Can A Design Space Be Built On Material Attributes Alone?
- Type: Conference Presentation
You will be able to download and print a certificate for these PDH credits once the content has been viewed. If you have already viewed this content, please click here to login.
In April, 2009, the PhRMA Drug Product Technical Group sponsored an industry workshop to explore the practicality and limitations of defining a design space in terms of material attributes rather than process variables. This presentation summarizes and expands on the output of this workshop. A material-attribute design space would be independent of scale and configuration of process equipment and the associated process variables. For this reason, it would be portable in the sense that post-approval changes of equipment scale, nameplate, or location would not require regulatory approval. A hypothetical case study of an immediate release oral tablet is presented to illustrate how such a design space could be constructed and implemented.