Abstract
It is important to identify, assess, and address current barriers to implementation of post-approval changes that are intended to ensure continued (uninterrupted) operations and drive innovation and continual improvement in a maximally efficient, agile, and flexible pharmaceutical manufacturing sector. Leveraging the International Conference for Harmonisation Quality Guideline Q10 provides regulatory relief when it comes to addressing changes related to excipients, specifically excipient supplier's name and address changes, which will ensure a sustainable, reliable global supply and the availability of high quality product to patients through the entire commercial lifecycle of a product without extensive regulatory oversight.
- Regulatory
- Chemistry, Manufacturing and Controls (CMC)
- International Conference for Harmonisation (ICH) Q10
- Pharmaceutical quality system (PQS)
- Post-approval change (PAC)
- Excipient supplier name changes
- Risk Implementation
- Quality risk management
- Regulatory relief
Footnotes
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