GUEST COLUMNISTS

  • An Introduction To Prefilled Syringe Selection — Prefilled Syringes With Staked-In Needles
    An Introduction To Prefilled Syringe Selection — Prefilled Syringes With Staked-In Needles

    This is the second part of a two-part article exploring various types of prefilled syringes (PFSs) for biopharmaceutical products. Part 1 looked at needle-free and dual-chamber prefilled syringes, discussing the important aspects of those devices. In this part, we will examine the various aspects of prefilled syringes with staked-in needles and their impacts. We will conclude with some general thoughts on vendor selection for successful partnership.

  • ISO 22519: An Unnecessary, Faulty, And Confusing Standard
    ISO 22519: An Unnecessary, Faulty, And Confusing Standard

    The ISO Standard 22519 claims to be the new word in purified water (PW) compliance. In fact, the standard neither promotes innovation nor compliance. On the contrary, it brings confusion to those that are embarking on purified water production and use in the pharmaceutical industry.

  • A Due Diligence Checklist For Leasing A Biotech Manufacturing Facility
    A Due Diligence Checklist For Leasing A Biotech Manufacturing Facility

    The road to successfully acquiring a property for a biotech startup is littered with potholes and barriers. After the operating organization decides that leasing is the most economical approach, the search should focus on the technical merit of the property and the features it offers. This article provides a technical due diligence checklist that the operating organization can use to frame its decision-making process.

  • FDA FY2018 Drug Inspection Observations And Trends
    FDA FY2018 Drug Inspection Observations And Trends

    The FDA recently published GMP drug inspection data from CDER that addresses drug inspections conducted during the agency's 2018 fiscal year. This article examines the FY2018 data and evaluate six years’ worth of trends in FDA GMP inspection enforcement.

  • Comparing U.S. & EU Guidances On Combination Product Approval ProcessES
    Comparing U.S. & EU Guidances On Combination Product Approval ProcessES

    New EU draft guidance, Guideline on the quality requirements for drug-device combinations, and U.S. draft guidance, Principles of Premarket Pathways for Combination Products, are the latest attempts to regulate combination products. In Part 2 of this series, we cover the EU guideline and show how two diverge.

  • Facilitating Data Integrity Through Risk-Based Confirmation Of Performance
    Facilitating Data Integrity Through Risk-Based Confirmation Of Performance

    We in pharma and biopharma are required to verify or check or double-check an action or event to be sure it was performed and performed correctly. But what do these words really mean? How do they differ in terms of their actual execution?

  • Pharma 4.0: Building Quality Into Pharma Manufacturing, From Molecule To Medicine
    Pharma 4.0: Building Quality Into Pharma Manufacturing, From Molecule To Medicine

    A race is being run to create the pharmaceutical manufacturing of the future and with Pharma 4.0, powerful market trends are shaping the running field.

  • An Intro To Prefilled Syringe Selection: Needle-Free And Dual-Chamber Devices
    An Intro To Prefilled Syringe Selection: Needle-Free And Dual-Chamber Devices

    This two-part article will provide an introduction to the three general prefilled syringe (PFS) types and will share important factors to take into consideration for your drug product. In this first part, we will discuss the needle-free PFS and the dual-chamber system.

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Free collection of articles exploring topics including the various types of risks associated with medicinal products, the role of risk management in pharmaceutical and biopharmaceutical regulation, QRM principles and practices, the role of QRM across the product life cycle, primary literature sources for QRM, and common challenges associated with QRM implementation.

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