Packaging & Product Protection Featured Articles
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Data Quality Issues At The Heart Of FDA's DSCSA Troubles
10/18/2024
Industry still struggles to manage complex data requirements, which forced the FDA to once again delay enforcement of the Drug Supply Chain Security Act.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.