The attempts to fit the intricacies of the science behind synthesis of APIs into the rigid boundaries of regulation have been more like the quintessential efforts of fitting a square peg into a round hole. The presentation attempts to provide a better understanding of complex topics such as why the same starting material may be acceptable for one route of manufacturing of the API and not another, how to apply the ICH M7 principles to the starting material selection, and the distinction between commercially available and custom-made starting materials. This presentation is informative and will be helpful for the industry in better selecting starting materials. For innovators, who can finalize their regulatory starting materials through meetings with the Agency, this document would be beneficial in justifying their selection; however, the impact on generic sponsors of ANDAs is not very clear.
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The document is now entering Step 5 — the implementation period. The scope of the document follows that of ICH Q It is also emphasised that designation of starting materials should be based on process knowledge for the intended commercial process.
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