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The agency clarifies recommendations found in ICH Q11 about chemical entities and biotechnology entities.
On Feb. 28, 2018, FDA published guidance answering questions regarding International Council for Harmonization (ICH) Q11 Development and Manufacture of Drug Substances, specifically chemical entities. The agency hopes this clarification will improve harmonization of the selection and justification of starting materials as well as the information provided in marketing authorization applications and master files.
Topics addressed in the document include principals found in section 5 of ICH Q11, clarification of “starting material” versus “API starting material”, and starting materials for linear and convergent syntheses. FDA clarifies the selection of starting materials in processes where multiple chemical transformations are run without isolation of intermediates and explains the difference between commercially available chemicals and custom synthesized chemicals. Additional topics include mutagenic regents and impurities, post-approval changes, and more.