UNIT 7: Post-Approval & Lifecycle Management
This unit explains how approved pharmaceutical products are managed throughout their lifecycle after market authorization. It covers types of variations, SUPAC concepts, risk-based change management, and global post-approval strategies.
Definition
Post-approval lifecycle management refers to the regulatory control of changes made to an approved pharmaceutical product to ensure continued quality, safety, and efficacy throughout its market life.
Regulators recognize that changes are inevitable after approval. However, all changes must be scientifically justified, risk-assessed, and reported through appropriate regulatory pathways and systematically handled by change control
Key Points
Approval is not the end of regulatory oversight
Changes must be managed through defined variation pathways Change control
Poor change management can lead to compliance actions
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