Contributing Editors

  1. An Approach And Checklist For Engineering Due Diligence In Pharma M&As
    2/23/2018

    The pharmaceutical industry has evolved dramatically over the past 40 years, constantly changing the manufacturing environment to accommodate products, processes, efficiencies, equipment development, and compliance. All of the companies have changed, and today they more frequently analyze their product portfolio, manufacturing business, and facility efficiencies to rationalize their manufacturing scheme. In addition, the steady rise of contract manufacturing firms has added another dimension to the pharmaceutical manufacturing equation, as those plants expand and renovate to attract and accommodate new manufacturing capability.

  2. An Analysis Of Regulatory Reforms In China’s Pharmaceutical Market
    2/21/2018

    Over the past year, sweeping regulatory reforms have been introduced in China with the aim of encouraging innovation and reducing regulatory burden on the life sciences industry. The breadth of these reforms spreads across multiple stages of the drug development life cycle.

  3. 6 Simple Ways To Get Millennials (More) Invested In Quality
    2/19/2018

    When he was home for the holidays, my 23-year-old son and I had intense, heated discussions about generational differences. We are still on speaking terms, but it got me thinking about how well we understand and value young people — and if we understand the people who make up our future workforce well enough to adequately train them.

  4. An Introduction To Analytical Instrument Qualification & Validation — Meeting FDA Expectations
    2/16/2018

    Analytical instrument can provide a high level of confidence in the integrity and quality of the manufactured product through scientific data, and that confidence can only be achieved through proper instrument qualification

  5. Rapid Growth In Life Science Sector Constrains Capital Projects Supply Chain
    2/14/2018

    According to the latest PharmSource Trend Report, "Bio/Pharma CapEx Trends 2016", biopharma companies have invested over $150 billion in new plants and equipment in the past five years. As this sector continues on an upward trend, it is placing significant pressure on the supply chain.

  6. How To Build A Value-Added GMP Supplier Management Program
    2/12/2018

    Typically, supplier management programs use a supplier survey or an on-site audit to verify if a supplier is compliant with the requirements of a standard or regulation. However, for a supplier management program to provide added value to an organization, the supplier evaluation should look beyond the requirements of a standard or regulation.

  7. Reviewing FY2017 FDA 483s: Training Failures Or A Learning Paradigm?
    2/9/2018

    How do we act on the data of previous 483s? What do we do with that data? Similar to the annual product reviews, we gather data on FDA observations, make graphs, and then … file it away. But there is an alternative.

  8. Why You Should Engage With Regulatory Early In Product Development
    2/7/2018

    The transition from research to product development is a bit more involved than simply adding “&D” to “R.” Involving regulatory affairs early in the development process facilitates definition and execution of the development pathway while considering both regulatory requirements and the company’s business needs.

  9. #MeToo & Time’s Up — Parallels To Reporting Of GMP Compliance Issues
    2/2/2018

    #MeToo and Time’s Up are spotlighting illegal, unethical, improper, and undesirable behaviors and showing that well-established people and businesses can be toppled by their actions. Illegal, unethical, improper, and undesirable behavior exists in the GMP world, too, and we’ve been warned as well.

  10. Quality Risk Management 101: Risks Associated With Medicinal Products
    1/31/2018

    This article marks the first of a series intended to provide a holistic primer on the field of quality risk management (QRM). The series will explore topics including the various types of risks associated with medicinal products, the role of risk management in pharmaceutical and biopharmaceutical regulation, QRM principles and practices, the role of QRM across the product life cycle, primary literature sources for QRM, and common challenges associated with QRM implementation.