Checklist for Vendor Audits
Vendor Audit Checklist
1. General Information
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Vendor profile and organization structure available.
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Valid licenses, registrations, and certifications (GMP, ISO, GDP).
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Regulatory inspection history (FDA, EMA, WHO, local authorities).
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Change notification procedure in place.
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Approved supplier agreement/contract signed.
2. Quality Management System (QMS)
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Documented Quality Policy and QMS in place.
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SOPs available, current, and controlled.
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Internal audit program implemented with CAPAs.
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Management review meetings conducted with records.
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Deviation, CAPA, and change control procedures established.
3. Facilities & Premises
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Adequate facility design (segregated areas, unidirectional flow).
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Cleanliness, housekeeping, and pest control records.
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Environmental monitoring records (temperature, humidity, differential pressure).
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Utilities validated (water, compressed air, HVAC).
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Safety measures and emergency preparedness plans.
4. Equipment & Calibration
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Equipment qualification (IQ/OQ/PQ) records.
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Preventive maintenance schedules implemented.
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Calibration program established and up to date.
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Equipment cleaning and line clearance SOPs.
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Equipment logbooks maintained.
5. Raw Material Management
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Approved supplier list for critical raw materials and excipients.
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Material receipt, quarantine, approval, and rejection process.
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Sampling areas designed as per GMP requirements.
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Storage conditions monitored and controlled.
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Traceability maintained for all incoming raw materials.
6. Production & Process Control
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Batch Manufacturing Records (BMR) available and reviewed.
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Process validation and cleaning validation data.
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In-process control checks documented.
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Cross-contamination prevention measures implemented.
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Yield reconciliation performed at each stage.
7. Quality Control Laboratory
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Analytical method validation and verification records.
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Equipment calibration and qualification records.
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Stability studies data available (if applicable).
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Handling of OOS/OOT and deviation investigations.
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Data integrity controls (audit trails, ALCOA+ compliance).
8. Documentation & Data Integrity
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Controlled documentation system in place.
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Record retention policies established.
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Data integrity practices aligned with FDA/EMA guidance.
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Electronic system compliance with 21 CFR Part 11.
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Training on GDP/GMP for staff.
9. Training & Personnel
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Training records available for employees.
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Job descriptions and competency assessments documented.
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GMP, GDP, and safety training conducted.
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Personnel hygiene and medical fitness maintained.
10. Distribution & Supply Chain
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Packaging and labeling controls in place.
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Shipping conditions monitored (temperature-sensitive products).
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Traceability of shipments maintained.
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Returned/rejected/recalled products handled as per SOP.
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Contracted logistics service providers qualified.
11. Regulatory & Compliance
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Vendor compliant with applicable GMP, GDP, and pharmacopoeial requirements.
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Records of regulatory inspections and responses available.
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No history of data falsification, fraud, or blacklisting.
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Regulatory submissions updated (DMFs, CEPs, etc.).
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