OR WAIT null SECS
April 01, 2008
Most CROs are entering China with expectations that a significant local market opportunity will develop as major pharmaceutical companies establish research development operations there...
Manufacturing facilities must be inspected by members of regulatory bodies. However… these bodies are woefully inadequate at performing the task.
March 02, 2008
If not properly monitored, filters and plastic bags can keep back more than they should.
February 02, 2008
If at first the product fails, then inspect, inspect again
January 02, 2008
Process efficiency is measured not only by what is kept, but also by what is thrown away.
January 01, 2008
The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) recently closed consultation on its draft guidance, ICH Q10 Pharmaceutical Quality System. If all goes to plan, adoption could come as soon as Spring 2008.
Historically, the main purpose of laboratory information management systems (LIMS) has been to track and manage samples in the laboratory. LIMS originated nearly 30 years ago as a rudimentary method of automating manual, error-prone processes in the laboratory and, with the growth in adoption of technology, became the de facto benchmark for laboratory control and management.
Getting a clear view of business performance can be cumbersome, time-consuming and even nigh-on impossible.
December 02, 2007
The "why" things are done in this industry is just as important as the "what"and "how."
December 01, 2007
Incorporating quality and economy into downstream purification processes can expedite first-in-human clinical trials, product licensure and technology transfer. Experience in the chromatographic purification of biopharmaceuticals enables the use of downstream processing heuristics to produce target molecules in cost-effective processes suitable for regulatory scrutiny.