Module 9 2024

03/09/2024

Specific Module 3 Components (cont.)

• 3.2.S.2.2 Manufacturing Process

• Key compliance section

• Describe the manufacturing process (including potential re-processing) with a clear flow diagram

• Typically include limits for critical steps and parameters only

• SM – start with the starting material but typically a simple chemical scheme

• Biotech – start with a vial of the cell bank and a much more detailed description is required as likely to include multiple purification and modification reactions

The Organisation for Professionals in Regulatory Affairs

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Specific Module 3 Components (cont.)

• 3.2.S.2.3 Control of Materials

• SM – typically straightforward description of the quality of raw materials, solvents, reagents & catalysts

• Biotech – considerably more complex descriptions including control of source and starting materials of biological origin, source history and generation of the cell substrate, cell banking system characterisation and testing

The Organisation for Professionals in Regulatory Affairs

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