FDA Finalizes ICH Q&A Guideline on Drug Substance Manufacturing

The United States Food and Drug Administration (FDA) finalized on Friday its version of the Questions and Answers of the International Council on Harmonization (ICH) in addition to the ICH Guidelines for the Development and Manufacture of Substances of Drugs.

The FDA consulted the draft of the question and answer document in February 2017 and, after consultation and other similar consultations of other Members of the ICH Regulations, the ICP Assembly approved the document in August 2017.

Specifically, the Q & A Guide aims to develop the 2012 ICH guide on drug manufacturing, substance development and drug manufacturing (chemical entities and biotechnological / biological entities).

According to the FDA, the question and answer document provides "additional clarifications and favors the convergence on considerations for the selection and justification of the starting materials" for the manufacture of medicines, with a focus on the synthesis of chemical drugs.

The guide, which is the same as the version approved by ICH in August, includes answers to 16 questions on the justification and selection of starting materials, as well as two decision trees focused on the evaluation of a proposed starting substance. an impact on the profile of impurities of the drug substance.