The Challenge requires pre-reading of the following documents:

1.      ICH Q11 “Development and Manufacture of Drug Substances”

2.      D.H. Patel, J. K. Badjatya, and A. A. Patel, “PREPARATION AND REVIEW OF CHEMISTRY, MANUFACTURING AND CONTROL (CMC) SECTIONS OF CTD DOSSIER FOR MARKETING AUTHORIZATION”, Int J Drug Reg Affairs, vol. 5, no. 2, pp. 1-12, Jun. 2017.

3.      FDA’s Quality by Design for ANDAs: An Example for Immediate Release Dosage Forms


ICH Q11 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

The industry article (attached) summarizes the marketing application requirements (i.e. the critical aspects of marketing application in different CTD using countries).  A study conducted on regulatory queries by that frequently are asked of the applicant after submission (e.g. during approval process) and are presented by section of the CTD.


Read the instructions below closely and complete the challenge assignment as follows.


a.       Using the ICH Q11 requirements as a framework, describe what sections and associated content are needed to build a comprehensive Module 3 specifically for drug substance. 

b.      Where do you see gaps in the detail described in ICHQ11 versus the commonly cited queries during application review by the regulatory agencies?  Explain.

2.      Based on the case study (pre-read #3) which used previously for the modules on ICHQ8 (R2), explain how you would approach developing the respective drug substance sections for Generic Acetriptan Tablets, 20 mg. 

3.      Any references should be appropriately cited within your assignment. 

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