Pharmaceutical Technology-01-02-2006

The benefits of zero tolerance as a test criterion have been oversold. A critical examination of zero tolerance reveals that many of the supposed benefits are not attainable. More important, inappropriate application of this criterion can have a deleterious effect on the assessment, control, and improvement of the quality of pharmaceutical products.

New tubing specifically designed for peristaltic pumps has been introduced by Maztech (Elkton, MD, www.smartshieldtubing.com).

It's impossible to watch the evening news without seeing an update about the robustness of this year's influenza strains and the potential threat of the avian flu. Given the staggering mortality rate (about 52%) among human avian flu victims, I can't help but straighten up and listen to the reports as a knot develops in my stomach.

Is the recent round of Big Pharma plant closings a sign of regrowth?

The big question for pharmaceutical services providers coming into 2006 is: will the good times continue to roll?

It's time for the pharmaceutical industry to consider electronic innovations as part of their life cycle management strategies.

Using the Bergum Method and the MS Excel software program, the author determines the probability of passing the USP dissolution test.

Manufacturers, FDA, and research organizations are collaborating on efforts to spur innovation and streamline drug production.

Hot melt extrusion (HME) formulation development depends heavily on choosing the appropriate polymers. This article reviews HME process parameters and highlights three polymers in HME: polyethylene oxide, ethylcellulose, and hypromellose.

In the second half of this two-part series, the author suggests that to qualify and validate a pharmaceutical manufacturing facility, one must coordinate protocol and SOP development, scheduling and implementation, turnover package preparation, and the management and resolution of deviations and discrepancies. In combination with the programs described in Part I, these activities will help deliver projects on schedule, at estimated cost, and with quality assured.

Merck (Whitehouse Station, NJ, www.merck.com) has revealed the "first phase" of its global restructuring program set to eliminate 7000 jobs (11% of its global workforce) by the end of 2008, close or sell 5 of its 31 manufacturing facilities, and roll out a manufacturing strategy to "drive significant efficiencies, decrease headcount, and reduce or refocus operations throughout the plant network and the entire manufacturing division." The company also expects to close one basic research site and two preclinical development sites.

Contract manufactures are faced with multiple challenges when determining whether to implement process analytical technology into their clients' or their own infrastructure.

A particular dermatological product was packaged in a metal tube, which is filled from the bottom.