According to the ICH (International Council for Harmonisation), the ICH Q11 Q&A reached Step 4 of the ICH process in August 2017. The document is now entering Step 5 – the implementation period.
Initiated already in 2014, the Question and Answer document on the development and manufacture of drug substances is intended to provide additional clarification for the selection of starting materials (section 5 in ICH Q11) and on the information that should be provided in marketing authorisation applications and/or Master Files. The focus of the Q&A document is on chemical entity drug substances. The scope of the document follows that of ICH Q 11.
As pointed out by the ICH “Applicant” is used throughout the Q&A document and should be interpreted broadly to refer to:
- the marketing authorization holder
- the filing applicant
- the drug product manufacturer, and/or
- the drug substance manufacturer.
It is also emphasised that designation of starting materials should be based on process knowledge for the intended commercial process. It is emphasized that all of the general principles in ICH Q11 Section 5 should always be considered holistically, together with the clarifications in this Q&A document, rather than applying a single general principle or Q&A clarification in isolation.
The 16 Q&As are complemented by a decision tree in Annex 1 to serve as a pictorial exemplification to apply to all ICH Q11 general principles for the selection and justification of a starting material.