Packaging & Product Protection Featured Articles

  1. 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.

  2. Should You Be Using Unique Container Identification? 8/22/2024

    Unique identifiers on glass vials could solve a host of problems. ISPE developed a new guide to help manufacturers apply them on primary parenteral containers.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. Addressing Challenges In Serialization For Complex Therapeutics 5/7/2024

    The magnitude of serialization, especially for firms with extensive portfolios and intricate supply chains, poses serious challenges. This discussion offers solutions.

  9. Are You Missing An Important Stage In Raw Material Product Inspection? 4/23/2024

    Learn why product inspection is crucial in ensuring safety and quality control for food manufacturers.

  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.