Comment from Padagis LLC
AnonymousSupportOther
Summary: The commenter provides technical feedback on the proposed SUPAC-SS Guidance. They suggest including references to level 1 drug substance changes, such as supplier changes, and updating the IVRT section to reference USP <1724>.
Comments regarding SUPAC-SS Guidance:
1. There is a lack of reference in the current guidance to changes in the drug substance that are considered as level 1 (for example, a change in the supplier of the active substance without changes of its polymorph and particle size distribution).
2. The IVRT section in the current guide is outdated; it is possible to refer to USP <1724>.