Featured Articles

1. FAQs On The Revised EU GMP Annex 1: Volume 6 9/21/2025

   The revised EU GMP Annex 1 prioritizes a CCS. Learn how to holistically manage microbial, particulate, chemical, and cross-contamination risks to ensure product sterility and patient safety.

2. Taking A Best Practice Approach To Contamination Control  9/21/2025

   Implementing the EU GMP Annex 1 requires a holistic, evolutionary Contamination Control Strategy built on standardization, data analytics, and continuous improvement for a zero-defect mindset.

3. Laying Supply Chain Foundations That Bring Confidence To Compliance 9/21/2025

   Compliance with EU GMP Annex 1 requires a strategic CCS. Learn how a framework based on people, communication, process, and continuous improvement enables systematic, long-term compliance.

4. FAQs On The Revised EU GMP Annex 1: Volume 3 9/21/2025

   The EU GMP Annex 1 revision, effective August 2023, requires a detailed Contamination Control Strategy. Learn how it impacts global manufacturers, RABS use, and personnel procedures.

5. Vial Adapter Transfer Device Compatibility With Cell Therapies 7/25/2025

   Needles and syringes are commonly used to retrieve cell therapies from vials, posing the risk of needle stick injury. Explore the suitability of needle-free polycarbonate transfer devices.

6. Safely Navigating The Transition From MDD To MDR 7/25/2025

   If devices are integral to positive patient outcomes, device partners must play an integral role to ensure regulatory compliance is achieved in the most effective way.

7. De-Risking The Transition From Vial To Drug-Device Combination Product 7/25/2025

   When transitioning from a vial to a combination product system, the best approach is to have a holistic de-risk strategy with an intentional focus on the patient, the plan, and the product.

8. Low Temperature Storage Containment For Vial And Syringe Systems 6/20/2025

   With the growth of advanced therapy medicinal products, there is an increased need for specialized low-temperature packaging solutions, particularly for vials and syringe systems at -50°C to ≤ -130°C.

9. Essential Drug Delivery Outputs For Devices To Deliver Drugs, Biologics 5/16/2025

   All future submissions are expected to align with FDA's draft guidance that clarifies the agency's expectations for establishing, evaluating, and controlling Essential Drug Delivery Output (EDDO) requirements.

10. Sample Sizes For Performance Testing Of Combination Products, Packaging 5/16/2025

    When developing combination products or evaluating primary packaging for drug products one must evaluate the performance of the devices and the packaging to ensure that they are fit-for-purpose.