Viewpoints

Technology's new monthly "Agent-in-Place" column distills true-life cautionary tales from the secret files of Control, a senior compliance officer.

Lean is good. Emaciated is something else.

Because disposable systems offer benefits that can impact the time for development as well as for the cost of production, the biotech sector is expected to continue to use these technologies ...

As one Midwestern city has discovered, there is life after Big Pharma.

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.

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.

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.

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.

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.

Possible cross-contamination issues should be eliminated at the early stage of the project. The project sponsor should ensure that all relevant personnel from the production, quality control, logistics, and maintenance departments, as well as engineering, are involved in the conceptual stages of a design.

This high quality of pellet roundness is surprising in view of the high extrusion forces required to extrude the wet masses.

Pharmaceutical Technology has joined with INTERPHEX to found GenerationNext, an award program to recognize emerging leaders in pharmaceutical science and technology.

While Europe's political leaders were paying lip-service to creating a more competitive Europe at their spring summit in Brussels, European pharmaceutical technologists were tackling the serious business of turning political rhetoric into practical reality.

Improved products and processes that are cleaner, less expensive, more manageable and take up less space are benefits that you would expect to be snapped up by any industry. But not so in pharmaceutical manufacturing, where traditional methods prevail.

To help reduce the risks of operator exposure and process cross contamination of powdered materials in the pharmaceutical manufacturing environment, the International Society of Pharmaceutical Engineering (ISPE) has published ISPE Good Practice Guide: Assessing the Particulate Containment Performance of Pharmaceutical Equipment.

The C-SOC team must develop a network of committed industrial partners who will participate in the direction, execution, and evaluation of research and educational activities.

What the industry needs most is not reduced oversight. What we need is, competent, constructive, informed, consistent, fair, and predictable inspection.

Pharmaceutical packaging can no longer be an afterthought in pharmaceutical product development.

In this time of liability reform, pharma deserves the chance to align its economic interests with its ethical obligations to the patient.

Steer small.

Committees make prudent decisions and avoid mistakes, but they're afraid of the new.

On the other hand, if we don't keep up the pressure on counterfeiting in the US, we may share the plight of the developing world, where nearly 25% of all drugs sold are fakes.

Amid the finger-pointing, hand-wringing, and bloviating, the supply of hard, technical information remains frustratingly small.

Beyond the inevitable debate over profit margins, the increasing range and effectiveness of modern medicine leave us with one core issue: the high price of success.