FDA finalises ICH Q&A guideline on the development and manufacture of drug substances

The US Food and Drug Administration (FDA) has finalised the International Council for Harmonisation’s (ICH) question and answer (Q&A) guideline on the development and manufacture of drug substances.

The guidance contains questions and answers that were developed in February 2017, to clarify the principles for selecting starting materials described in the ICH guidance “Q11 Development and Manufacture of Drug Substances”, published November 20, 2012.

The Q&A document is expected to provide further clarification, promote convergence and improve harmonisation of the considerations for the selection and justification of starting materials. Furthermore the guidance focuses on chemical entity drug substances and includes information that should be provided for marketing authorisation applications and/or Master Files.

The guideline has not been amended since the version endorsed by the ICH in August 2017. Answers to 16 questions are provided 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.

To read the finalised Q&A guidance entitled “Q11 Development and Manufacture of Drug Substances– Questions and Answers (Chemical Entities and Biotechnological/Biological Entities)”, please click here.