Change Management is a critical quality system during the drug development and commercial phase of a pharmaceutical product. Post-approval changes are first categorized as minor, moderate and major based on product quality, product efficacy and patient safety risk. The second is risk-based categorization of regulatory communication as prior approval supplement (PAS) or notification. Any changes to established conditions (EC) in common technical document (CTD) necessitates submission to regulatory authority as PAS or notification.
An effective change management system requires processes for science-based risk assessment and categorization of proposed change, approval by all impacted stakeholders, implementation as per approved protocol and post-implementation verification for unintended consequences, including the risk management if change is not implemented.
Several regulatory guidance???s including recently published ICH Q12 Draft guidance, provides risk-based approach for implementation of post approval CMC changes.