In this webinar, you will learn the required contents of Module 3 as well as the appropriate formatting. Lifecycle management and updating requirements will be discussed, including appropriate change control and sponsor notifications. You will also gain an understanding of contact points with the FDA throughout the lifecycle of the DMF, including information requests and inspections.
Type 2 DMFs for Active Pharmaceutical Ingredients (APIs) are needed in order to protect confidential information and allow the ability for API manufacturers to sell to multiple customers, while providing and updating their information in only one submission and one format.
Information provided in the DMF must cover all required sections of the International Conference on Harmonization (ICH) CTD guidance document covering the Module 3 drug substance section. This section requires details about the development of the API, raw materials, equipment, formulation, critical attributes, manufacturing process and controls, analytical methods, specifications and stability.
- Manufacturing process development
- Process controls
- Selection of starting materials
- Control strategy
- Process validation evaluation
- Submission of information into the DMF, content & format
- Providing letters of reference to support a sponsor CTD
- Life cycle management of the DMF
- Interactions with the FDA throughout the DMF lifecycle
This presentation is targeted toward the following organizational positions and disciplines and is presented in practical language understandable by all technically educated or trained individuals, regardless of specialty. This information would be useful at levels from senior management to operative, and would be valuable for experience levels ranging from seasoned veterans to those newly assigned to roles related to manufacturing:
- Regulatory Affairs
- Quality Assurance
- Project Management
- Regulatory Operations
- Process Automation Manufacturing Operations
- Process and Design Engineering
- Quality Control (Chem and Micro)
- Utility Operations
- Anyone responsible for providing content for the CTD