Guest Columns

  1. Outsourced Manufacturing Considerations For M&A Technical Due Diligence
    5/25/2017

    My previous article on the regulatory and quality aspects of M&A technical due diligence looked at how to ensure you acquire products that can be outsourced properly to a third-party manufacturer. This second part will cover considerations for the manufacturing process and equipment as well as some aspects of logistics and operations.

  2. Developing Mobile Continuous Process Technology: A Collaborative Innovation Case Study
    5/24/2017

    In Part 1 of this two-part article, we explored the role of open collaboration in the future pharmaceutical manufacturing innovation. Part 2 provides a specific example of how such collaboration is already taking place, through a unique industry-academic partnership.

  3. An ADE-Derived Scale For Assessing Product Cross-Contamination Risk In Shared Facilities
    5/22/2017

    Beginning in 2004, a global team of pharmaceutical toxicologists, industrial hygienists, quality assurance professionals, a cleaning validation professional, and a representative from the US FDA participated in the development of the International Society for Pharmaceutical Engineering's (ISPE) Risk-Based Manufacturing of Pharmaceutical Products (Risk-MaPP) Baseline Guide.

  4. Beyond The FDA Guidance: Practical Considerations For Quality Agreements
    5/19/2017

    Much has been written in recent months about the FDA’s final guidance for industry, Contract Manufacturing Arrangement for Drugs:  Quality Agreements, issued in November 2016.  Recently, a thorough assessment of the guidance requirements and gaps was published on this website. (See FDA's New Quality Agreement Guidance — What It Says (And What It Fails To Say) and Examining FDA's New Quality Agreement Guidance.)

  5. Engaging A Life Science Consultant: Common Pitfalls & Best Practices
    5/12/2017

    This article summarizes insights gleaned from interviews with multiple consultants, each of whom has at least 25 years’ experience in the life sciences space — and from conversations with the life science companies who hire such consultants to ensure that their systems meet the product quality attribute/specification requirements mandated by their respective regulators.

  6. 9 Steps To Train Your Personnel To Think Beyond The SOP
    5/10/2017

    We need to teach people how to think again. Then, we need to encourage them to think on a day-to-day basis so that they’re comfortable with it when a problem arises that requires out-of-the-box, beyond-the-SOP thinking. 

  7. An Introduction To qFMEA – A Tool For QMS Risk Management
    5/8/2017

    Probably the most significant concern for anyone responsible for implementing, deploying, and maintaining a quality management system is the integration of risk-based thinking. This article is an expansion on the idea presented by John Vanhouwe, QA manager at IAC Group, in his article Risk Based Thinking: Making Use of a New FMEA Tool Called O-FMEA.

  8. Handling & Processing Of Potent Compounds: A Holistic Approach
    5/5/2017

    The topic of potent compounds may seem obscure; however, it touches virtually every aspect of the biopharmaceutical business, from selection pressure in media to antibody-drug conjugates (ADCs). Every chemical and biological compound we work with has an MSDS (material safety data sheet) and an OEL (occupational exposure limit), which dictate how we must handle the compound and bring to the forefront issues of personnel safety and environmental impact that we must address in our manufacturing plants. When designing a process involving any potent compound, there are three aspects we must address directly: facilities, processing equipment, and people.

  9. Are "Do-Overs" Practical In Biopharmaceutical Manufacturing?
    4/28/2017

    What should a manufacturer do when an API (drug substance) or intermediate from a biopharmaceutical manufacturing process does not meet specification, or when a process has operated outside the validated operating range? 

  10. Is Open Collaboration The New Paradigm In Pharma Manufacturing Innovation?
    4/26/2017

    How can we reduce these risks and increase the success in adopting new technologies and better supply chains? Part of the answer is better collaboration between industry, academia, and government.