Industry One-Voice-of-Quality (1VQ) Solutions: Effective Management of Post-Approval Changes in the Pharmaceutical...

Area of Science:

• Pharmaceutical Quality Systems
• Regulatory Affairs
• Drug Manufacturing

Background:

• Post-approval changes are essential for drug lifecycle management, incorporating new knowledge and ensuring product quality.
• Global regulatory complexities significantly delay the implementation of necessary drug product changes, impacting patient safety and supply.
• Manufacturers face substantial operational risks due to the intricate and time-consuming nature of worldwide post-approval change management.

Purpose of the Study:

• To address the global challenge of managing post-approval changes in the pharmaceutical industry.
• To propose two standardized solutions for effective pharmaceutical quality system (PQS) management of post-approval changes.
• To foster an aligned industry position on leveraging a risk-based approach for post-approval changes, guided by ICH Q10 Annex 1.

Main Methods:

• Collaboration among senior quality leaders from over 20 global pharmaceutical companies under the "One-Voice-Of-Quality" (1VQ) initiative.
• Development of a standardized approach for establishing and demonstrating an effective PQS for managing post-approval changes.
• Leveraging a risk-based approach as outlined in ICH Q10 Annex 1 for change management.

Main Results:

• Two specific solutions are presented to facilitate an aligned and standardized industry approach to post-approval change management.
• The proposed solutions aim to streamline the implementation of changes, reducing delays and associated risks.
• The initiative seeks to enable faster adoption of new knowledge and drive continual improvement in drug manufacturing.

Conclusions:

• Implementing the proposed solutions can lead to a significant shift towards more efficient and effective post-approval change management.
• This collaborative effort, represented by 1VQ, provides a foundation for industry-wide standardization.
• The paper invites further participation from pharmaceutical companies and stakeholders to advance the dialogue on optimizing PQS for post-approval changes.