The International Council for Harmonisation (ICH) has released a Question & Answers document on its ICH Q11 guideline, Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological/Biological Entities).
This document includes 16 questions and answers in relation with the selection of starting materials and source materials, gathered from experience and requests received since the publication of the guideline in 2012. It provides clarification on the considerations for the selection and justification of starting materials and on the information that should be provided in marketing authorisation applications.
A 2-parts decision tree has also been created to help manufacturers determine:
- Whether a starting material needs to be redefine or if it is suitable to be proposed in an application;
- Which manufacturing step have an impact on drug substance impurity profile.
ICH also advises manufactures that drug substances in authorised products would not need to be re-justified against the ICH Q11 principles, unless significant changes are made to the manufacturing processes and controls. In addition, they remind companies that a starting material accepted for one manufacturer’s process may not be acceptable for a different manufacturer’s process if the proposal does not comply with ICH Q11 principles.