(Note: This post is part of a multi-part series on the CTD this fall)

Module 3 of the CTD contains the Quality data, which is the detailed information on the chemistry, manufacturing process, and control strategy for both the drug substance (the active material, whether chemical or biologic) and the drug product (the final dosage form(s)). The requirements for this section are in ICH M4Q and the related regional implementation guidance (the FDA directly references the ICH M4Q for the content in Module 3). The subsections are very similar between drug substance and drug product, with a few key differences:

Drug Substance Section

1. General information
2. Manufacture
3. Characterization
4. Control of drug substance
5. Reference standards or materials
6. Container closure system, and
7. Stability

Drug Product Section

1. Description and composition of the drug product
2. Pharmaceutical development
3. Manufacture
4. Control of excipients
5. Control of drug product
6. Reference standards or materials
7. Container closure system
8. Stability

The section ends with appendices that list facilities and equipment for each manufacturer, a safety evaluation of any adventitious agents, and excipients. The ICH working group has also prepared a Q&A document to answer questions about the location of specific items within this section. Some common situations addressed in this document include multiple manufacturing facilities or multiple containers for drug substance or drug product. The FDA version of this Q&A document contains the same content as the ICH document.

Reach out to me if you want to know more or discuss your medical product development challenges.

katrina@krogersconsulting.com

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Text Copyright © 2019 Katrina Rogers

Follow the links below to read each part of the series.

Electronic Regulatory Submissions Part 1

Electronic Regulatory Submissions Part 2

Electronic Regulatory Submissions Part 3

Electronic Regulatory Submissions Part 4

Electronic Regulatory Submissions Part 5

Electronic Regulatory Submissions Part 6

Electronic Regulatory Submissions Part 7

Electronic Regulatory Submissions Part 8

Electronic Regulatory Submissions Part 10

Electronic Regulatory Submissions Part 11

Electronic Regulatory Submissions Part 12

Electronic Regulatory Submissions Part 13

Electronic Regulatory Submissions Part 14

Electronic Regulatory Submissions Part 15

Electronic Regulatory Submissions Part 16