Featured Articles

1. 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.

2. 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.

3. 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.

4. 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.

5. 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.

6. 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.

7. Improve Speed To Market By Mitigating Vial And Stopper Incompatibility 10/1/2024

   These studies indicate that with a properly assembled vial containment system, good CCI performance can be achieved with stoppers of a given elastomer, independent of configuration/size, or vial style.

8. Design Verification Testing Of Combination Products 7/12/2024

   Developing a combination product and seeking a list of tests to complete design verification testing? Review the details for planning, design inputs, design outputs, and design verification.

9. How Recent Trends Impact Bringing Your Molecule To Market 7/9/2024

   With accelerated approval times, growing competition between drugs, and a shift from hospital to home care, you’re under pressure to develop a delivery device in parallel with your drug.

10. 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.