Editorial

  1. Minimizing The Impact Of Human Errors Using Relational Risk Analysis 8/4/2025

    This article describes how a mechanism-based risk analysis approach can provide two complementary opportunities for minimizing the likelihood of a human error impacting pharmaceutical and medical device risks.

  2. Trends And Benefits Of Lean Manufacturing In Pharmaceutical Injectable Facilities 8/4/2025

    The pharmaceutical injectable manufacturing sector is experiencing unprecedented transformation through lean manufacturing adoption. This analysis examines current implementation trends, productivity impacts, and quality integration strategies based on data from leading pharmaceutical organizations.

  3. The Building Blocks Of A Robust Analytical Assay 8/1/2025

    Analytical assays aren't just important for quality control. Regulators expect them. These tips will help if you're just starting to build your analytical package.

  4. Environmental Monitoring Performance Qualification In New Drug Manufacturing Facilities 8/1/2025

    In setting up a new manufacturing facility, a robust process for environmental monitoring must be established and cleanrooms in the classified areas must be properly qualified. Here are critical considerations to keep in mind.

  5. AI Data Security: The 83% Compliance Gap Facing Pharmaceutical Companies 7/23/2025

    A new study reveals a shocking truth: only 17% of pharmaceutical companies — including many CDMOs — have implemented automated controls to prevent sensitive data from leaking through AI tools.

  6. Here's What Limits AI's Outlook For Replacing Knowledge Workers 7/21/2025

    Even after AI developers clean up hallucinations and other short-term issues, a large-scale workforce replacement faces a few intractable obstacles.

  7. How Much Knowledge Work Can Biopharma Offload To AI? Answer: Not Much 7/21/2025

    In biomanufacturing, knowledge work and manual work are deeply intertwined. One expert suggests replacing entire workflows with artificial intelligence seems unlikely.

  8. Preparing For FDA's Expanded Use Of Unannounced Inspections At Foreign Manufacturing Facilities 7/10/2025

    The FDA announced on May 6, 2025, that it intends to expand its use of unannounced inspections at foreign manufacturing facilities. Here are key considerations and actions to take in order to be prepared.

  9. Pharma Enterprise Resource Planning: From Automation To AI-Driven Insights 7/10/2025

    Pharmaceutical firms are increasingly turning to enterprise resource planning (ERP) systems to modernize operations. These platforms unify core functions, including supply chain management, manufacturing, and financial planning and analysis.

  10. Managing Extractables And Leachables In HPAPI Manufacturing 7/10/2025

    These contaminants can compromise the quality, stability, and safety of a drug product, and regulatory bodies mandate assessment to protect patients.