Validation, Commissioning & Design Featured Articles

  1. ICH M4Q(R2) And M16 Modernize The CTD For Digital Submissions 9/28/2026

    A former FDA assessor explains how recent changes to the common technical document bring long-overdue updates to the submission process, accounting for greater data demands.

  2. Beyond Compliance: What Defines Quality Excellence In A CDMO 9/25/2026

    Strong quality programs are built on more than audits. Explore how culture, systems, and continuous improvement support reliable manufacturing outcomes.

  3. How Does SUS Integrity Change Across The Drug Product Lifecycle? 9/24/2026

    Learn how phase-appropriate risk justification, validation, documentation, and lifecycle controls can strengthen sterility assurance while reducing the potential for rework and delays.

  4. Overview Of Single-Use System Integrity Assurance 9/24/2026

    Single-use system integrity depends on managing risk across the entire life cycle. Explore how materials, packaging, transport, installation, handling, and use influence sterility assurance.

  5. Increasing The Sustainability Of API Production 9/24/2026

    From green chemistry to digital tools, see how process optimization is helping pharmaceutical manufacturers meet sustainability goals and improve operations.

  6. Enhancing The Sustainability Of API Production Through Distillation 9/24/2026

    Resource recovery and waste reduction are reshaping API manufacturing. Learn how optimized distillation can support both sustainability and operational performance.

  7. Tackling The Key Challenges In Viral Vector Manufacturing 9/23/2026

    How can cell and gene therapy developers scale viral vector production while maintaining quality? Explore strategies that support productivity, purity, and process control.

  8. What To Look For In A Fill & Finish Partner 9/23/2026

    How do you evaluate a fill-and-finish partner with confidence? Discover the capabilities that help ensure product integrity, compliance, and scalable manufacturing success.

  9. Quality Engineered: The Power Of QbD 9/23/2026

    How can manufacturers improve process control and flexibility? Explore the benefits of combining QbD with mechanistic modeling.

  10. Accelerate Drug Development With Phase-Appropriate Thinking 9/23/2026

    Successful drug development requires more than a one-size-fits-all approach. Explore strategies tailored to each stage of the journey.