Articles by Irwin Hirsh

  1. The Promise And Paradox Of QbD 11/24/2025

    The difference between QbD as burden and QbD as advantage lies in critical thinking supported by structure — a hierarchy of metrics, toolsets, and tailored platforms.

  2. A Hierarchy Of Metrics Brings Strategy Into Biopharma's Daily Work 11/21/2025

    Information now flows faster than organizations can think about it, and without deliberate structure, decision-making becomes reactive rather than reflective.

  3. A Case Study In Continuous Process Verification 9/8/2025

    CPV can strengthen the bridge between compliance and continuous improvement. In this scenario, a hypothetical lab sets out to improve process yields and efficiency.

  4. Lean Thinking For Pharma — Flow Without Facility Upheaval 4/28/2025

    Lean offers manufacturers a host of efficiencies, but they don't all work for GMP. Here are some ideas for translating best practices for a highly-regulated industry.

  5. Embracing An Economic Model For Agile Process Development 11/27/2024

    If AI-led discovery brings the surge in new candidates it promises, will process teams be ready?

  6. Team Topologies For Outsourced CMC Development 9/27/2024

    When functions such as analytics or formulation get outsourced, team dynamics must adapt to ensure cohesive integration and effective communication.

  7. Accelerate CMC Development With Team Topologies 9/20/2024

    A method of defining role boundaries for knowledge workers in the IT industry maps nicely to CMC process development for biologics and pharmaceutical manufacturing.

  8. Why Knowledge Workers Must Embrace Standard Work 7/10/2024

    Highly educated scientists often resist the notion of standard work because it seems stifling. On the contrary, standard work can increase productivity and creativity.

  9. Improving Governance And Compliance With Knowledge Management 4/23/2024

    Knowledge management — it’s not just a soulless exercise. In the last part of his series, Hirsh helps bridge the gap between compliance and business needs.

  10. Digitizing CMC Knowledge Management 4/8/2024

    Systems that enhance know-how retention stretch from utterly simple to enterprise-scale. Here are some ideas for incorporating them into your knowledge management strategy.