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August 02, 2005
Our GMP Agent-in-Place at a top-10 pharmaceutical manufacturing firm reports on a spill during the manufacture of a time-release capsule filled with coated beads.
August 01, 2005
Cold chain management is becoming pivotal to success in the pharmaceutical industry.
API and fine chemicals companies in Asia are flexing their muscles in a bid to increase their market share in key territories. This has been demonstrated by India's Malladi Drugs and Pharmaceuticals, which earlier this summer acquired Novus, a US company, to boost its presence in the pseudoephedrine (an ingredient used in cough and cold formulations) market. Reportedly, this is the first time (and it certainly won't be the last) that an Indian API manufacturer has bought a US counterpart and drives home the message that Indian companies are looking at providing products on a global scale. The deal gives Malladi an almost vice-like grip on a third of the global pseudoephedrine market, and more importantly, a foot in the lucrative US sector.
More and more often, manufacturers in need of outside services are turning to preferred providers.
July 02, 2005
Police and protests at BIO 2005.
The industry should develop a set of best practices for managing information technology systems and not wait for FDA to take the lead.
June 02, 2005
A myopic focus on short-term growth can endanger the community. The question is, can we enlighten our self-interest before the edifice falls down around our ears?
In his Feb. 2005 viewpoint article, "In Defense of Singlet Testing," Torbeck (1) draws an important philosophical distinction between "standards" and "specifications." He argues that specifications are criteria selected by manufacturers for statistical control of their products, whereas compendial standards are absolute requirements. This distinction is entirely compatible with modern concepts of statistical process control.
June 01, 2005
Detection and identification of different polymorphic forms is, therefore, important throughout the drug development and manufacturing process.
HR-US is a nondestructive technique with enormous potential for the analysis of materials and formulations used in the pharmaceutical industry.