Insights On Quality Control

  1. 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.

  2. From Day One Success To Everyday Improvement: The OR → OE Continuum 11/24/2025

    Bridging the gap between initial startup and long-term sustainability requires a unified strategy. Learn to transform early readiness metrics into a durable operating system that drives continuous performance improvements.

  3. 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.

  4. Human Performance In Pharma: Strengthening The Biotech Workforce 11/24/2025

    Transforming the pharma workforce requires strategic partnerships and a shift toward behavioral and operational readiness, moving beyond simple technical training to ensure performance and compliance.

  5. Pave The Way To High Productivity With Continuous Manufacturing For Pharma 12/12/2025

    Continuous manufacturing delivers agility and precision for pharma, combining automation, reduced manual steps, and quality control to meet regulatory and cost pressures while accelerating development.

  6. Regulatory Compliance And Advanced Solutions For Aseptic Environmental Monitoring 1/29/2026

    Modern aseptic monitoring requires a shift from periodic checks to risk-based strategies. Learn how to integrate particle and environmental data to meet Annex 1 standards and ensure patient safety.

  7. ICH Q9 Revision 1: Enhancing Quality Risk Management 8/12/2024

    ICH Q9 Revision 1 advances the framework of Quality Risk Management (QRM) in the pharmaceutical industry, by addressing technological advancements and evolving regulatory expectations.

  8. Contamination Control Of Particulate And Shuttle Blow-Fill-Seal Compliance 2/24/2026

    Does shuttle blow-fill-seal truly meet Annex 1’s stricter contamination standards? New particle burden data challenges industry assumptions and reveals what manufacturers need to know.

  9. A CDMO's Take On Psychedelic Formulation 1/26/2026

    Psychedelics show therapeutic promise, but face major formulation and regulatory hurdles. Advances in delivery and neuroscience may unlock new mental‑health treatments.

  10. 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.