PDA Letter

June PDA Letter

Podcast

The July PDA Letter podcast is now available! Hear Hospira’s Sumant Ramachandra and Sandoz’s Joerg Windisch discuss biosimilars in part I and part II of the podcast.

Listen to our previous podcast archive

  • USP <1116> and its Implications for Measuring Microbial Recovery Rates

    by Claudio Denoya, PhD, and Gilberto Dalmaso, PhD, Particle Measuring Systems | May 27, 2015
    The recently revised United States Pharmacopoeia (USP) chapter <1116> Microbiological Control and Monitoring of Aseptic Processing Environments includes a thorough description, definitions and guidance on microbiological control and monitoring in aseptic processing environments (1). Chapter <1116> is arguably one of the most comprehensive informational chapters from the USP, and it is particularly challenging due to its proposal regarding measurement of microbial contamination based on Contamination Recovery Rates (CRR) rather than the conventional enumeration of colony forming units (cfu).
    Full story
  • Inconsistent Expectations Clash with Industry Best Practices for Sterile Products

    by Paul Larocque, Acerna Inc | May 27, 2015
    When it comes to manufacturing sterile drug product, discrepancies exist in the available regulatory guidances/compendial documents and industry best practices that cause tension in the industry. These divergences often affect my recommendations to clients regarding updating or adding new facilities. As examples, I discuss several of these divergent interpretations as they relate to environmental programs.
    Full story
  • New PDA Member’s First Foray to Annual Meeting

    by Janera Harris, Cytonet | May 27, 2015
    In March, I spent a week at the 2015 PDA Annual Meeting in Las Vegas not only learning more about the industry but also interacting and networking with other professionals in the areas of manufacturing and quality.
    Full story

Read the Full June Issue (Members Only)

As the industry moves away from traditional models of manufacturing, having an effective technology transfer plan will be essential.

Science

Visible Particles: Why is This Still a Pain Point?
Deborah Shnek, PhD, Drug Product Development LLC

Rapid Micro Methods: Where Are They Now?
Kim Sobien, BD Rx, and Rebecca Stauffer, PDA

Features

Inconsistent Expectations Clash with Industry Best Practices for Sterile Products
Paul Larocque, Acerna Inc

USP <1116> and its Implications for Measuring Microbial Recovery Rates
Claudio Denoya, PhD, and Gilberto Dalmaso, PhD, Particle Measuring Systems

InfoGraphic: The Future of Aseptic Processing is Now!

Regulation

Teaching Compliance in Financial Terms
Jennifer Magnani and Anders Vinther, PhD, Sanofi Pasteur

PDA Points to Consider on Quality Culture
PDA Quality Metrics Task Force

So Many Reg Questions, So Many Answers
Maria Guazzaroni Jacobs, PhD, Pfizer, and Susan Schniepp, Regulatory Compliance Associates

Cold Chain, Supply Chain Face Changing World Rafik Bishara, PhD, and Erik van Asselt, PhD, Merck Sharp & Dohme