November/December 2006 Issue

Articles

  • Analyze This!

    The 450-page Pharmaceutical Manufacturing benchmarking study released in October offers a gold mine of information on how to improve, for those industry professionals and regulators brave enough to dive into the data. In this feature, Jeff Macher and Jackson Nickerson discuss challenges they faced, study results, a major caveat and future plans.

  • From the Editor: Into the Light

    Drug manufacturing can only advance if drugmakers, regulators, academics and vendors join forces to mine and interpret new data.

  • Tech Transfer: Don't Fumble the Hand Off

    Technology transfer was once taken for granted as something that would “get done anyway.” Now it’s an indicator of manufacturing excellence and a core competency for drug innovators.

  • On-Line TOC: Will Marketing or Science Prevail?

    As new players enter the market and a standard is proposed to ASTM’s E-55 committee, a great deal of controversy is swirling around on-line TOC analysis for pharmaceutical-grade water. The world’s leading technical experts are aligned with one vendor or another, so it’s up to the user to filter through the marketing-speak and determine which technology will best meet specific installation needs.

  • Validating On-Line TOC Analyzers for Real-Time Release

    Robust analytical TOC method validation is essential to the success of any on-line TOC system, particularly systems that release pharmaceutical-grade water in real time. Meeting USP 643 or EP 2.2.44 specifications may not eliminate risk.