Bornsztejn
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Regulatory compliance remains a critical issue facing the biopharmaceutical industry. Poor and incorrect validation can cost
manufacturers millions of dollars in lost time. With increasingly stringent regulations, rising manufacturing costs, and decreasing
product pipelines, it is vital for manufacturers to achieve efficient and effective compliance of facilities, processes, and
equipment. One area of concern is facility validation. Many new biopharmaceutical facilities fail to go online on time because
the validation element of the build project runs over time and over budget.
Collins
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The problem has been exacerbated because the industry continues to follow a traditional and complex approach to facility validation,
in which validation planning starts during or after the facility design ends. This is too late and leads to problems throughout
the build and validation project. This must change if manufacturers are to achieve more efficient regulatory compliance. Furthermore,
there is often a divide between process development, facility validation, and ongoing facility compliance management, which
further compounds the problem.
A NEW APPROACH
Manufacturers must address the following issues to ensure improved compliance:
- Comprehension—industry knowledge of validation is highly variable; it is often not understood how badly validation can be
managed and what effect this can have on a business.
- Planning—validation is currently planned too late. Successful validation strategies are planned during basic facility design,
initiated before a facility is built, and set the stage for proper lifecycle management.
- Resources—manufacturers must understand that validating a facility is both time- and cost-intensive.
One new approach to improve compliance is to plan for validation before the facility is designed and to implement a modular
validation platform when building a facility. This involves thinking about validation holistically without simply launching
into the development of a detailed and comprehensive validation master plan (VMP) from the outset. Manufacturers currently
believe that such master plans must be compiled at an early stage. However, this adversely affects a validation project because
the VMP is a large, inflexible document that requires constant revisions and rewriting during the course of the facility build,
resulting in delayed go-live dates and product manufacturing.
A modular program sets out broad intentions and observations in high-level policy and master-plan documents that can be readily
adapted as the facility design and construction progresses. This allows specific details to be built into the modular plan
as the project evolves and provides more efficient compliance with full traceability back to the initial development and user
intentions.
EFFECTIVE COMPLIANCE
Moving away from traditional approaches to facility validation doesn't involve reinventing the wheel, but will help manufacturers
achieve efficient and well-planned validation, allowing greater regulatory compliance; increased standardization of protocols
and documents; and better employee appreciation of the processes involved.
With rising costs, a changing regulatory environment, and the availability of improved approaches to validation and document
management, now is the time for manufacturers to review facility validation procedures and establish effective platforms.
Implementing a modular approach will accelerate the time it takes to bring a facility online by eliminating unnecessary validation
while ensuring that the work required is performed and documented correctly and accurately.
Victor Bornsztejn is the global growth director and Brian Collins is the validation program director at GE Healthcare Services, Piscataway, NJ, 732.457.8056, victor.bornsztejn@ge.com
