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  • Realizing ERP’s Untapped Potential

    Pharma ERP has been an underachiever for years; savvy drug makers are turning that picture around by connecting ERPs more closely to the plant floor.

    Doug Bartholomew, Contributing Editor
  • Chiron's Curse

    Its U.K. vaccine plant has been a nightmare. Could better risk management, due diligence, regulatory oversight or new technology have led to a different outcome?

  • PAT: The Value of Better Control

    Model Predictive Control (MPC) and better sensor technologies will allow pharmaceutical companies to better control their processes. Pavilion Technologies’ Eric Unrau and Michael Tay discuss the challenges and benefits of implementing MPC for pharmaceutical processes.

  • Use In-House Techniques to Minimize Implementation Costs

    Before investing in new instrumentation, be sure that you already have what you need to gain the process knowledge that PAT requires. Richard Poska, director of global pharmaceutical regulatory affairs for Abbott Labs’ CMC, GPRD Support, Small Molecules, shares his insights.

  • BMS Aims High Through Benchmarking

    Bristol-Myers Squibb benchmarked against the leanest, most agile consumer goods companies to transform its supply chain management processes and culture.

  • A Process Capability Roadmap

    The unexamined process cannot be improved, and process capability analysis offers new insights. Quality systems specialist Scott Tarpley, a consultant with Light Pharma, outlines the steps involved and prerequisites.

  • Whistleblower in Wyeth Case Speaks Out

    GMPs and financial disclosure are two sides of the same coin, claims Mark Livingston, plaintiff in a much-publicized whistleblower lawsuit against Wyeth Pharmaceuticals, in this exclusive reprint of a recent speech.

  • Process Optimization: From Petrochemicals to Biopharmaceuticals

    Bayer is using simulation and a Six Sigma DMAIC approach to adapt petrochemical process optimization techniques for biopharmaceuticals. Thomas Daszkowski, Sanjay Joshi, and Peter Ryan of Bayer Technology Services discuss what they’re doing and the progress they’ve made.

  • PAT Provides New Insights Into Drying

    Vendors, manufacturers team up to roll out the latest in mass and NIR spectrometers, effusivity sensors and other PAT-worthy technologies.

  • How Capable Are Your Processes? Do You Know?

    The industry needs to understand its manufacturing processes if it is to transform them and better serve its ultimate consumer, the patient, asserts G.K. Raju, CEO of Light Pharma, Inc.

  • The Long Arm of S88

    Batch automation standards are having an impact far from the control room, changing approaches to plant design, specification, and validation

  • Risk Management Still Eludes Vaccine Manufacturers

    Despite the buzz about "process understanding" and PAT, vaccine manufacturing remains defiantly un-PAT-able and an extremely risky business. Chiron's recent Fluvirin case offers important lessons in due diligence, quality management, and GMPs. However, it also points out an urgent need for incentives and regulatory flexibility.

    Agnes Shanley, Editor in Chief
  • Therapeutic Dose: Manufacturing Phil: A Drug's Life

    A Pfizer public education campaign and its cute mascot are praiseworthy, but neglect to mention the key stage in a drug's life. What will it take to make manufacturing a hot button issue and to better educate the public?

    Paul Thomas, Managing Editor
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