Module 3 2019

Starting materials: What’s the problem?

Major Objection: request to redefine regulatory SM to an earlier stage in the synthesis Regulator: Limited number of steps under GMP leads to concerns over insufficient control/regulatory oversight. ▪

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Applicant: Manufacturing decisions already taken – so problematic for applicant with respect to supply chain definition.

SM redefinition may translate to lengthy delays.

The Organisation for Professionals in Regulatory Affairs