Insights On Quality Control

  1. 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.

  2. Innovative Technology For Developing, Scaling Peptide-Based Therapeutics 11/18/2024

    Watch as experts walk through several technologies and case studies, focusing on liquid-phase peptide synthesis, crystallization, method development for impurity analysis, and more.

  3. Software Simplifies 21 CFR Part 11 and Annex 11 Compliance 12/9/2024

    21 CFR Part 11 and Annex 11 regulate electronic records and signatures in biomanufacturing, ensuring data integrity, security, and compliance while enabling efficient processes and regulatory alignment.

  4. Thermal Analysis In The Pharmaceutical Industry 12/30/2024

    Thermal analysis techniques provide valuable insights into pharmaceutical material properties, ensuring compatibility, stability, and quality control in drug development and production processes.

  5. 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.

  6. Tackling Residual DNA Testing In Biotherapy Manufacturing 7/16/2025

    Controlling residual host cell DNA is critical for the safety and efficacy of biotherapeutics. Learn about robust, highly sensitive analytical methods for effective DNA clearance and process control.

  7. Building Control Strategies: It's Time To Go Digital 1/24/2025

    Digital control strategies in pharma enhance product quality, regulatory compliance, and efficiency by leveraging real-time monitoring, automated documentation, and Quality by Design (QbD) frameworks.

  8. Essential Insights Into Pharmaceutical Product Release: Part 2 1/13/2025

    Optimizing pharmaceutical product release requires effective planning, specification development, electronic systems, and collaboration with CMOs, ensuring compliance, efficiency, and quality in the drug manufacturing process.

  9. Pharma Custom Isolator For Sterile Lab Process 6/19/2024

    This project showcases Germfree’s capacity to provide cutting-edge, bespoke solutions in pharmaceutical manufacturing, underpinning their dedication to innovation, safety, and quality.

  10. Comparative Study On Secondary Contamination Risk 1/31/2024

    Accurate testing results are crucial for product safety. Explore the findings of a comparative study evaluating two different platforms for the membrane filtration of microorganisms in quality control.