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Q11 – Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological/Biological Entities)
Guideline number: Q11
Status: Implementation (Step 5)
Adopted (Step 4): 1 May 2012
The Guideline reached Step 4 of the ICH process on 1 May 2012.
This Guideline describes approaches to developing and understanding the manufacturing process of the drug substance, and also provides guidance on what information should be provided in Module 3 of the Common Technical Document (CTD) Sections 3.2.S.2.2 – 3.2.S.2.6 (ICH M4Q). It addresses aspects of development and manufacture that pertain to drug substance, including the presence of steps designed to reduce impurities.
This Guideline is applicable to drug substances as defined in the Scope sections of ICH Guidelines Q6A and Q6B but might also be appropriate for other types of products following consultation with the appropriate regulatory authorities.
The ICH Harmonised Guideline was finalised under Step 4 in July 1997. This document covers the preclinical safety testing requirements for biotechnological products. It addresses the use of animal models of disease, determination of when genotoxicity assays and carcinogenicity studies should be performed, and the impact of antibody formation on duration of toxicology studies.
An addendum was proposed to provide clarification on S6 and an update of the following topics discussed in the original ICH S6 Guideline: species selection, study design, immunogenicity, reproductive and developmental toxicity and assessment of carcinogenic potential. The Harmonised addendum provides further complementary guidance to the S6 Guideline and helps to define the current recommendations and reduce the likelihood that substantial differences will exist among regions.
The addendum reached Step 4 of the harmonisation process in June 2011 and was integrated as part II in the core Guideline that was then renamed S6(R1).
Q+A
Q+A number: Q11 Q&As
Q+A Status: Implementation (Step 5)
Q+A Adopted (Step X): 23 August 2017
Q+A implementation
Since reaching Step 4 in 2012, worldwide experience with implementation of the ICH Q11 Guideline and its recommendations on the development and manufacture of drug substances has given rise to requests for clarification relating to the selection and justification of starting materials.
The Q11 Implementation Working Group (IWG), established by ICH in 2014, developed a Questions and Answers (Q&A) document which reached Step 4 of the ICH Process in August 2017.
These Q&As are intended to provide additional clarification, and to promote convergence and improve harmonisation of the considerations for the selection and justification of starting materials 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. Training materials and a training video on Q11 Q&As are also available.
