October 2007 Issue

Articles

  • Building a Business Case for PAT

    Securing the support of upper management is essential to the successful implementation of Process Analytical Technology projects. Here, the authors provide a how-to guide.

  • A Synthesis of Cultures

    When executives at Samchully Pharmaceuticals Co. Ltd. (Seoul, Korea) sought out the machinery they would need to expand their oligonucleotides business, they got more than steel and tubing. They forged a trans-global relationship with a U.S. equipment supplier that is introducing them to PAT.

  • How Part 11 Compliance Impacts QbD

    No longer stuck with the "validate everything" mantra, companies now need to assess the risks applicable to their electronic information and integrity to determine what (if any) validation is needed.

  • Leaning on NIR in Pisa

    Italian drug maker Abiogen Pharma S.p.A. has succeeded in saving time and money as a result of applying near-infrared spectroscopy to raw materials characterization.

  • QbD: An Interim Report Card

    The industry and FDA must move towards a cohesive message and methodology to realize the full benefit of QbD.

  • Optimizing Cleanliness & Drainability

    Owners face the prospect of losing millions of dollars each year because of improperly sloped process lines and entrapment in valves and fittings.