Pharmaceutical Technology-01-02-2006

Pharmaceutical Technology

Zero-Tolerance Criteria Do Not Assure Product Quality

January 01, 2006

Articles

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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.

Flu 2006 Spurs Paranoia and Innovation

January 01, 2006

This Time Around

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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.

Hypromellose, Ethylcellulose, and Polyethylene Oxide Use in Hot Melt Extrusion

January 01, 2006

Articles

30

1

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.

Essentials of Validation Project Management

January 01, 2006

Articles

30

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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.

January 2006

January 01, 2006

In the Field

30

1

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.