Chemistry, Manufacturing and Controls (CMC)
Information regarding chemistry, manufacturing and controls (CMC) for drugs is an important and detailed section in a dossier to support clinical studies and marketing applications. This information must be updated as more information is gained throughout a drug’s lifecycle. The required content and format of the CMC section for various applications are described in guidance documents provided by the International Council on Harmonization (ICH) and individual regions where the product is intended to be marketed.
This course provides an overview of the CMC section of dossiers. It discusses the CMC information necessary to support original investigational applications; identifies CMC changes that require investigational application amendments; and provides an understanding of the CMC information needed to support marketing applications and postapproval submissions, including the use of Drug Master Files (DMFs) and CMC-specific guidances.
The CMC section is synonymous with the quality section in some application formats, such as the Common Technical Document (CTD). For ease of review, this discussion is generically described as the CMC section.
At a Glance
- Target Audience: This course is designed for regulatory, quality assurance and manufacturing personnel; individuals who are new to drug companies; and professionals assuming management of a CMC area
- Learning Level: Basic
- Total Length of Course: 5 Hours
- RAC Points: 5
- Pharmaceutical Certificate Elective
- Enrollment Period: 12 months
Learning Objectives
Upon completion of this course, participants should be able to:
- Identify the CMC information included in submissions to support clinical studies and marketing applications
- Discuss the role of ICH and individual regional guidances that should be referenced when preparing a CMC section
- Identify CMC changes that will require agency notification
- Explain different types of postapproval submissions
- Describe the use of Drug Master Files (DMFs)
Lesson Titles
- Lesson 1: General CMC Information
- Lesson 2: Clinical Trials
- Lesson 3: Marketing Applications
- Lesson 4: Postapproval CMC
- Lesson 5: CMC-Specific Guidance
This course is also included in:
