Contributing Editors

  1. FDA Report Details FY24 Inspections, Shows Big Uptick In Key Countries 8/29/2025

    The 2024 Report on the State of Pharmaceutical Quality shows the agency's efforts to normalize post-pandemic oversight under the previous administration.

  2. New FDA White Paper Ties Quality To Financial Benefits 8/26/2025

    The agency presents as a stepwise approach in which companies can make incremental investments rather than committing large amounts of capital upfront.

  3. Avoiding Alcohol-Induced Dose Dumping In Oral Drug Formulation 8/21/2025

    The FDA has become more vigilant about alcohol-induced dose dumping in extended-release oral dosages. Such dumping can result in anything from reduced therapeutic effects to dangerous toxicity. Let's take a closer look.

  4. How AI Is Revolutionizing Quality Management Systems 8/13/2025

    The real question isn't whether pharmaceutical companies should adopt AI in their quality systems, but how to implement it effectively and what specific benefits to expect.

  5. Lean Manufacturing Implementation In Pharmaceutical Injectable Facilities 8/12/2025

    This comprehensive analysis examines lean manufacturing implementation challenges and evidence-based solutions derived from leading pharmaceutical organizations. 

  6. July 2025 — CDMO Opportunities And Threats Report 8/11/2025

    Each month, Outsourced Pharma works in conjunction with PharmSource, part of GlobalData, to present its “Contract Manufacturing: Opportunities and Threats (CMOT) Report” to our readers. The report identifies CDMOs that might be impacted by key events affecting their clients, including company acquisitions, product acquisitions and licenses, product approvals, late clinical product terminations, and FDA rejections.

  7. EMA Issues Revised Annex 11, New Annex 22, And Associated Documents On Data Governance 8/6/2025

    The EMA issued three new draft documents in July, all related to the advancement of the use of electronic technology in GMP: AI, computerized systems, and documentation. The public comment period ends Oct. 7.

  8. 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.

  9. 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.

  10. 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.