Industry Insights

81. Where Contamination Control Really Breaks Down In Practice 3/13/2026

    Contamination control gaps arise when two dynamics merge — when processes become familiar and workloads increase. Here's how to spot them before they spin out of control.

82. Is Lipinski's Rule Of Five Still Relevant In Drug Development? 11/13/2024

    Some drugs violate multiple Ro5 elements but remain developable, while some molecules adhere strictly to the Ro5, but their properties are not conducive to development.

83. India's New Drugs, Medical Devices, And Cosmetics Draft Bill 2022 11/7/2022

    To accommodate changing requirements and encourage the adoption of new technology, India’s Ministry of Health and Family Welfare released a draft bill in July 2022 to replace the existing Drugs and Cosmetics Act 1940. What are the major areas of change and how much of an impact will there be?

84. Leveraging Communal Goals To Build A Sustainable Future For Pharma Manufacturing 10/9/2024

    Rethinking your company’s SOPs to reduce carbon emissions and ensure more sustainable workflows is no easy feat. The key is looking at these initiatives as a crucial, community-driven effort.

85. Insulin's 100-Year History Inspires Today's Biotech Industry 2/22/2023

    Former FDA regulator Jeffrey C. Baker, Ph.D., has been speaking on the history of insulin, the first biologic, at seminars and conferences for years. This year, those talks seem more important as we mark the 100th anniversary of this life-saving drug. Baker says insulin's story holds inspiration for today's biotech companies.

86. 5 Key Considerations For MES Vendor Selection 10/20/2023

    Have you made a strategic business decision to implement a manufacturing execution system (MES)? Selecting a MES vendor is a strategic and thoughtful process. With these five considerations, you can give some thought to how MES fits into your enterprise landscape and your business requirements.

87. How Can We Use The UDI To Improve The Device Recall Process? 1/7/2022

    The Unique Device Identifier (UDI) was expected to improve patient and medical device safety by enhancing key patient safety systems like the product recall and adverse event reporting processes and improving device evaluation. AHRMM recently completed a survey of various stakeholders; this article delves into the survey's findings and the recommendations for improving the device recall process.

88. How Is The Market Responding To Brisk HPAPI Demand? 3/17/2025

    The rise of precision medicine like ADCs has created new markets for highly potent API. More suppliers are building out capacity to meet the demand.

89. Process Mapping For More Effective Knowledge Management 2/26/2024

    It takes a patchwork of knowledge from multiple complementary mapping tools to generate the process knowledge needed for success in pharmaceutical and biologics manufacturing.

90. What To Expect From A Remote Inspection -- & How To Navigate It 7/23/2021

    Regulators have moved toward remote inspections since the pandemic began, and this is likely to continue. This article presents an overview of the remote inspection process and provides advice on how to prepare for and deal with the inspection on the day, as well as how to respond to any concerns raised following the audit.