Understanding pharmaceutical quality by design
Contributor(s):: Yu, Lawrence X, Amidon, Gregory Khan, Mansoor A Hoag, Stephen W, Polli, James, Raju, G K, Woodcock, Janet
This review further clarifies the concept of pharmaceutical quality by design (QbD) and describes its objectives. QbD elements include the following: (1) a quality target product profile (QTPP) that identifies the critical quality attributes (CQAs) of the drug product; (2) product design and...
A Review of Process Analytical Technology (PAT) in the U.S. Pharmaceutical Industry
Contributor(s):: Munson, James, Stanfield, C. Freeman, Gujral, Bir
Process Analytical Technologies (PAT) are used to provide timely analysis of critical quality parameters with the end goal of improving final product quality as well as reducing manufacturing costs, thereby significantly benefiting the Pharmaceutical Industry. PAT involves mostly on-line or...