Module 9 2021

16/03/2021

Specific Module 3 Components (cont.)

3.2.A Appendices ● 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 ● 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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