PDA Letter

July August PDA Letter


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  • Industry, FDA Still Wary of Supply Chain Security

    by Marla Phillips, PhD, Xavier University, Mee-Shew Cheung, PhD, Xavier University, Vishal Kashyap, PhD, University of Graz | Jul 07, 2014
    Public confidence in pharmaceutical products has waned in recent years based on patient harm caused by adulteration, drug shortages and poor quality resulting in recalls. Along with concern for patient safety, pharmaceutical professionals at all levels within their organizations have become keenly aware of the potential for damage to the company brand by such incidents.
    Full story
  • Outsourcing Management: Key Component of a QMS

    by Miguel Montalvo, Expert Validation Consulting | Jul 07, 2014
    Regulatory agencies hold firms responsible for delivering high quality products that meet all established requirements and specifications. Suppliers and vendors (most recently referred to as “outsourced materials and services”) play a key role in meeting GMP mandates, and it is a firm’s responsibility to make sure vendors/suppliers are meeting specifications for the supplied materials, components, equipment and/or services. For many years, this was considered to be an “internal GMP compliance” responsibility, managed by internal controls in most cases.
    Full story
  • The Value of PDA Technical Reports

    by Stephan O. Krause, PhD, MedImmune/AstraZeneca | Jul 07, 2014
    In February 2014, the U.S. FDA published the draft guidance, Analytical Procedures and Methods Validation for Drugs and Biologics. Once finalized, this 2014 draft guidance will replace the 2000 FDA draft guidance, Analytical Procedures and Methods Validation. I want to highlight the development of PDA Technical Report 57: Analytical Method Validation and Transfer for Biotechnology Products, and its influence on the content of the new FDA draft guidance.
    Full story

Read the Full July August Issue (Members Only)

Follow the logo for the 2014 PDA/FDA Joint Regulatory Conference to locate articles relating to this important forum. Marla Phillips discusses Xavier University’s Integrity of Supply Chain Initiative. Miguel Montalvo explores how CMOs and their clients can work together on effective quality management practices. And Joachim del Boca talks to Robert Darius about his over 30 years’ experience working for a CMO. Also, check out our selection of excerpts from recent PDA publications for some summer reading before you hit the beach!