Manufacturing & Analytical Characterization – Biomolecular
Christine Moore, PhD
Executive Director
Organon
Lansdale, Pennsylvania
The regulatory landscape for analytical procedures is evolving. The recently released drafts of ICH Q2(R2) on analytical procedure validation and ICH Q14 on analytical procedure development strive to modernize regulatory expectations. Furthermore, the upcoming revisions of ICH Q6A & Q6B hold promise to refocus specification setting away from historical capability and toward patient needs. These regulatory changes, coupled with capabilities of new analytical technology, have the potential to greatly revolutionize the manufacturing and testing approaches of tomorrow. This presentation will explore the changes in the regulatory landscape for analytical procedures and potential opportunity and challenges for adopting these changes for the globally regulated pharmaceutical industry.