Industry One-Voice-of-Quality Solutions Management Review of Post-Approval Changes Guide.

Area of Science:

• Pharmaceutical quality systems
• Regulatory affairs
• Drug manufacturing

Background:

• Post-approval changes (PACs) are essential for drug product lifecycle management.
• Current regulatory complexities for PACs lead to multiple process versions and increased risk of drug shortages.
• Global pharmaceutical leaders united as One-Voice-of-Quality (1VQ) to address these challenges.

Purpose of the Study:

• To propose a science- and risk-based approach for managing PACs within the pharmaceutical quality system (PQS).
• To provide a practical guide for expanding management reviews (MR) to assess PQS effectiveness in handling PACs.
• To achieve greater regulatory flexibility and reduce reliance on prior approval supplements for certain PACs.

Main Methods:

• Leveraging existing International Conference on Harmonization (ICH) Q10 management review (MR) processes.
• Expanding MR to evaluate the PQS's capability in managing PACs.
• Developing and utilizing key performance indicators (KPIs) for assessing PAC management within the PQS.

Main Results:

• Demonstrates how expanded MR can assure effective PAC management within the PQS.
• Outlines specific PQS KPIs for monitoring PACs.
• Supports achieving regulatory flexibility as described in ICH Q10, Annex 1.

Conclusions:

• Effective PAC management within the PQS reduces the need for prior regulatory approval for low-risk changes.
• This approach enhances product availability and mitigates the risk of drug shortages.
• Facilitates timely innovation and continuous improvement in the pharmaceutical industry.