Supplier Qualification & Auditing

Supplier Qualification and Auditing. The Manufacturer shall maintain a documented supplier qualification program that ensures all suppliers and sub-suppliers of raw materials, components, and services meet the quality and regulatory requirements established under this Agreement. Supplier qualification shall include, at a minimum: (a) initial assessment through a supplier qualification questionnaire and documentation review; (b) an on-site audit prior to approval for critical material suppliers; (c) evaluation of the supplier's quality management system, including ISO or cGMP certifications; (d) review and approval of certificates of analysis (CoA) and certificates of conformance (CoC) for all incoming materials; and (e) ongoing monitoring through periodic re-audits, performance scorecards, and trend analysis of incoming material quality. The Client reserves the right to audit the Manufacturer's suppliers upon reasonable notice. Any supplier found to be non-compliant shall be placed on probation or disqualified, with a corrective action plan required before reinstatement.