Efficient Compliance Without Re-inventing the Wheel

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.

Bornsztejn

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.

Collins

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