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FDA Finalizes ICH Q&A Guideline on Drug Substance Manufacturing

Posted 23 February 2018 | By Michael Mezher 

FDA Finalizes ICH Q&A Guideline on Drug Substance Manufacturing

The US Food and Drug Administration (FDA) on Friday finalized its version of the International Council for Harmonisation's (ICH) questions and answers companion to ICH's guideline on the development and manufacture of drug substances.

FDA consulted on the draft version of the questions and answers document in February 2017 and following the consultation, and similar consultations by other ICH regulatory members, the ICH Assembly endorsed the document in August 2017.

Specifically, the questions and answers guideline is meant to expand on ICH's 2012 guideline on drug substance manufacturing, Q11 Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological/Biological Entities).

According to FDA, the questions and answers document provides "additional clarification and to promote convergence on the considerations for the selection and justification of starting materials" for drug manufacture, with a focus on the synthesis of chemical drugs.

The guideline, which is the same as the version endorsed by ICH in August, includes answers to 16 questions on justifying and selecting starting materials, as well as two decision trees focused on the evaluation of a proposed starting material and determining which steps in manufacturing have an impact on the drug substance's impurity profile.

FDA, Federal Register Notice


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