Insights On Quality Control

  1. Mitigating Risks In Sterile Injectable Manufacturing: How CMOs Can Ensure Product Safety 7/23/2025

    Sterile injectable manufacturing carries high risks. CMOs like Afton Scientific use rigorous quality systems, audits, and training to ensure patient safety, compliance, and product integrity.

  2. Method Migration Of A Normal Phase HPLC Method For Tocopherols 9/17/2024

    The ability to migrate methods across HPLC systems is essential as systems are updated. Review a normal phase method that provides a means for quantification of tocopherols in vitamin supplements.

  3. Aseptic Expertise And Delivery Of Services 8/20/2024

    A pharmaceutical services company sought expert intervention after a routine requalification of their aseptic simulation process revealed a contaminated unit, halting commercial production for two months.

  4. Digitalizing Pharma Control Strategies: A Roadmap 1/24/2025

    Digitalizing control strategies in pharmaceutical manufacturing enhances product quality, compliance, and efficiency, leveraging data-driven approaches like QbD, and digital CPV for optimized processes.

  5. Accelerate Biologics Product Release With Seamless Viral Testing 6/23/2025

    Explore viral safety testing for biologics, focusing on prevention, detection, and removal strategies, updated regulatory guidance, and common challenges in unprocessed bulk testing.

  6. How To Achieve Right-First-Time Manufacturing 1/21/2026

    Modernizing QC requires more than isolated fixes. Discover how cloud-based platforms unify systems, automate workflows, and improve data access to help labs reduce cycle times and minimize rework.

  7. Quality By Design In The Pharmaceutical Industry 12/12/2025

    Real-time release and digital quality management, powered by PAT, are driving efficiency and compliance, reshaping how manufacturers achieve speed, consistency, and competitive advantage.

  8. Aggregate Analysis Of Tirzepatide 12/11/2025

    A new size exclusion method effectively analyzes Tirzepatide aggregates, demonstrating robust separation and reproducibility with minimal need for organic solvents or acidic modifiers.

  9. Digitizing Quality Management: The Key To Avoiding FDA Recalls In Life Sciences 1/13/2025

    Explore the need for digital quality management systems to ensure compliance as life science companies face rising FDA recalls.

  10. Navigating The Analytical Complexity Of Oligonucleotide Therapeutics 9/13/2024

    From identity and purity testing using chromatography and electrophoresis to PCR and microbial studies, explore advanced analytical solutions tailored for siRNA, miRNA, pDNA, and mRNA products.