Module 3 - Strategic case studies in practice

A PPENDIX 2: P RINCIPLES OF C HANGE M ANAGEMENT Consistent with the basic requirements of ICH Q10, an effective change management system supports the principles of this guideline and is described below: 1. Captures stimuli for change, including those that can improve product performance or process robustness; 2. Ensures full understanding of the scope of the change and its implications for all aspects of the process and control strategy including the impact on ECs and aspects that are not ECs in affected marketing authorisations; 3. Leverages existing process performance and product quality knowledge; 4. Requires science-based risk management and risk categorisation of the intended change; considers the potential impact if the intended change is not implemented; 5. Determines data (existing and/or to be newly generated) needed to support the change and accordingly develops study protocols describing the methods, prospective acceptance criteria as well as additional post-implementation process performance and/or product quality monitoring as necessary; 6. Ensures that an appropriate regulatory submission is filed when required; 7. Uses a defined change control process to approve or reject the intended change and involve appropriate stakeholders, including but not restricted to Manufacturing, Quality, and Regulatory Affairs personnel; 8. Ensures implementation of the change is based on: a. Review that the change as implemented remains aligned with the relevant study protocols, PLCM document, or PACMP; b. Assessment of data generated to demonstrate that the change objective and acceptance criteria were met; 9. Ensures that risk-mitigating steps are developed in the case of deviations from acceptance criteria, or identification of unanticipated risks; 10. Verifies, post-implementation, that relevant changes have been effective in achieving the desired outcome with no unintended consequences for product quality; If deviations associated with post-approval changes are detected, ensures that the issue is managed via the company’s deviation management process and appropriate corrective and/or preventive actions are identified and undertaken via the company’s corrective and preventive action (CAPA) system; 11. Post-implementation: a. Captures new product/process knowledge gained during implementation of the change;

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