Wednesday, January 25, 2023 - 11:00am to 1:00pm EST
This presentation focuses on:
How
to audit excipient manufacturers and their subcontractors for good
manufacturing practices as defined in the NSF/IPEC/ANSI 363 Excipient
GMP Standard using IPEC-Americas 2023 audit guide.
Learning/Awareness Objectives
Attendees will be able to:
> Understand how the audit guide is organized
> Learn how to use the guide to ensure a thorough audit
> Determine whether to use the checklist of questions or reminder phrases
> Use the guide as a reference to determine the requirements of the ANSI 363 standard
Who should attend?
> Excipient manufacturers, users, distributors
> Regulatory affairs
> Compendial affairs
> Quality affairs