Packaging & Product Protection Featured Articles

  1. Strategies For Developing And Manufacturing Highly Potent Compounds 1/4/2023

    Explore why it is important to classify HPAPIs, how they are evaluated, how HPAPI facilities are qualified, and strategies to ensure containment and safety when handling HPAPIs.

  2. Optimizing Package Integrity Operations For Multiproduct CDMO Facilities 12/5/2022

    How can a CDMO optimize operations in a multiproduct facility while also ensuring their package integrity testing technology can meet the needs of pharma manufacturers and their products?

  3. Frequent Deficiencies In GMP Inspections, Part 1 11/14/2022

    It is sometimes astonishing how often pharmas and biotechs "commit" similar or even the same GMP mistakes — in (almost) always the same places. Here are two of the most common pitfalls to avoid: inadequate handling of deviations and inadequate handling of changes.

  4. Late-Stage Serialization Customization: A Key Differentiator For CDMOs 10/18/2022

    CMOs and CPOs currently face significant challenges, including strong competition, high cost pressure, and more. Learn why being agile, flexible, and responsive is bound to pay off.

  5. Digital Solutions For Combatting Counterfeit Med Devices And Pharmaceuticals 9/29/2022

    Learn how digital solutions and a modern ERP system can effectively combat counterfeit med devices and pharmaceuticals to improve patient safety and business performance.

  6. How CDMOs Can Avoid Package Integrity Recalls Through Sustainable Compliance 9/6/2022

    CDMOs can help drive sustainable compliance for their customers by understanding what questions they should ask to identify the right container closure integrity testing method for their customers’ products.

  7. What CDMOs Should Know About Container Closure Integrity Testing 8/30/2022

    What do CDMOs need to know about container closure integrity testing and the solutions available that will help protect products and drive quality?

  8. FDA Publishes Guidance For Biopharma Container And Carton Label Design 6/13/2022

    The scope of this new FDA guidance includes prescription drug products marketed under an approved NDA or ANDA, prescription drugs marketed without an approved application, and biological products marketed under an approved BLA, but the principles may apply to OTC, compounded, or investigational products.

  9. Factory/Site Acceptance Testing & Commissioning Responsibilities 2/22/2022

    Execution of factory acceptance testing (FAT) and site acceptance testing (SAT) is a business-critical activity when it comes to commissioning of a new system or equipment. FAT is conducted at the equipment manufacturer’s site and SAT is conducted at the final site of installation. This article shares best practices.

  10. FDA Proposes Inspection Of Injectable Products For Visible Particulates 2/1/2022

    FDA and CDER have released a draft guidance addressing the development and implementation of a holistic, risk-based approach to visible particulate control incorporating product development, manufacturing controls, visual inspection, particulate identification, investigation, and corrective actions. The public comment period ends Feb. 15, 2022.