Packaging & Product Protection Featured Articles

  1. 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.

  2. 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.

  3. 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.

  4. 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?

  5. 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.

  6. 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.

  7. 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    FDA and CDER have released a draft guidance addressing the development and implementation of a holistic, risk-based approach to visible particulate control incorporating product development,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.

  8. EPCIS Implementation: 4 Takeaways, Next Steps For DSCSA Compliance 12/28/2021

    With the Nov. 27, 2023, DSCSA deadline quickly approaching, the HDA Research Foundation recently released a survey to assess how the industry is preparing. This article summarizes the 4 key takeaways as well as your next steps for DSCSA compliance.

  9. 9 Pitfalls To Avoid In Data Integrity in Pharmaceutical and Device Development & Operations 9/22/2021

    The first article in this series examined 5 common misconceptions in data integrity (DI). In this article, the author now shares 9 example areas where he has seen significant DI implementation problems in pharmaceutical and medical device companies.

  10. 5 Misconceptions About Data Integrity In Pharmaceutical And Device Development & Operations 9/15/2021

    Data integrity (DI) issues in pharma and medical devices have always been there, but in my experience as a consultant, these issues have increased in frequency more recently, thus moving them to the forefront. In this article, I explain five misconceptions about data integrity in our industry.