Insights On Regulatory Compliance

  1. ISO/DTR 14644 -21 Cleanrooms And Associated Controlled Environments 2/22/2024

    Here, we review the Technical Report outlining how particle counters are used to classify and monitor cleanroom performance, ensuring it meets required standards under normal operating conditions.

  2. Leachables Method Development, Validation And Relevant ICH References 5/16/2025

    It is crucial to develop and validate analytical methods capable of detecting a wide range of potential organic and inorganic leachables specific to the drug and its packaging.

  3. Digital Transformation In Contract Manufacturing: A Leadership Perspective 5/13/2025

    Discover how PCI Pharma Services embraced digital transformation and gain expert insight on overcoming challenges, driving innovation, and maintaining core values in a regulated industry.

  4. Compliance Audits: 4 Solutions To Avoid Failure 9/20/2024

    Although inspection and audit processes have evolved, you can still effectively navigate and manage them within your organization. Explore four solutions to address audit and inspection pain points.

  5. White Raven's Accelerated Path To GMP Certification 4/28/2025

    CDMO White Raven achieved GMP certification using an innovative aseptic filling solution in just 18 months. Discover how meticulous planning and collaboration set a new industry standard for efficiency.

  6. Building An Effective Contamination Control Strategy For Final Sterile Filtration 8/13/2024

    Watch to learn about important considerations for final sterile filtration throughout product development and for performing pre-use post-sterilization integrity testing.

  7. Downstream Strategies To Accelerate Preclinical Development Timelines 4/3/2024

    As recombinant protein-based products accelerate toward IND, reliable process development methods are critical to meet demand. Review case studies to learn how expedited timelines can be achieved.

  8. Accelerate Production Through Digital Commissioning And Qualification 12/17/2024

    Watch to learn how digital validation streamlines commissioning and qualification (C&Q), improving productivity, compliance, and cost-efficiency across your organization.

  9. Biomanufacturing Operator Training And Solutions 5/20/2025

    Discover a hands-on biomanufacturing training program that empowers operators with essential skills, boosts efficiency, and supports innovation in the fast-paced biopharma industry.

  10. Biofluorescent Particle Counters Are Gaining Momentum 4/28/2025

    The 2025 BioPhorum report highlights challenges and trends in drug filling operations and how they are advancing towards biofluorescent particle counters. Discover an approach that aligns with industry needs.