ICH Q11 STEP 4 PDF

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. Many criteria for selecting the proper starting material may not be subject to the open part of the DMF and, thus, may not be clear to the drug product manufacturer when they select their API source. The redefinition of regulatory starting material is one of the roadblocks to the first cycle approval of ANDAs; thus, the ANDA holders should do their due diligence to make sure that this issue does not stand in the way of approval.

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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. ICH: News release. Our website uses cookies. This includes cookies that are technically necessary for the proper operation of the site, as well as cookies that are used for statistical purposes, for comfort settings or to display personalized content.

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