Redefinition of Starting Materials - How to deal with it?
Definition of Starting Materials is a subject that concerns all API manufacturers and is an important key for success of an API and its life cycle.
API synthetic routes with many steps carried out under GMP conditions are normally easily accepted by regulatory authorities.
However, the maintenance of its documentation especially due to potential changes involves significant workload for Regulatory Affairs and QM divisions of all companies, not to mention the costs linked to such long processes under GMP.
Defining later substances as starting materials involves very complex studies of the concerned earlier steps, but the learnings from such studies are paid off by strong reduction of future workload.
Midas has been working with quite complex starting materials and compiling together with our manufacturing partners the necessary documents to prove their definition as such and demonstrating Regulatory Authorities their suitability.
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