Featured Articles

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   All future submissions are expected to align with FDA's draft guidance that clarifies the agency's expectations for establishing, evaluating, and controlling Essential Drug Delivery Output (EDDO) requirements.

2. 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.

3. Fixtures And Surrogates For Combination Product Performance Testing 5/16/2025

   The combination product market is consistently expanding. Transitioning from traditional vial systems to needle-based combination products presents several challenges that require careful consideration.

4. Leachables Method Development, Validation And Relevant ICH References 5/16/2025

   It is crucial to develop and validate analytical methods capable of detecting a wide range of potential organic and inorganic leachables specific to the drug and its packaging.

5. FAQs On The Revised EU GMP Annex 1: Volume 2 3/5/2025

   Review the implementation of a holistic Contamination Control Strategy (CCS). Discover four key considerations for assessing component readiness: product, process, protection, and proof.

6. FAQs On The Revised EU GMP Annex 1: Volume 1 3/5/2025

   The revised GMP Annex 1 guidelines emphasize quality risk management, enhanced environmental monitoring, and data integrity, which aim to minimize contamination and ensure patient safety.

7. Meeting Annex 1: A Proactive Approach To Regulatory Compliance 3/4/2025

   It was imperative for a large European CMO that produces multiple biologic drugs to select the right product quality and value for each customer to comply with the August 2023 revision to the EU GMP Annex 1.

8. Achieving EU GMP Annex 1 Compliance For Contamination Control 3/4/2025

   Gain insight into three areas that have been key in ensuring a robust contamination control strategy to help ensure compliance with the updated Annex 1 regulation: planning, people, and products.

9. A Robust Extractables Data Package Helps Drive Patient Safety 10/1/2024

   Complex drug product formulations are more common, so it is imperative to have a deeper knowledge of extractables to understand risks associated with potential interactions between packaging and product.

10. Vial Containment Systems Based On Elastomer 4031/45 Gray 10/1/2024

    Examine the results of two, two-year studies that indicate good container closure integrity performance that can be achieved with stoppers of a given elastomer, independent of configuration.