Industry Insights

  1. Embracing Turnkey And Outsourced Quality Management In Biopharma 3/28/2025

    In-house quality management systems often struggle to keep pace. Many organizations are adopting turnkey and outsourced quality management solutions to ensure compliance and enhance efficiency.

  2. Put Your Continued Process Verification (CPV) Data To Work 5/22/2020

    Though the FDA’s process validation guidance has been in place for over a decade and other regulatory agencies (EMA, WHO, PIC/S) continue to accept the continuous process verification (CPV) concept, adoption has been slowed by the data governance, analytical capability, and technology challenges.

  3. Survey Results Show What Could Finally Make Sustainability Stick 9/8/2023

    Results from BioPlan's "20th Annual Report of Biopharmaceutical Manufacturing and Production" show that lasting sustainability strategies should focus on profitability aspects. That's because, even more than a spirit of stewardship, financial advantages provide a powerful incentive to stick to the plan.

  4. Development And Manufacturing: Success With HPAPI

    Dr. Michiya Hayakawa shares strategies for manufacturing HPAPI (highly potent active pharmaceutical ingredient) drugs and key points for promoting projects that utilize special formulation technologies.

  5. Juno v. Kite: Implications For Functionally Claimed Biologics 11/12/2021

    The Federal Circuit recently reversed a jury verdict in the case Juno Therapeutics, Inc. v. Kite Pharma, Inc.., wiping out a $1.2 billion judgment for Juno in the lower court by invalidating claims directed to the functional properties of biological compounds that could be used as therapies. What does this mean for biologics developers going forward?

  6. The 7 C's Of A Compliant Manufacturing Change Control System 2/8/2023

    Change control is integral to continuous quality improvement and customer satisfaction. Learn about the manufacturing change control process, its requirements, and the characteristics a change control system should possess.

  7. Avoid These 29 API Manufacturing Deficiencies 7/17/2023

    Most API manufacturers are constantly improving their processes, but mistakes still happen. This list of deficiencies from the GMP Compliance Adviser explains what to watch out for.

  8. 5 Steps To Eliminate Weak Links In Your Data Governance 12/2/2022

    Major regulators including the FDA and EMA have established frameworks through which data must be captured and exchanged with them. But your pharma, biotech, or medical device company needs a solid plan for how that data will be governed.

  9. Making it Happen: Project Considerations For Artwork Improvement Programs 3/10/2014

    By Stephen McIndoe BEng CEng MIET, VP Consulting, Be4ward

    In my first two articles in this series on change and program management of artwork improvement projects, I talked about some of the issues that need to be considered when setting up an artwork capability improvement program and some of the change management aspects to consider in order to ensure the change is delivered in a sustainable way.  In this article, I will look at the design of individual improvement projects to ensure effective delivery.

  10. FDA Issues Pandemic Remote Inspection Guidance For Drug Manufacturing Facilities 5/3/2021

    On April 14, 2021, the FDA released a new guidance, Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities During the COVID-19 Public Health Emergency. This article discusses planning, conducting, and concluding a remote interactive evaluation under this guidance, and shares how to submit public comments for FDA consideration.