Industry Insights

  1. Can Today's ELNs Support Tomorrow's Labs? 3/14/2024

    The global electronic laboratory notebook (ELN) market is growing, however, ELNs must form part of a more comprehensive data strategy and ecosystem or they can impede progress.

  2. Chief Quality Officers: Redesigning Quality For The 21st Century 3/27/2019

    With input from FDA and regulators, CQOs are pursuing means to analyze huge data sets, manage complex manufacturing systems, and operate smoothly between varied products, languages, and cultures.

  3. Back To Basics: 505(b)(2) FAQs Part 1 8/27/2021

    The topic of this post will be general 505(b)(2) questions, including what is and is not allowed for an approval via the 505(b)(2) regulatory pathway.

  4. How You Should Prepare For Foreign FDA Inspections

    Ensure you understand the expectations of regulators and what you can do to facilitate successful paper-based inspections in lieu of those performed on-site.

  5. The Unsung Heroes Of Drug Development: Small Pharma-Service Entrepreneurs Make A Big Impact 12/23/2020

    It seems those technical entrepreneurs from decades past who built the thriving outsourced pharma services industry we see today have themselves been merged into retirement as their organizations have become part of the bigger global contract pharma machine. So, is there a next generation of entrepreneurs building the next crop of successful smaller firms that will grow to fill this void?

  6. Why The FDA General Calibration Requirements Are Not Enough 4/10/2024

    Calibration is a niche industry that is not well understood by many. By choosing an ISO 17025-accredited organization, companies can benefit from external auditing and adherence to accepted standards.

  7. 5 Priorities For Manufacturing Software 4/6/2022

    Learn where modern manufacturing execution software can, and should, provide the essential functionality needed to address pharmaceutical and medical device manufacturers’ pressing production needs.

  8. Gas Ingress Methods As Replacement Of Blue Dye Ingress Testing For Container Closure Integrity 3/10/2021

    This article describes the headspace gas ingress testing approach which is increasingly being implemented to replace blue dye ingress as a general CCI test method.

  9. Measuring Filter Performance—It's More Than Just A Label

    How is the performance of a filter measured? Learn why the micron rating is an incomplete measure of filter performance, why the beta-ratio is a more accurate indicator, and more.

  10. Demystifying Lyophilization: Understanding The Freeze-Drying Process 5/23/2024

    Advancements in lyophilization technology and research have helped overcome inherent challenges and ensure the safety and efficacy of lyophilized pharmaceuticals.