Regulatory Articles

  1. The Benefits of Aqueous Critical Cleaning In Manufacturing

    The use of aqueous cleaning in medical device manufacturing can provide numerous benefits in terms of efficacy, minimal surface contact and reduced residue potential, and easier cleaning validation.

  2. Demystifying Performance Testing: Strategies To Qualify Combination Products

    Explore applicable regulations and guidances, and performance risks identified using failure modes and effects analyses (FMEA) and failure cause mapping analyses.

  3. Addressing Glass Particulates In Injectable Drug Formulations

    Learn how a new vial design that is capable of reducing the propensity for glass particulate generation on filling lines is enabling a significant, positive impact on product quality and safety.

  4. Create An Effective Risk Management Program

    Drug-device combination products are rapidly increasing in use, based on their numerous benefits. This article is a review of achieving performance and regulatory compliance for their successful development and commercialization.

  5. A 15-Minute Guide To Compliant Document Management For Life Sciences

    Life Sciences quality and manufacturing organizations face three critical industry forces:  increasingly stringent regulation; globalization; and virtualization of supply networks.

  6. A 15 Minute Guide To Efficient And Compliant Management Of GMP Controlled Documents

    Life Sciences quality and manufacturing organizations face three critical industry forces: increasingly stringent regulation; globalization; and virtualization of supply networks.

  7. Stainless Steel Needles: Quantifying Cobalt Risk For EU Regulation

    Learn how a partner who is committed to ensuring the safety of medical devices by mitigating the risk of chemical interaction with drugs is crucial for navigating the regulatory pathway to approval.

  8. Container Closure Integrity: A Risk-Based Approach

    Container closure integrity is essential to protecting drug product and satisfying regulatory agencies. A risk-based approach enables creation of a robust data file for timely approval of regulatory applications.