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  • FDA FY2019 Drug Inspection Observations And Trends
    FDA FY2019 Drug Inspection Observations And Trends

    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.

  • Biocompatibility For Drug Delivery Devices — An Intro To ISO 10993
    Biocompatibility For Drug Delivery Devices — An Intro To ISO 10993

    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. 

  • Executing Signals And Responses In A Continued Process Verification Program
    Executing Signals And Responses In A Continued Process Verification Program

    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.

  • Drug Coupons: An Ongoing Debate Between States, Payers, And Manufacturers
    Drug Coupons: An Ongoing Debate Between States, Payers, And Manufacturers

    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.

  • Improving Biopharma Packaging Line Efficiency Through Overall Equipment Effectiveness (OEE)
    Improving Biopharma Packaging Line Efficiency Through Overall Equipment Effectiveness (OEE)

    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..

  • Process Characterization: The Foundation For Validation
    Process Characterization: The Foundation For Validation

    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.

  • People: The Most Persistent Risk To Data Integrity
    People: The Most Persistent Risk To Data Integrity

    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.

  • Pigeons In The Plant: 10 Real-Life Pharma Facility Blunders (And How To Avoid Them)
    Pigeons In The Plant: 10 Real-Life Pharma Facility Blunders (And How To Avoid Them)

    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.

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This free collection of articles is from the Data Integrity In The Life Sciences series, the purpose of which is to highlight contemporary insights and relationships to key quality systems in order to elevate the most important topics and advance improvements in the collective quality culture.

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