Lifecycle Management (LCM) in the pharmaceutical industry refers to the systematic approach of managing a product from its development phase through commercialization, post-approval changes, and discontinuation. It ensures continuous product quality, compliance, and supply throughout its lifecycle.

Key Elements of Lifecycle Management:

1. Development Phase:

   • Formulation design, analytical method development, and process optimization.

   • Establishing control strategies and specifications.

2. Technology Transfer:

   • Ensuring consistent product performance during scale-up or site transfer.

   • Documentation and validation of manufacturing and analytical processes.

3. Commercialization Phase:

   • Continuous process verification (CPV).

   • Routine manufacturing under validated conditions.

4. Post-Approval Changes:

   • Managing variations (CMC changes) per regulatory guidelines (e.g., ICH Q12).

   • Continuous improvement based on process data and quality metrics.

5. Discontinuation Phase:

   • Proper documentation, stability data management, and batch record archiving.

ICH Reference:

• ICH Q12: Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management — provides a framework for managing post-approval CMC changes efficiently and predictably.

Objective:
To maintain a state of control and ensure product quality, safety, and efficacy throughout the product lifecycle.