Quality Featured Articles

  1. A Closer Look At Inspection Systems In Tablet And Capsule Production 8/29/2024

    Walk through the rigorous inspection process pharmaceutical products undergo to ensure safety and quality, from granulated ingredients to packaging.

  2. Guide To Product Inspection Systems In The Pharmaceutical Industry 8/29/2024

    Explore the critical role of inspection systems, specifically metal detectors, X-ray systems, and checkweighers, in pharmaceutical manufacturing.

  3. A Guide To Vision Inspection Systems For Drug Manufacturers And CDMOs 8/22/2024

    Gain insight into the role of vision inspection technologies in ensuring the quality of primary packaging in pharmaceutical manufacturing, common misconceptions when evaluating these systems, and more.

  4. Increasing Quality And Reducing Costs With AI-Powered Inspection 8/1/2024

    AI-supported inspection processes offer a future-proof solution to the challenges of vision inspection. Learn how to get started with AI-supported inspection.

  5. 2023–2024 Trends In FDA Form 483s For Pharmaceutical Formulation Facilities 8/1/2024

    A comprehensive review of FDA observations from small molecule drug facilities sheds light on the state of compliance and regulatory practices in the pharma industry.

  6. FDA Finalizes Guidance About Delaying, Denying, Limiting, Or Refusing An Inspection 7/25/2024

    The FDA has finalized a guidance on the circumstances that constitute delaying, denying, limiting, or refusing a drug or device inspection. The agency also provides reasons that may cause drugs or devices to be adulterated under the FD&C Act.

  7. A Practical Packaging Components Checklist For Emerging Biotechs 6/20/2024

    A proactive approach to packaging development can ultimately ensure a smoother launch. Explore five key considerations when selecting components for your injectable drug product.

  8. Understanding Injectable Drug Container Closure Systems 6/20/2024

    Choosing the right container closure system (CCS) format is crucial, so understanding the different parts involved, their functions, storage requirements, and how they impact administering the drug is essential.

  9. Achieving Ophthalmic Production 5/23/2024

    A partner with state-of-the-art facilities can guarantee efficient and scalable production of ophthalmic solutions, drops, and ointments, and is critical as you navigate the complexities of ophthalmic production.

  10. Trends In FDA FY2023 Inspection-Based Warning Letters 2/13/2024

    The U.S. FDA issued 180 warning letters to drug and biologics manufacturers in fiscal year 2023 (FY23) and 94 of them were based on an on-site inspection of the company. This article provides an analysis of trends and observations from the inspection-based letters, as well as additional insight on the agency’s approach to enforcement.