Guest Columns

  1. The Shirokizawa Matrix: Determining The Level Of Effort, Formality, & Documentation In Cleaning Validation
    12/11/2019

    The International Congress on Harmonization Quality Risk Management Guidance (ICH Q9) lists both cleaning (in Annex II.4) and validation (in Annex II.6) as potential areas for the application of quality risk management.

  2. Design Of Experiments 101: Understanding DOE’s Foundational Elements
    12/9/2019

    DOE is a very powerful tool that can be easily used to characterize a process. This article discusses several types of experiments, as well as the basic statistical tools and techniques, that can be used when performing a DOE.

  3. FDA FY2019 Drug Inspection Observations And Trends
    12/6/2019

    A comprehensive GMP intelligence program includes monitoring of health authority enforcement actions, including FDA Form 483s, Establishment Inspection Reports, warning letters, recalls, import alerts, consent decree agreements, and EU reports of GMDP noncompliance. This article presents the most recent publication of GMP drug inspection data from CDER, which addresses drug inspections conducted in FY2019. The FDA published data from FY 2018 in September 2019 and we recently addressed that data; FY2019 data was published on Nov. 15, 2019. Here we examine data from FY2019, along with seven years’ worth of trends in drug GMP inspections.

  4. Biocompatibility For Drug Delivery Devices — An Intro To ISO 10993
    12/4/2019

    Biocompatibility is an essential element for any pharmaceutical combination product. ISO 10993 is the standard for biocompatibility, and it is broken into various normative sub-standards from ISO10993-1 to -22 that focus on various assessments, considerations, recommendations, and approaches. 

  5. Executing Signals And Responses In A Continued Process Verification Program
    12/2/2019

    Part 1 of this series provided an overview of CPV and how it is key to setting the foundation for continuous improvement in pharmaceutical manufacturing. In this second part, we will look more deeply into how enhanced knowledge management can enable robust change management in the life sciences industry.

  6. Biosimilars: Lessons Learned From Regulatory Approvals
    11/26/2019

    The EU has approved 16 biological molecules, and the U.S. has licensed the same molecules (including approving some as 505(b)(2) approvals), except for follitropin alfa, which amounts to 114 biosimilars, combined. This article, based on the EMA’s European public assessment reports (EPARs) and the FDA’s BLA (biologics license application) reviews, identifies many inconsistencies that require revision of regulatory guidance to assure faster approval of biosimilars.

  7. Sampling And Testing Of ATMPs: Gaining Insights From PIC/S Annex 2A
    11/26/2019

    With minimal specific guidance on commercial manufacturing from the FDA and a lack of robust platform commercial processes, some of the finer details of cell and therapy manufacturing can make operating companies feel like they are walking on a precarious limb.

  8. Drug Coupons: An Ongoing Debate Between States, Payers, And Manufacturers
    11/22/2019

    The clock is ticking for state lawmakers to preserve an existing law that allows for prescription drug coupon usage in Massachusetts with an end-of-the-year deadline fast approaching.

  9. Improving Biopharma Packaging Line Efficiency Through Overall Equipment Effectiveness (OEE)
    11/20/2019

    While the boipharmaceutical industry has benefited from high margins and low competition for decades, operational efficiency remains a low priority item for packaging departments in life sciences..

  10. Can The FDA Salvage Interchangeable Follow-On Biologics?
    11/19/2019

    Learn the statutory and regulatory requirements for interchangeability designation, how the designation hampers follow-on biologics, and why the FDA should loosen requirements for the designation.