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  • Will USP and FDA Reach Consensus on Stability Testing?
    tablets are an imperfect solution, and only illustrate the imprecision of stability testing today. As professors Piero Armenante (from New Jersey Institute of Technology) and Fernando Muzzio (of Rutgers) demonstrated in a recent report to FDA, hydrodynamics within testing equipment can cause tremendous
  • Safe Materials from Overseas: What Tools Does FDA Have?
    By Emil W. Ciurczak, Contributing Editor With all the recent interest in the safety of raw materials and intermediates sourced from off-shore locations, what tools are in the pocket of a typical FDA inspector? Having cut my teeth in the pharma world, the phrase "The FDA is coming to audit us
  • How Early Communication with FDA Sped Up One RMM Implementation
    , and communicating proactively with FDA. At the Lean Pharmaceutical Manufacturing conference in Princeton, N.J. on Nov. 9, Rich Boehler, Microbiology Group Leader with Luitpold Pharmeceuticals Inc., discussed his experiences as part of an RMM implementation for a major pharmaceutical company earlier
  • FDA's Chris Watts on New Directions for PAT at FDA
    the characterization all the time that we ve dropped this test or dropped that test, and that s not the case at all. We ve not dropped anything but simply moved the analysis and control on line or in line. You don t necessarily need the lab analysis. You re doing 1000
  • FDA Report Supports Use of RFID
    for a group that will explore the use of RFID and electronic product code (EPC) in the pharmaceutical supply chain. Group members include Abbott Laboratories, Barr Pharmaceuticals, Pfizer, Johnson & Johnson as well as distributors, retailers and trade groups. The group plans to test how RFID can
  • Medical Device Link . Managing Positive Biocompatibility Test Results Nancy J. Stark
    while conservatively managing resources. Neither ISO 10993-1 nor the FDA memorandum on its use specify pass/fail criteria for biological testing, recognizing that it is almost impossible to set general criteria and that manufacturers are in the best position to determine what level of toxicity
  • Interphex Stands Test of Time (and Economy)
    facility was purchased from Wyeth Pharmaceuticals and has a long-standing history of compliance with the FDA and a proven workforce. Alfa Laval is a global manufacturer of specialized equipment and engineered process solutions, with a commitment to modular process solutions for unit operations
  • Critical Path to Establish Performance Test Standards for Diagnostics
    with diagnostics developed by Ventana Medical Systems, also based in Arizona, but these performance standards could be available for all relevant diagnostics. Resulting standards could provide FDA with greater assurance of the reliability of new diagnostic tests and could, thus, help the FDA evaluate

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