Regulatory

  1. Survival Kit For Quality Regulations: A Closer Look At Lyo Packaging

    Explore primary packaging developed following well-established ICH principles for sustainable compliance and vial container closure systems for product development and commercial manufacturing needs.

  2. Your Contract Manufacturer Partner 12/14/2020

    Discover an integrated solution for pharmaceutical companies that offers a broad range of manufacturing services and capabilities to produce high-quality devices.

  3. Human Factors Testing: Engaging End-Users In Med Device Development 3/11/2025

    Explore the significance of human factors in the development of medical devices through an illustration of how important it is to incorporate the end users in the device development process.

  4. A Practical Road Map For Compliance To EU GMP Annex 1

    Learn how to interpret the Annex 1 container closure requirements, develop deterministic analytical methods for CCIT, and design packaging studies that generate robust data demonstrating good CCI.

  5. Impact Of Water Activity On OSD Product Potency, Purity, And Bioavailability 11/21/2022

    Explore laser-based headspace analysis, the impact of USP<922> Water Activity on primary packing selection, and the impact of water activity on the potency, purity, and bioavailability of OSD products.

  6. Bioburden And EU GMP Annex 1: Risk Assessment, Reduction, And Testing

    Experts on regulation, filtration, sampling, and quality control discuss risk assessment and filtration-based strategies to reduce bioburden.

  7. How Crucial Is Culture Media Selection In Environmental Monitoring? 6/20/2023

    Explore culture media regulatory requirements, the impact of manufacturing guidelines and media features and specifications on environmental monitoring, and the importance of media supplier selection.

  8. Importance Of Architectural Layout To Prevent Contamination 8/21/2025

    In this segment from the Pharmaceutical Online Live event, “Contamination Control Strategies For Drug Manufacturers,” panelists discuss the importance of unidirectional flow for preventing contamination, as well as specific architectural requirements related to the European Union's Annex 1 regulations. Poor or aging facility design is not an acceptable excuse for noncompliance.

  9. Simplifying Bioprocess Data Collection 2/17/2023

    Centralized bioprocess data collection and aggregation lowers the risk of data loss during any manual retrieval process. Discover a solution that helps you meet data storage and reporting requirements.

  10. The Container Closure Integrity Requirements In The Revised EU Annex 1

    Learn about the advantages and disadvantages of CCI testing methods, how the revised EU Annex 1 may impact your strategy for ensuring CCI of sterile pharmaceutical products, and more.