Module 9 2024

03/09/2024

Specific Module 3 Components (cont.)

3.2.A Appendices

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• Largely consistent structure across major ICH regions as well defined in ICH M4Q • 3.2.A.1 Facilities and Equipment • 3.2.A.2 Adventitious Agents Safety Evaluation • 3.2.A.3 Excipients • Differences in focus (i.e. biologics inherently present a higher adventitious agents risk)

• Differences in maintenance between regions (3.2.A.1 in particular)

The Organisation for Professionals in Regulatory Affairs

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Specific Module 3 Components (cont.)

Module 3.2.R

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• Content defined by region in ICH M4Q for US and EU (see screenshot below) (NB - ICH M4Q (R1) pre-dates EU PACMPs = Comparability Protocols)

The Organisation for Professionals in Regulatory Affairs

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