When I founded Commissioning Agents in 1996, the practice of “validation” was a paperwork exercise that was ineffective at assuring equipment worked to meet stakeholder expectations. Cost control, budget control, and scope control were rarely applied with project management discipline. IQ/OQ/PQ added months if not 1-2 years to project schedules. Reflecting on my prior Navy submarine experience, I found it amazing that we could test every instrument, every control function, every alarm, indication and interlock on a nuclear reactor in 8-16 hours, documented with the same rigor as GMP requirements, yet testing an automated bioreactor, far less sophisticated, could take weeks.
Both regulators and industry drove change. Industry drove change with the ISPE C&Q baseline guide. Regulators sparked the creation of ASTM E2500, and more importantly the development of ICH Q8/9/10 and beyond, which now form the basis of a science and risk-based approach to the design, delivery and validation of plant and equipment. Industry understands the importance of process and contamination control strategies as fundamental to physical, functional and operational designs.
It is satisfying to know that the good engineering practices we helped industry adopt, coupled with the discipline of project execution, resulted in many large capital projects delivered on or ahead of schedule. These complex projects made life enhancing and sometimes life-saving medicines available to more patients across the globe. We made our customers successful, which made us successful. At the same time, it has been personally satisfying to have given our employees the opportunity to truly make a positive impact on patients and society as a whole. And to allow them to thrive professionally and financially for themselves and their families.
There remain huge opportunities for significant cost and schedule reduction in the delivery of qualified equipment – through better standardization, through the use of digital twins and other technologies to automate the testing and documentation thereof. There remain significant project-to-project differences in delivery planning and execution discipline, with associated differences in cost, schedule and performance results. The idea of a holistic approach to operational readiness is embraced by some, but not all project and site teams.
As science advances, the spectrum of therapies to be manufactured is vast. Volumes range from a single patient-specific lot, to manufacturing networks of multi-billion-dollar facilities delivered as integrated projects across the globe. Industry has come far these past 30 years, answering the challenge to use product and process knowledge and quality risk management in the design and delivery of GMP regulated facilities. Huge opportunities remain in the delivery of manufacturing capacity, to allow industry to deliver new medicines to patients across the globe faster. Humankind deserves affordable, available and high-quality therapies.
Robert E. Chew, PE
Chairman of the Board
317.710.1530 (m)
Robert.Chew@CAIReady.com