Module 9 2021

16/03/2021

General Structure of Module 3 (cont.) • Module 3 is essentially broken down into key areas 1. Description of the substance/product 2. Manufacturing Process

3. Characterisation of the substance/product 4. Controls to test the final substance/product 5. Reference material/standards 6. Container closure 7. Stability • Essentially the same for drug substance (3.2.S) and drug product (3.2.P) • Small molecules: option to refer to a Drug Master File/Active Substance Master File in place of or supporting 3.2.S (EU) – DMFs can be a viable option for other elements in other countries (e.g. US, China etc)

The Organisation for Professionals in Regulatory Affairs

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Specific Module 3 Components

• Will not go through all Module 3 components • Focus on key Module 3 sections for Active Substances & Products ● Placebos, NIMPs, comparators are similar but different • Much of the basic content is defined for commercial products in ICH M4Q and for clinical products through regional guidance • Medical Devices continues to be a hot topic which is developing alongside implementation of the EU Medical Device regulation

The Organisation for Professionals in Regulatory Affairs

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