Contributing Editors

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

    This article shows how health-based exposure limits (HBEL)-based and process capability-based scales can be combined into a matrix that provides a clear visual guide for adjusting the level of effort, formality, and documentation for cleaning validation based on the level of risk.

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

    DOE is a very powerful tool that can be 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.

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

    This article presents the most recent publication of GMP drug inspection data from CDER, published November 15, 2019 and addressing drug inspections conducted in FY2019. We'll also take a look at seven years’ worth of trends in drug GMP inspections.

34. ISO 10993: Considerations For Drug Delivery Devices 12/4/2019

    A host of factors come in to play when evaluating biocompatibility, including how the medical device is sterilized, how the device is used, what body parts it makes contact with, and selecting testing approaches.

35. 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.

36. 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.

37. 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..

38. Process Characterization: The Foundation For Validation 11/18/2019

    Process validation should never be performed until the process is fully characterized. A failed process validation should be a rare event; otherwise, a Warning Letter will probably be in your future.

39. People: The Most Persistent Risk To Data Integrity 11/15/2019

    HR changes continually impact overall data integrity—from a single new hire to a corporate-level change with a merger or acquisition. It's a commonly overlooked weak link in the data integrity chain.

40. Pigeons In The Plant: 10 Real-Life Pharma Facility Blunders (And How To Avoid Them) 11/13/2019

    There are situations we have come across where we really scratch our heads and say, “What did they just do, and what were they thinking?” This article describes a series of events and activities that we have seen that are at once amusing, baffling, and revealing of the flaws in our industry.