Q11 Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological / Biological Entities)
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.
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Date of Step 4: 1 May 2012
Status: Step 5
Guidelines (Click the links below for complete guidelines)
Endorsed Documents (Click the links below for complete guidelines)
WG Presentations / Trainings (Click the links below for complete guidelines)
Q11 Q&As Questions & Answers: Selection and Justification of Starting Materials for the Manufacture of Drug Substances
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.
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Date of Step 4: 23 August 2017
Status: Step 5
Questions & Answers (Click the links below for complete guidelines)
Endorsed Documents (Click the links below for complete guidelines)
WG Presentations / Trainings (Click the links below for complete guidelines)
*These Guidelines Belongs to ICH website.
