Suchergebnisse
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).
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).
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. In addition, ICH Q11 provides further clarification on the principles and
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 guidance 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...
• 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.
