing and vendor personnel—ensuring a transparent and documented audit trail.
ALSO READ: SOP for Vendor Qualification and Approval
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