Pharmaceutical Technology Transfer Audit Checklist

Technology transfer audits should be conducted at key stages of the transfer process, including pre-transfer assessment, during the transfer execution, and post-transfer verification. A final audit should be performed before the receiving site begins commercial production.

This checklist covers gap analysis between sending and receiving sites, process parameter evaluation, equipment qualification, analytical method transfer, batch record review, personnel training, risk assessment, and technology transfer documentation.

These audits are typically conducted by cross-functional teams including quality assurance specialists, process engineers, technology transfer managers, and subject matter experts from both sending and receiving sites.

The checklist ensures that all aspects of technology transfer meet regulatory standards, including process validation, analytical method transfer, and documentation practices, which are crucial for regulatory submissions and inspections.

If discrepancies are found, actions should include thorough investigation of the root cause, implementation of corrective measures, re-evaluation of affected processes or methods, additional training if necessary, and comprehensive documentation of all findings and actions taken.