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Equipment qualification is a critical step in ensuring that a product or service is provided accurately and consistently with regards to manufacturing and testing. The time-saving attribute of adding prerequisites to a qualification program, along with the benefit of gaining the ability to track and trend problem areas, make the addition both worthwhile and cost-effective.

The selection of the chiral stationary phase is an important consideration in separating enantiomers when using high-performance liquid chromatography, supercritical fluid chromatography, and simulated moving bed chromatography.

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Report From: India

Differential pricing is making more than just an appearance in Asia's pharma market these days.

Hits and Strikes

Operators are hit hard by breakage problems and strike out on FDA inspections.

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It's back to school. Another summer has flown past and here we all meet again, ready to return to work and face the winter with renewed energies. Welcome back!

The US Food and Drug Administration may soon ask doctors to undergo special training to be able to prescribe powerful narcotics, Dr. Bob Rappaport told The New York Times last week. Rappaport, director of FDA's Anesthesia, Analgesia and Rheumatology Products division, said the agency is considering recommending additional education for doctors in early 2009.

Actavis Totowa LLC, the US subsidiary of the generic drug manufacturer Actavis Group, is announcing a voluntary recall to the retail level of all drug products manufactured at its Little Falls, New Jersey, facility. This is a precautionary, voluntary action by Actavis following an inspection conducted by the Food and Drug Administration earlier this year.