Supplier Qualification Audit

This Supplier Qualification Audit template helps organizations evaluate and approve vendors against current Good Manufacturing Practice requirements and 21 CFR 111. It covers company information, certifications, regulatory registrations, and the structure of QA and QC. The checklist spans pest control, SOPs, cleaning, preventive maintenance, employee training, quarantine procedures, lot and batch traceability, line clearance, labeling, warehouse and distribution controls, and complaint handling. It also addresses in house and external laboratory controls, method validation, calibration and maintenance, retain samples, COAs, and internal quality audits. A facility walk through guides checks across receiving, warehouse, weighing, blending and compounding, tableting and coating, packaging, maintenance, and labs to ensure consistent compliance and product quality.