(189c) Application of Life-Cycle Concepts in Drug Substance Manufacturing

1. ICH Q7, Q9, Q10, Q11 and PV guidance main points
2. Product lifecycle concept and its development through the years
3. Guidances are inter-related and how they work in tandem

The biopharmaceutical industry is eager to utilize these approaches, strategies and tools. Therefore, drug manufacturers and industry professionals must thoroughly understand how QbD based development, Process Validation, Continued Process Verification and other regulatory commitments are inter related to achieve seamless lifecycle management. Limited maturity in an organization in any of these segments across development to commercialization may cause compliance and quality failures.

The participants will understand the International Council on Harmonisation (ICH) Q8 and Quality by Design (QbD) requirements, developing design space, requirements for Product Control Strategy and Established Conditions. They will have an overview of recognize the product lifecycle concept and its development through the years. Provide clarity on how guidances are inter-related and how they work in tandem. A systematic product lifecycle management approach is essential for effective drug substance development, continuous improvement and maintaining an undisrupted drug product supply.

This session will provide an understanding of the current lifecycle-related drug substance guidance and how they work in tandem to achieve the desired outcomes regulators expect. Defining and applying the concepts right first time is important. The science and data driven approach promotes innovation and continual industry improvement while strengthening quality assurance and improving essential drug products’ supply.