Pharmaceutical Supply Chain Management Audit Checklist

This checklist covers all major aspects of the pharmaceutical supply chain, including supplier qualification and management, raw material sourcing, warehousing and storage conditions, transportation and logistics, quality agreements, and end-to-end product traceability.

The frequency of supply chain audits can vary based on risk assessment and regulatory requirements. Generally, a comprehensive audit should be conducted annually, with more frequent assessments of high-risk suppliers or critical supply chain components.

These audits are usually conducted by a cross-functional team including quality assurance professionals, supply chain managers, procurement specialists, and regulatory affairs experts. External auditors may also be engaged for independent assessments.

The checklist includes verification of supplier authenticity, assessment of security measures in transportation and storage, evaluation of track-and-trace systems, and review of documentation practices, all of which contribute to detecting and preventing counterfeit products from entering the supply chain.

Yes, this checklist is designed to be adaptable for both local and global supply chains. It includes considerations for international regulations, cross-border transportation, and varying regional requirements, making it suitable for multinational pharmaceutical operations.