Best Practices For The Development, Validation, And Registration Of Analytical Procedures - Implementation Of ICH Q2 (R2) And Q14 For Biologics

This ebook offers a practical framework for developing, validating, and registering analytical procedures in the biopharmaceutical space, with a strong focus on ICH Q2(R2) and Q14 implementation. It emphasizes the role of the Analytical Target Profile (ATP) in guiding technology selection and aligning procedures with critical quality attributes (CQAs). Readers will gain insight into applying Quality by Design (QbD) principles to analytical workflows, including risk assessment, parameter control, and lifecycle management. Explore phase-appropriate validation, robustness studies, and the use of prior knowledge and platform technologies, as well as clarity on the differences between development and commercial procedures.

Learn how to strengthen your analytical strategy.