Science- and Risk-Based Stability Strategies to Support Product Lifecycle Changes.

Area of Science:

• Pharmaceutical Science
• Regulatory Science

Background:

• ICH Q12 guidance supports science- and risk-based approaches for post-approval changes (PAC) in Chemistry, Manufacturing, and Controls (CMC).
• Lack of specific examples hinders the application of prior knowledge in risk assessments for CMC PAC.

Purpose of the Study:

• To demonstrate the application of science- and risk-based stability strategies for CMC PAC.
• To illustrate how prior knowledge can inform risk assessments for product lifecycle management.

Main Methods:

• Presentation of ten diverse case studies involving drug substance and product CMC PAC.
• Utilizing accumulated stability knowledge from original manufacturers to assess change impact.

Main Results:

• Successfully supported drug substance and product CMC PAC using science- and risk-based stability strategies.
• Demonstrated effective risk assessment and confident change management through leveraging prior knowledge.

Conclusions:

• Science- and risk-based stability strategies are effective for CMC PAC and lifecycle management.
• Leveraging prior knowledge can lead to reduced stability data commitments and reporting categories for PAC.