|
|
Article: Benefits debated for pre-approval, or post-approval; can PAT help 90% of oral solids? (Process analytical technology).
- Article from:
- Validation Times
- Article date:
- June 1, 2002
- Author:
CopyrightCOPYRIGHT 2002 Washington Information Source, Inc. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan. All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)
|
GAITHERSBURG, MD -- About 90% of solid oral dosage form drugs are made the old-fashioned way, largely through wet granulation processes, according to pharmaceutical industry experts. So, how can process analytical technology (PAT), which FDA and some in the industry see as the wave of the future, replace the need for traditional validation of all the steps one needs to take to make a capsule or tablet?
That's the issue that arose at a June 12 meeting of the agency's PAT Subcommittee of its Advisory Committee on Pharmaceutical Science, which is trying to draft guidance for industry on using PAT by year end.
Under PAT, drug manufacturers would move from ...