FDA White Papers & Case Studies

  1. Signature Requirements For The eTMF 2/19/2013

    Sponsors and CROs want to ensure that the processes and workflows they use in their electronic Trial Master Files (eTMF) comply with all regulatory requirements, resulting in a robust system that will produce complete documentation able to withstand an agency audit. To provide a solid basis for decision-making, we’ve researched both the regulatory basis for signatures and the technology implications around how to collect signatures. Since the goal of any eTMF system is to streamline processes and increase compliance, implementing valid signature processes in the least cumbersome manner is always of concern.

  2. An Introduction To The Challenges Presented By Product Codification & Serialization In The Pharmaceutical Sector 10/25/2012

    It is well recognized that the counterfeiting of pharmaceutical drugs and medical devices is a real and constant threat to patient safety. It is a global issue that affects all of us. By Darren Atkinson

     

  3. What To Expect When They’re Inspecting – Part II 7/31/2012

    The first segment of this series focused on some of the nontraditional variables that can have an effect on any FDA inspection, and how to achieve a positive outcome regardless of the inspectional conclusion. That article generated some blog discussion on FDA's objectivity. I wanted to clarify some of those issues.

  4. Weathering The Storm Of Regulatory Compliance In Aseptic Manufacturing 7/30/2012

    When the U.S. Food and Drug Administration (FDA) conducts an unscheduled inspection of your aseptic manufacturing process, it can hit with the fury of a New England nor’easter. But just as careful planning and forecasting help us safely ride out the storm, a best-practice control and monitoring system minimizes the danger of FDA noncompliance. By Alex Mello, Microtest

  5. California 2015 Serialization & e-Pedigree: Strategic Planning 5/30/2012

    Those that have heard me speak at industry events, private management workshops, or webinars know that I am always asking “What can we do better?” The “We” is you, the client, and PharmTech. By Michael Stewart

  6. Accelerating Generic Approvals: 5 Keys To Being First To Market 12/12/2011

    Competition in the generics market has never been greater. At a time when many of the most successful drugs are reaching the patent cliff, opening the floodgates for generic substitutes, generic companies are rushing to target the best candidates and enter the market first.

  7. Evolving From Cold Chain Logistics Management To Cold Chain Logistics Control 9/7/2011
    Particularly for companies involved in the life sciences, the entire field of cold chain logistics has undergone significant changes in a relatively few years.
  8. Sterile Drug Products Produced By Aseptic Processing — Current Good Manufacturing Practice 7/28/2011

    This guidance is intended to help manufacturers meet the requirements in the Agency's current good manufacturing practice (CGMP) regulations (2l CFR parts 210 and 211) when manufacturing sterile drug and biological products using aseptic processing. By PharmaSystems, Inc.

  9. GlaxoSmithKline Ltd., Cork, Ireland 6/29/2011
    GlaxoSmithKline is one of the world’s leading researchbased pharmaceutical and healthcare companies with a share of approximately 5% of the world’s pharmaceutical market. By Beamex
  10. AstraZeneca Ab, Sweden 6/29/2011
    Sweden Operations is AstraZeneca’s largest production and product support unit, and the majority of production facilities are located in Södertälje. The largest tablet factory in the world is located here. By Beamex