Contributing Editors

  1. How To Establish Growth Promotion Tests For Pharmaceutical Culture Media
    1/7/2019

    The article discusses some of the guidance documents and regulatory expectations regarding media growth promotion and provides guidance on establishing a compliant growth promotion test.

  2. Strategies For Implementing An Improved Change Management Process
    1/4/2019

    In the first article of this two-part series, we provided an overview of a co-creation model for change management and the tools and methodologies that form the foundation for improved change management. This second part will look at strategies for implementing an improved change management process.

  3. FDA’s New Data Integrity Guidance — Highlights & Observations
    1/2/2019

    The FDA recently posted the final guidance Data Integrity and Compliance with Drug CGMP Questions and Answers, finalizing a draft first published in April 2016. This article provides an overview and analysis of the guidance's 18 questions, which span the broad areas of data integrity and data governance.

  4. Why Now Is The Time For An Aseptic Processing Revolution
    12/27/2018

    This article is the first in a three-part series exploring the need and means to achieve improvement in aseptic processing of sterile biopharmaceutical products. Part 1 presents the current state and opportunity for improvement using innovative technology. Part 2 further discusses some of the changes in strategy that might be needed for and result from the use and improvement of technology. Part 3 presents the impact of technology changes.

  5. “The 12 Months Of Quality:” Tips For Building A Voluntary QA Culture In 2019
    12/26/2018

    Rather than 12 days of gifts, here are 12 months of suggestions to assist you in helping your organization bring its quality efforts and programs to the next level. As you think about where you want to be in 2019, consider these thoughts as strategies for building more credibility, cachet, and value around quality.

  6. 3D Printing In The Pharmaceutical Industry: Where Does It Currently Stand?
    12/21/2018

    In 2015, Aprecia Pharmaceuticals produced the first tablet manufactured through 3D printing to be approved by the FDA. Now, with applications in controlled release, short-run medicines, and even the potential for on-site printing at pharmacies, 3D printing technology has the ability to transform the pharmaceutical industry.

  7. New FDA Powers Under The SUPPORT Act — What Pharma Manufacturers Need To Know
    12/19/2018

    Drug manufacturers should be aware of new regulatory powers given to the FDA in a recently enacted law aimed at deterring opioid abuse. The Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act (SUPPORT Act) became law on Oct. 24, 2018 with bipartisan support in both the House and the Senate.

  8. An Intro To Tools And Methodologies To Improve Change Management
    12/17/2018

    This is the first in a two-part article describes a change management model derived from the concept of co-creation, a process in which brands and consumers work together to create better ideas, products, and services. This first part discusses the tools and methodologies that provide a foundation for improving change management.

  9. Does Quality Even Matter? 10 Things Quality Departments Should Stop Doing
    12/13/2018

    Senior quality leaders and the FDA agree quality organizations supporting pharma manufacturing often fall short of providing the support necessary to maintain and increase regulatory compliance and product quality. At the same time, some do not understand their actions and believe they are obstructionist and reflective of a strict compliance mentality with little regard for the business and its success.

  10. 4 Ways To Prevent Manufacture And Distribution Of Substandard Medications
    12/12/2018

    If a legitimate product is not manufactured according to quality standards or becomes degraded as it travels through its supply chain, it can be ineffective at best or deadly at worst.