Links and Files
Authors
- Joanne S. Eglovitch (RAPS)
Abstract
The US pharmaceutical industry has told the US Food and Drug Administration (FDA) that using process models alone is sufficient for assessing batch uniformity in advanced manufacturing. They believe that it is not necessary to combine this approach with in-process material testing to demonstrate uniformity.
Journal
Reg
Type of publication
Website
Affiliations
- RAPS
Classification Areas
- Regulatory