Episode Summary: In this episode of Measuring Up: Thinking Out Loud, host Bill White sits down with Sean Merrill, a Validation Engineer at Testo with over 11 years of experience in commissioning, qualification, and validation. They explore the critical history of the regulatory landscape and how modern risk-based approaches are streamlining safety protocols in the pharmaceutical and industrial sectors.

The conversation traces the reason behind modern regulations to contextualize the current integrated approach that prioritizes innovation and efficiency. Sean explains how companies can leverage documentation and third-party expertise to turn validation from a necessary evil into a value-added asset for patient safety and product quality.

About the Guest: Sean Merrill is a Validation Engineer at Testo. With more than a decade of experience in commissioning, qualification, and validation, he specializes in helping organizations navigate complex regulatory environments and operational nuances. Sean is an expert in implementing risk-based strategies for pharmaceutical manufacturing, logistics, and distribution centers, ensuring that facilities and equipment consistently meet the highest standards for their intended use.

Key Points:

• Defining CQV: A breakdown of Commissioning, Qualification, and Validation, and how these distinct processes work together to ensure a facility is suitable for its intended use.
• The Catalyst for Regulation: How historical tragedies—including the 1950s Cutter incident involving the polio vaccine and the thalidomide morning sickness remedy—led to the first FDA GMP regulations in the 1960s.
• From Overkill to Risk-Based Logic: The evolution from the 1980s "validate everything that moves" mindset to modern, integrated methods that prioritize innovation and value.
• Leveraging Documentation: How integrating commissioning and qualification allows organizations to use well-documented supplier testing to satisfy regulatory requirements without redundant effort.
• Industry Standards: An overview of essential guidance used in the field, including ISPE’s Baseline Guide 5 and ASTM E 2500.
• Testo’s Consultative Approach: How Testo serves as an objective third party, offering a buffet of services from drafting validation master plans to conducting specialized temperature mapping.

Resources:

• https://www.testo.com/en-US/solutions/pharmaceutical-validation-qualification
• https://www.testo.com/en-US/services/validation-and-mapping-services
• https://www.testo.com/en-US/solutions/pharma-solutions