Industries: Pharma / Biotech

Preparing the CMC Section for NDAs/INDs/CTDs

Course Director: Priya Jambhekar


Course Fee: $2150.00 Regular Registration / $1950.00 Early Bird (30 Days in Advance)

  Accreditation: ***RAPS Approved Course***

Course Description

This course includes an overview of the International Conference on Harmonization (ICH) process and the organization of the CTD, detailed information and discussions related to each element required in the drug substance and drug product sections of NDAs and INDs. The course emphasizes the requirements related to drug substance starting materials, drug substance and drug product specifications, impurities, stability, and pharmaceutical development reports. It also Addresses the use of Drug Master Files (DMF) and preparation of the CTD Quality Overall Summary (Module 2).

In addition to describing the requirements for the CMC section of NDA’s and IND’s as stipulated in ICH and FDA guidances, this course discusses the new Draft Q12 ICH guidance.  The course presents many examples and strategies for complying with the requirements and provides ample opportunity for questions and discussion.

Who Should Attend

This course is designed for personnel involved in preparing the chemistry, manufacturing and controls (CMC) section of a NDA or IND and for personnel who are not involved in CMC document preparation but want an overall understanding of what is involved for both the drug substance and drug product.

Please note: This course covers the requirements for synthetic, small molecules and does not address biologics.  Biologics are addressed in our course "CMC Regulatory Compliance for Biopharmaceuticals, Biosimilars and Other Biologics"

Course Agenda


9:00 – 10:00 ICH Process and CTD Organization

  • Minimum and optimum granularity
  • Impact of Established Conditions on preparation of new NDA
  • Differences between Draft ICH Q12 Pharmaceutical Product Lifecycle Management and existing FDA guidances

10:00 – 5:00 Requirements for the Drug Substance (Module 3 of CTD)

  • S.1 General Information:
    • Nomenclature, structure, general properties
  • S.2 Manufacture
    • Use of contractors vs in-house manufacturers
    • Detail necessary in manufacturing process description
    • Determination of critical steps and controls
    • Reprocessing vs rework
    • Use of alternative processes
    • Justification for starting materials
    • When to validate manufacturing process
    • Manufacturing process development (Q11)
    • Development of Control Strategy
  • S.3 Characterization
    • Potential for polymorphs
    • Specified/unspecified impurities vs identified/unidentified impurities
    • Impurity thresholds
    • Genotoxic impurities
  • S.4 Control of the Drug Substance
    • Universal vs specific tests in specifications
    • Requirements for alternative analytical procedures
    • Transfer of analytical procedures
    • When to validate analytical procedures
    • Importance of batch analyses table
    • How to justify specifications
  • S.5 Reference Standards
    • Use of primary vs secondary reference standards
  • S.6 Container Closure System
    • Suitability of container closure system
  • S.7 Stability
    • Requirements for primary registration stability studies
    • Rationale for forced degradation/stress testing
    • Extension of retest dating period
    • Requirements for post-approval stability studies


9:00 – 10:00 Drug Master Files (DMFs)

  • What is a DMF
  • Types of DMFs
  • Why are DMFs used
  • How are DMFs used
  • Role play DMF process
  • What goes into DMF vs NDA

10:00 – 2:30 Requirements for the Drug Product (Module 3 of CTD)

  • P.1 Description and Composition
    • Naming of salts
  • P.2 Pharmaceutical Development
    • Drug substance information needed for pharmaceutical development
    • Impact of excipient choice and concentration
    • Rationale for overage vs overfill
    • Elements of container closure suitability
    • Container closure development vs container closure information in P.6
    • Rationale for preservative systems
  • P.3 Manufacture
    • Use of contractors vs in-house manufacturers
    • Detail necessary in manufacturing process description
    • When to validate manufacturing processes
  • P.4 Control of Excipients
    • Information required for excipients
    • Justification for excipient specifications
    • Requirements for novel excipients
  • P.5 Control of the Drug Product
    • Universal vs specific tests in specifications
    • Drug product vs drug substance impurities in specifications
    • Justification for specifications
  • P.6 Reference Standards
    • Need for impurity reference standards
  • P.7 Container Closure Systems
    • Requirements for primary vs secondary vs functional secondary container closures
  • P.8 Stability
    • Requirements for primary registration stability studies
    • When to bracket or matrix stability studies
    • Need for forced degradation/stress testing
    • Need for in-use studies
    • Need for cycling studies
    • Extension of expiration dating period
    • Requirements for post-approval stability studies

2:30 – 3:00 CMC Appendices/Regional Information

  • Executed batch records to be provided
  • FDA analytical method validation
  • Comparability protocol content and benefit

3:00 – 3:30 Quality Overall Summary (Module 2 of CTD)

  • When and how to prepare Module 2

3:30 – 4:00 FDA Interactions

  • How to prepare for FDA meetings
  • CMC-specific meeting or general meeting
  • How to respond to FDA questions

Learning Objectives

This course will provide participants with a thorough understanding of the requirements for each CMC/Quality section of the Common Technical Document (CTD), the format to be used for NDAs, including preparation of the Quality Overall Summary (Module 2). It will also present techniques for making the CMC submission easy to review, including sample tables and figures, and discuss how to address issues during meetings with FDA and NDA review.


"Instructor went through the content very well and kept things moving. She adapted well to participants questions." Susan T., Sr. Medical Writer, MMS Holdings
"One of the best courses I've taken, I learned a great deal." Jiang L., Principal Investigator, Enanta Pharmaceuticals
"This was the first course I have taken with CfPIE and it was very interactive and informative. It was a great experience and starting point for me." Harpreet K., Senior Chem Mgr, Dalton Pharma Services
"The course was very well designed and covered the material nicely." Jesper V., Scientist, Zealand Pharma
"The course director is a very good communicator and exceptional instructor. She was very patient in explaining the various modules and coordinating the discussions. I learned much more with this course and can say that my knowledge regarding the CMC preparation has improved significantly after attending this course. I will be on the lookout for other courses offered by CfPIE" Sheetal M., Principal Scientist, Purdue Pharma L.P.
"The course director was an excellent presenter. I am a project manager and took this course as a way to get an overview of the CMC. I learned so much! This will be very useful as reference as I lead my project teams in Drug Development. She did an excellent job managing and answering questions from SMES from all areas - Analytical Regulatory, Formulation, DP Development, DS Development, Quality." Karen B., Sr. Project Manager, Pfizer
"An excellent seminar for everyone coordinating, writing or reviewing the CMC sections of drug substance and drug product NDAs/INDs for small molecules." A. Agidotan, Manager, PharmaLex GmbH
"This was an excellent instructor with great real-world experiences who presented the information very clearly!" David D., Scientist, Upsher Smith Laboratories
"This course was a great class for me! Previously, I had only been involved with the early R&D activities and never have written any submission sections. This course helped me clarify the relationships between ICH guidelines and NDA submissions, as well as delineate between the different types of ICH guidelines." David A., Global Program Manager, Synthes
"I thought this course was excellent and very relevant to my work. It will benefit me greatly as I move closer to preparing for NDA filing. The instructor encouraged questions and discussions which provided different perspectives and other companies' experiences/practices. This was very beneficial as well." Elizabeth G., Research Scientist, BMS
"The course director was very knowledgeable in presenting her material. She was able to provide real life examples to support her discussion. The course notes will be a valuable reference tool for future use." Sylvie A., Project Leader, Regulatory Affairs, Sanofi-Aventis Canada
"I am involved in Research and Process Development of API. By attending this excellent course I really could see what my role was in the overall regulatory filings process and how important it was from the quality perspective." Hitesh B., Manager, R&D, United Therapeutic

Frequently Asked Questions

How much of the course deals with NDAs and how much with INDs?

The course discusses all the ICH requirements for the CMC section of NDAs, i.e., Module 3 and the Quality Section of Module 2. This provides participants who are working on NDAs with a detailed outline from which to construct an NDA. For participants who are working on INDs, the course provides the scope of studies that will be needed to prepare an NDA and a discussion of the reduced requirements for each Module 3 section for INDs in Phase 1, 2 and 3.

Does the course cover biologics and ANDAs?

The course does not cover the information and data required for filing a biologically produced active ingredient to be filed with CBER nor specific requirements for ANDAs.

Does the course cover post-approval changes?

The course addresses submission of Comparability Protocols for post-approval changes but not other guidances related to post-approval changes.

I am new to CMC and regulatory affairs. Will I understand what is being presented?

The course covers the requirements for NDAs and INDs in a very systematic way and provides a complete overview so it is a good introduction to this field.

I have filed several NDAs already. Will I get anything out of the class?

Participants with experience filing NDAs have found the course valuable in assessing whether they are filing too much or too little information and data.


Preparing the CMC Section for NDAs/INDs/CTDs: Meet the Instructor

Meet Maria Geigel, CfPIE’s Course Director for “Preparing the CMC Section for NDAs/INDs/CTDs”. Maria gives a snapshot of the 2-day classroom course which focuses on the requirements related to drug substance starting materials, drug substance and drug product specifications, impurities, stability, and pharmaceutical development reports.

RAPS | Regulatory Affairs Professionals Society CfPIE is a Regulatory Affairs Professional Society (RAPS) RA Professional Development provider.

CfPIE is committed to enhancing the ongoing professional development of regulatory affairs professionals and others through appropriate regulatory affairs learning activities and programs.  CfPIE has agreed to follow RAPS-established operational and educational criteria.  Click here for the list of courses reviewed and approved by RAPS.