Chemical-Pharmaceutical Documentation (CMC Module 3)

Do you work in regulatory affairs or in the quality department at a local affiliate of a pharmaceutical company and deal with chemical-pharmaceutical documentation (Module 3 CMC) focused on small molecules? Do you need an overview of the quality content in the CTD (Common Technical Document) structure and the key differences compared to biological medicines? If so, this 2-day course featuring lectures and case studies is perfect for you!
The course is held in Swedish.

Who should attend?

This course is for you who are working in local Regulatory Affairs or in the quality department at a pharmaceutical company’s affiliate. In your work, You prepare variation applications or work closely with CMC colleagues in EU or global functions, and you need to understand the overall picture and what is important to monitor in CMC documentation. It is also a valuable course if you are responsible for writing CMC documents, as it provides concrete tips on what should be included. The course focuses on the content and details of the various CMC modules and it offers valuable guidance on what to consider when writing or reviewing CMC documents.

Learnig objectives

The training provides a solid understanding of the quality content in CTD Module 3, Module 2.3 Quality Overall Summary (QOS), and related information in Module 1. After completing the course, you will have an improved understanding of how chemical-pharmaceutical documentation is structured and you will be able to evaluate its content to meet regulatory requirements based on the company’s manufacturing process.

The course will give you:

• Knowledge of the quality content (Module 3 CMC) within the CTD structure

• Skills to write and review the quality content within the CTD structure

• Competence to interpret and assess guidelines and regulations relevant to the area

Course outline

Introduction to chemical-pharmaceutical documentation

• Pharmacopeias
• Preparation of Module 3 for MAA/MAV
• Substance
• 3.2.S.1 General Information
• 3.2.S.2 Manufacture
• 3.2.S.3 Characterisation
• 3.2.S.4 Control of Drug Substance
• 3.2.S.5 Reference Standards or Materials
• 3.2.S.6 Container Closure System
• 3.2.S.7 Stability
• ASMF och CEP
• Product
• 3.2.P.1 Description and Composition of the Drug Product
• 3.2.P.2 Pharmaceutical Development
• 3.2.P.3 Manufacture
• 3.2.P.4 Control of Excipients
• 3.2.P.5 Control of Drug Product
• 3.2.P.6 Reference Standards or Materials
• 3.2.P.7 Container Closure System
• 3.2.P.8 Stability
• Quality Overall Summary
• Module 1 – What is reflected from module 3