Comment from Sartorius Corporation
AnonymousSupportBusiness
Summary: Sartorius, a manufacturer of tools and materials for drug and biological product manufacturing, provides specific technical feedback on the draft M4Q (R2) guidance. They request clarifications on implementation timelines, the handling of legacy products, and how the new structure supports cross-referencing independent master files for raw materials and intermediates.
Please see attached documentation for comments provided by Sartorius.