Validation, Commissioning & Design Featured Articles

81. The Alternative Solution To Comply With The New GMP Annex 1 6/25/2026

    Rising Annex 1 demands are pushing facilities to rethink contamination control. See how RABS retrofits offer a practical path to compliance, combining effective containment and faster implementation.

82. Does The FDA's Plausible Mechanism Pathway Revolutionize The Way All Risks Are Analyzed? 6/23/2026

    The FDA's new guidance on plausible mechanisms represents the first regulatory guidance-driven example of where the primary information source of a risk analysis is shifted from data-based to mechanism-based evidence.

83. cGMP Vs GMP In Cleanrooms: Understanding The Differences That Matter 6/19/2026

    Differentiating GMP from cGMP helps facility teams design cleanrooms that meet modern contamination controls, process flows, and regulatory standards.

84. A Practical Guide To Autologous CAR T Manufacturing 6/19/2026

    Early process decisions shape scalability, consistency, and compliance in autologous CAR T manufacturing. Learn where variability emerges across the workflow and how to plan ahead.

85. The Invaluable Asset Driving Advanced Therapies Forward 6/19/2026

    Cell therapies are advancing rapidly, but manufacturing delays still limit patient access. Improving operational understanding, reducing risk, and strengthening collaboration may be just as critical.

86. A Custom Path To The Clinic: Inside A Collaborative Model 6/19/2026

    Balancing speed, compliance, and control is no small task. A different approach to external support is emerging—one that prioritizes knowledge transfer, collaboration, and long-term confidence.

87. Collaborative Supply Chain Management In A Fragmented World 6/15/2026

    Biopharma supply chains are under pressure. As regionalization accelerates, success depends on agility, trust, and new approaches to collaboration that can withstand ongoing global uncertainty.

88. The Fill/Finish Timeline: What Comes After Manufacturing 6/15/2026

    The post-manufacturing backend of sterile injectable fill-finish operates in a strict sequence—encompassing inspection, testing, QA review, and complex labeling validation—requiring early planning to avoid timeline delays.

89. Rethinking Fill-Finish To Reduce API Loss In Early Development 6/15/2026

    Early-stage drug programs can preserve constrained API supplies by replacing large-scale manufacturing defaults with deliberate, right-sized fill-finish designs that minimize avoidable process waste.

90. Never Miss A Deadline: Why Scheduling Inspector Qualifications Is Imperative 6/12/2026

    Missing a qualification deadline compromises compliance. Discover how centralizing training records and automated scheduling shifts your quality program from a reactive scramble to audit readiness.