OR WAIT null SECS
March 24, 2006
Implementing a PAT Strategy
March 02, 2006
Secondary sensors help protect feedback control systems from the effects of sensor drift.
February 01, 2006
If delaying the project has little consequence then you should probably not run the project in the first place.
Baselines are one of the most useful tools in the 'validation toolbox'. They can be used for a variety of tasks with great success. This article will examine how they can be used and for what.
January 01, 2006
Using the Bergum Method and the MS Excel software program, the author determines the probability of passing the USP dissolution test.
Contract manufactures are faced with multiple challenges when determining whether to implement process analytical technology into their clients' or their own infrastructure.
December 01, 2005
To produce an application or solution for a specific domain, a vendor must demonstrate a thorough understanding of the domain and its specific challenges.
A new Good Automated Manufacturing Practice (GAMP) guide on IT Infrastructure Control & Compliance was launched in Chicago (IL, USA) 23 August 2005.1 The guide is intended to support pharmaceutical companies in their effort to establish a well-defined and compliant infrastructure. This article discusses different aspects of the guide that may support your organization in getting — and keeping — your infrastructure under control.
November 09, 2005
The process analytical technology (PAT) initiative has been percolating at the US Food and Drug Administration for a long time, explained FDA's John E. Simmons at the AAPS Annual Meeting and Exposition on Wednesday. "If you think of PAT as an isolated set of applications, I think you are missing the point," Simmons said. "The FDA would like PAT to become commonplace?not to be an initiative, but common practice."
As a pharmaceutical formulation tool, molecular simulation is currently in its early infancy. Nonetheless, presenters at Wednesday?s AAPS Annual Meeting and Exposition demonstrated that the technology is beginning to attract some interest. The topic was discussed in a presentation titled "Application of Molecular Simulations to Formulation Development and Stability Prediction."
