Module 9 2024

03/09/2024

Specific Module 3 Components (cont.)

• 3.2.S.2.5 Process Validation

• SM – typically not applicable

• Biotech – considerably more complex section which evolves as a program develops. Essentially you need to provide sufficient information to demonstrate appropriate validation and evaluation of the manufacturing process for the stage of development of your product

The Organisation for Professionals in Regulatory Affairs

15

Specific Module 3 Components (cont.)

• 3.2.S.2.6 Manufacturing Process Development

• Critical section for justifying applicability of your current/future manufacturing process to what was used in previous clinical studies

• SM – typically not extensive but this is changing

• Biotech – considerably more complex section which needs to clearly assess the impact of each manufacturing change through product development on the drug substance and drug product which can include specific nonclinical or in some cases clinical studies

The Organisation for Professionals in Regulatory Affairs

16

8