Industry Insights

71. The Ideal Quality Management System For Packaging And Printing 10/29/2018

    Quality management systems come in many shapes and sizes. Each is largely dependent on the industry to which a given application caters. There are nevertheless basic standards that must be met.

72. How You Should Prepare For Foreign FDA Inspections

    Ensure you understand the expectations of regulators and what you can do to facilitate successful paper-based inspections in lieu of those performed on-site.

73. Developing A Comprehensive Regulatory Approach For LNP Drugs 2/26/2024

    The path to regulatory approval for LNPs demands carefully considered strategies. By adopting proactive and strategic approaches, developers can overcome regulatory hurdles on the path to approval.

74. Optimize Manufacturing Using Comprehensive Powder Characterization 11/25/2019

    Understanding the range of powder behavior characteristics through measurement of the most appropriate properties is essential for efficient processing and consistently high-quality finished products.

75. These Are The Top Priorities & Challenges For New CDER Director Patrizia Cavazzoni, M.D. 7/30/2021

    Recently appointed to the permanent CDER director role, Dr. Cavazzoni’s appointment was not unexpected, as she was recruited to join the FDA in 2018 from a senior industry role and served as acting CDER director at the start of the agency’s pandemic response. Her experience suggests she will continue to evolve – rather than revolutionize – FDA’s drug review policies.

76. Dealing with Packaging Complexity: Tips 13 to 16 12/17/2014

    By Stephen McIndoe, VP Consulting, Be4ward

    In my previous articles, I discussed a series of tips on managing packaging complexity. In this article, I will examine the next four tips, which continue on the theme of how to cope with added-value complexity.

77. New DSCSA Compliance Blueprint Includes FDA & Industry Input 4/12/2023

    Pharmaceutical manufacturers, distributors, and pharmacies must all ensure they are ready for the Drug Supply Chain Security Act (DSCSA)'s full implementation starting on Nov. 27, 2023. The Partnership for DSCSA Governance, a public-private partnership, has published a blueprint compiling input from every sector, including FDA, industry, and solution providers.

78. A Practical Guide To Navigate The EU's Revised GMP Annex 1 9/9/2022

    The EU's final version of the GMP Annex 1 is now published, and it's time to take action. This article shares a road map to navigate what is new and different, how to document your "known unknowns," and more. Quality risk management and a contamination control strategy will be key.

79. How Can Contract Organizations Bridge The Talent Gap In Biopharma? 4/7/2022

    Instrument vendors can play a critical role in decreasing the training timeline for new and even existing staff at a contract organization.

80. 10 Practical Tips For GMP Cleanroom Contamination Monitoring 2/13/2026

    A robust cleanroom monitoring program is your best defense against contamination. Align your strategy with Annex 1 to detect risks early, protect your product, and ensure patient safety.