Module 12 Presentations

Option2

• Using multiple 3.2.P.4 sections without lower level granularity for 3.2.P.4.x • One or multiple files can be submitted at the 3.2.P.4 level (and not at a 3.2.P.4.x level) per excipient or grouping of excipients, covering relevant excipient topics. • The “ excipient ” attribute is used to identify the excipient name or group name (e.g., “ compendial ”)

The Organisationfor Professionals in Regulatory Affairs