Managing Excipient Supplier Name and Address Changes in the Pharmaceutical Quality System

Area of Science:

• Pharmaceutical Manufacturing
• Regulatory Science
• Supply Chain Management

Background:

• Current barriers hinder efficient implementation of post-approval changes in pharmaceutical manufacturing.
• Ensuring uninterrupted operations, innovation, and continuous improvement is vital for the sector.
• A flexible and agile manufacturing sector is essential for global health.

Purpose of the Study:

• To identify, assess, and address barriers to implementing post-approval changes in pharmaceutical manufacturing.
• To explore the benefits of leveraging the International Conference for Harmonisation Quality Guideline Q10 for regulatory relief.
• To ensure a sustainable and reliable global supply of high-quality pharmaceutical products.

Main Methods:

• Analysis of current barriers to post-approval change implementation.
• Application of the International Conference for Harmonisation Quality Guideline Q10 principles.
• Assessment of regulatory relief for excipient-related changes.

Main Results:

• Leveraging ICH Q10 provides significant regulatory relief for excipient supplier changes.
• This facilitates a sustainable and reliable global supply chain.
• Ensures the availability of high-quality products throughout the product lifecycle with reduced regulatory oversight.

Conclusions:

• Addressing implementation barriers and utilizing ICH Q10 streamlines pharmaceutical manufacturing.
• Excipient supplier changes can be managed efficiently, ensuring product quality and supply continuity.
• Regulatory flexibility supports innovation and maintains patient access to essential medicines.