Best Regulatory Practices For Lifecycle Management – Registration Of Manufacturing Controls

When it comes to manufacturing control strategies, organizations often face a trade-off between tradition and flexibility. A tightly controlled approach—where the process is repeated exactly as registered—offers predictability but limits adaptability. In contrast, a Quality by Design (QbD) strategy leverages deep process understanding to build in flexibility, especially when navigating post-approval changes. While QbD can demand more upfront investment in time and resources, it can ultimately streamline regulatory interactions and reduce lifecycle variation categories. Drawing on real-world experience, BioPhorum member organizations share best practices for both initial submissions and post-approval changes, which offer a practical roadmap for implementing QbD tools effectively. This collection of insights is designed to help teams reduce regulatory burden, maintain supply continuity, and optimize product lifecycle management.

Explore how QbD can unlock smarter, more agile manufacturing strategies—without compromising compliance.