Industry Perspectives

  1. New ISPE Framework Targets Uncertainty In Pharma's AI Deployment 1/29/2026

    International Society for Pharmaceutical Engineering members developed the guide to offer a risk-based framework for evaluating, implementing, and maintaining AI systems.

  2. The 5-Layer Fix For AI Failure In Pharmaceutical Manufacturing 1/21/2026

    The promise of AI is colliding with the harsh reality of data chaos in pharma manufacturing. This article explores why most AI investments fail, and a 5-layer solution.

  3. Why Use Total Organic Carbon Analysis For Cleaning Validation? 1/21/2026

    Total organic carbon analysis is probably the most “fit for use” analytical method to validate cleaning processes, particularly within a science- and risk-based approach.

  4. Risk-Based Analytical Method Selection In Cleaning Validation Using ASTM International Standards 10/14/2025

    This in-depth article describes risk in cleaning and provides a science- and risk-based framework for selecting analytical methods using ASTM International standards.

  5. Trust But Verify: Validating AI In Pharma's GxP World 10/3/2025

    Here are practical tips to build validated, transparent, and auditable AI systems that align with GxP principles, paving the way for smarter and more resilient manufacturing processes.

  6. Considerations For Rapid Prototyping In Medical Device Development 9/15/2025

    Rapid prototyping has taken the medical device industry by storm, but there are pros and cons that device developers need to consider.

  7. Audit Trail Compliance And What To Look For In Mitigation Software 7/9/2025

    In the pharma/biotech and medical device industries, the audit trail is important to have for accountability, data integrity, repeatability to create an event for investigation, and regulatory compliance.

  8. Cleaning Process Capability: Risk-Based Cleaning Process Performance Qualification 7/1/2025

    A cleaning validation professional must know how many process performance qualification runs are necessary. Here's how to go about demonstrating this with a high degree of assurance while minimizing the number of qualification runs.

  9. What To Expect When You Move Into Production For The First Time 6/17/2025

    In medical device development, things don’t go quite as you planned the first time around. This article shares what to really expect when you take your device into manufacturing.

  10. Cleaning Process Capability: Understanding Populations, Samples, And Sample Size Requirements 6/6/2025

    This article examines the role of sample sizes in the determination of cleaning process capability or process performance in the manufacture of drugs/therapies and medical devices.