Quality Systems

Sep 02, 2013
Pharmaceutical Technology
By Pharmaceutical Technology Editors
The adoption of quality by design in small-molecule drug development and manufacturing continues to evolve as the industry seeks ways to augment process understanding for APIs
Aug 01, 2013
Pharmaceutical Technology
By Pharmaceutical Technology Editors
Recent draft guidance from FDA on contract manufacturing and quality agreements highlights the importance of such agreements and define the roles and responsibilities of each party to be in keeping with quality risk-management principles.
Jul 02, 2013
Pharmaceutical Technology
Greater sophistication in 3D X-ray imaging technology raises its utility for QA/QC in manufacturing.
Jul 02, 2013
Pharmaceutical Technology
Increased manufacturer outsourcing requires clear policies and written agreements with CMOs.
May 02, 2013
Pharmaceutical Technology
By Pharmaceutical Technology Editors
Compositing samples is appropriate under certain circumstances but raises caveats on how and when it should be applied.
Apr 02, 2013
Pharmaceutical Technology
By Pharmaceutical Technology Editors
The mysteries of rounding are exposed; strict, unbiased rounding can be applied.
Mar 29, 2013
Pharmaceutical Technology
By Pharmaceutical Technology Editors
Keith Bader, senior director of technology at Hyde Engineering + Consulting discusses his presentation ?Establishing a design space: cleaning process development and validation, which will be presented at Interphex 2013
Feb 02, 2013
Pharmaceutical Technology
By Pharmaceutical Technology Editors
Two methods to evaluate retest data following out-of-specification results.
Jan 01, 2013
Pharmaceutical Technology
Shortages and compounding disaster spur efforts to overhaul manufacturing oversight and stimulate industry improvements.
Dec 02, 2012
Pharmaceutical Technology
By Pharmaceutical Technology Editors
A change in terminology could emphasize patient protection.
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