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). 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 concepts described in ICH Guidelines on Pharmaceutical Development (Q8), Quality Risk Management (Q9) and Pharmaceutical Quality System (Q10) as they pertain to the development and manufacture of drug substance. A company can choose to follow different approaches in developing a drug substance. For the purpose of this guideline, the terms “traditional” and “enhanced” are used to differentiate two possible approaches. In a traditional approach, set points and operating ranges for process parameters are defined and the drug substance control strategy is typically based on demonstration of process reproducibility and testing to meet established acceptance criteria. In an enhanced approach, risk management and scientific knowledge are used more extensively to identify and understand process parameters and unit operations that impact critical quality attributes (CQAs) and develop appropriate control strategies applicable over the lifecycle of the drug substance
which may include the establishment of design space(s). As 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 regulatory flexibility is generally predicated on the level of relevant scientific knowledge
provided in the application for marketing authorisation. Traditional and enhanced approaches are not mutually exclusive. A company can use
either a traditional approach or an enhanced approach to drug substance development, or a combination of both.
2. Scope
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. It is particularly relevant to the preparation and organisation of the contents of Sections 3.2.S.2.2 –3.2.S.2.6 of Module 3 of the Common Technical Document (ICH M4Q). The guideline does not apply to contents of submissions during the clinical research stages of drug development. Nevertheless, the development principles presented in this guideline are important to consider during the investigational stages. Regional requirements for post-approval changes are not covered by this guideline.
Want to know more: https://database.ich.org/sites/default/files/Q11%20Guideline.pdf
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