Preparing for Regulatory Filings: Specific Information Needed for the Chemistry, Manufacturing, and Controls (CMC) Section and CMC Q&A

Event description

Presenter: Dr. Carmella Moody

Join our webinar, Preparing for Regulatory Filings: Specific Information Needed for the Chemistry, Manufacturing, and Controls (CMC) Section, where Dr. Carmella Moody will guide you through the essential data and documentation required for successful regulatory submissions. This session will cover key CMC elements, including drug substance and product characterization, manufacturing processes, analytical methods, and stability data. Don't miss this opportunity to streamline your filing process and enhance your submission strategy.

Dr. Carmella Moody brings her expertise in regulatory affairs and the development of small molecules to the Catalyze program, where she serves as a technical project lead. This webinar is meant to be discussion-based, and Dr. Moody encourages you to bring your questions related to CMC regulatory filings.

This presentation is developed for applicants intending to apply or re-apply to Catalyze Product Definition or Preclinical Services Programs.

Webinar presented on April 15, 2025 to an invited audience.

This video is provided for educational purposes only.

Download slides

Chapters

0:00
Welcome
2:18
CATALYZE Resource for Questions
2:59
Critical References for CMC, Module 3 (Quality) for INDs
5:23
Electronic Common Document (eCTD) Modules
6:37
Overview of Presentation
8:10
Drug Substance CMC (Quality) Information in Module 3 CTD Format
8:16
Module 3 CTD Drug Substance Sections
9:05
3.2.S.1.2 Structure
10:00
3.2.S.1.3 General Properties
10:50
3.2.S.2.2 Description of Manufacturing Process and Process Controls
13:17
3.2.S.2.3 Control of Materials
14:35
3.2.S.3.2 Impurities
16:26
3.2.S.4.1 Specification
18:03
3.2.S.4.1 Specification (Example Small Molecule)
18:42
3.2.S.4.2 Analytical Procedures
19:53
3.2.S.4.4 Batch Analysis
22:27
3.2.S.4.5 Justification of Specification
23:20
3.2.S.5 Reference Standards or Materials
24:41
3.2.S.6 Container - Closure System
25:31
3.2.S.7.1 Stability Summary and Conclusions
26:34
3.2.S.7.3 Stability Data
27:11
Drug Product CMC (Quality) Information in Module 3 CTD Format
27:17
3.2.P Drug product [name, dosage form, manufacturer]
27:39
3.2.P.1 Description and Composition of the Drug Product
28:14
3.2.P.3.2 Batch Formula
28:36
3.2.P.3.3 Description of Manufacturing Process and Process Controls
29:21
3.2.P.4.1 Specifications
30:56
3.2.P.4.5 Excipients of Human or Animal Origin
32:14
3.2.P.4.6 Novel Excipients
33:19
3.2.P.5.1 Specifications
34:46
3.2.P.5.1 Specification(s) - Example
36:29
3.2.P.5.2 Analytical Procedures
36:54
3.2.P.7 Container-Closure System
37:58
3.2.P.8.1 Stability Summary and Conclusion
40:23
3.2.P.8.3 Stability Data
41:52
1.12.14 Environmental Analysis
42:46
1.14.4.2 Investigational Drug Labeling
45:06
QUESTIONS Provided Before Presentation
45:11
Questions - PreIND
46:43
Questions - IND
49:17
Q&A
This research was, in part, funded by the National Institutes of Health (NIH) Agreement OT2 HL157844-01. The views and conclusions contained in this document are those of the authors and should not be interpreted as representing the official policies, either expressed or implied, of the NIH.