The primary goal
of the IPEC Certificate of Analysis Guide for Pharmaceutical Excipients
guide is to provide best practices for the preparation and appropriate
use of a Certificate of Analysis (COA) for pharmaceutical excipients.
The
webinar will also review the IPEC Stability Guide for Pharmaceutical
Excipients. The primary goal of the Stability Guide is to offer best
practices and guidance in the establishment of an excipient stability
program; and is intended to provide excipient manufacturers with
strategies for assessment of overall stability. It also provides an
approach for a manufacturer to establish a stability study program which
may be used to support regulatory filings, aid in maintaining the
quality of the excipient, and define substantiate recommended storage
conditions and shelf-life claims (e.g., re-evaluation date, expiration
date, and use-by by date).
Learning/Awareness Objectives
>
Overview of both the IPEC Certificate of Analysis Guide for
Pharmaceutical Excipients and the IPEC Stability Guide for
Pharmaceutical Excipients, including recent major changes
> Understanding of best practices for COA
>
Understanding of excipient stability, the stability program for
excipient and differences between excipient and API stability
> Define COA roles and responsibilities for the excipient manufacturer and distributor
>
Clarification of key points and terminology for both guides (e.g.,
retest date, identification testing, compendial compliance)
Who should attend?
Personnel
from excipient manufacturer, user and distributor regulatory, quality,
R&D, formulation, purchasing, manufacturing and supply chain areas
would benefit from attending this webinar.
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