Description
This course will provide a basic understanding of the FDA Scaleup
and Post Approval Changes Guidelines & the recent 2004 guideline
on Changes to approved NDA or ANDA. This also addresses the
impact of withdrawal of the FDA BACPAC I guideline on changes in
API synthesis. The issues affecting batch size scaleup/ scale-down,
various post approval formulation component or composition changes,
site of manufacturing changes, manufacturing process changes,
and/or equipment changes will be addressed along with the issues
affecting analytical methodology, packaging and labeling changes.
The course will focus on:<ol><li>
The criteria that determines the level or degree of change.</li>
<li>The type of study data or information that must be generated
to support changes at each level.</li>
<li>The FDA recommended chemistry manufacturing & control
tests to support each level or degree of change.</li>
<li>The type of in-vivo or in-vitro testing required to support the
various levels of degrees of change.</li></ol>
Case examples will be employed to allow the students to
determine the type of data that are required to support the level
of changes proposed.
