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This document describes approaches to developing and understanding the manufacturing process of the drug substance. It also provides guidance on what information should be provided in sections 3.2.S.2.2 – 3.2.S.2.6 ( ICH M4Q).
- ICH guideline Q11 on development and manufacture of drug substances ...
discussed in ICH Q8 for drug product, a greater...
- Q11 Step 5 Development and manufacture of drug substances
Common Technical Document (CTD) sections 3.2.S.2.2 –...
- ICH guideline Q11 on development and manufacture of drug substances ...
discussed in ICH Q8 for drug product, a greater understanding of the drug substance and its manufacturing process can create the basis for more flexible regulatory approaches. The degree of
Q11 1. Introduction 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).
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This guideline provides approaches and principles for developing and understanding the manufacturing process of the drug substance, and what information to submit in the CTD. It covers topics such as process development, starting materials, control strategy, process validation and lifecycle management.
Quality Guidelines. Harmonisation achievements in the Quality area include pivotal milestones such as the conduct of stability studies, defining relevant thresholds for impurities testing and a more flexible approach to pharmaceutical quality based on Good Manufacturing Practice (GMP) risk management.
This FDA guidance explains how to develop and understand the manufacturing process of the drug substance, and what information to provide in the CTD. It also clarifies the ICH principles and concepts related to drug substance quality.
• Clarifying how to apply the ICH Q11 general principles – selection of appropriate starting materials based on science and knowledge of the proposed commercial manufacturing process and controls.
