It is safe to say the pharmaceutical and biotech market today bears little resemblance to the market of the last twenty years. The rapid advancement of emerging markets that drive down the standard cost of therapy has forced the industry to look for ways to catalyze business performance and manage risk while still maintaining shareholder value. Historically, we have been slow to embrace innovation. However, the FDA’s landmark guidance in 2004 — cGMPs for the 21st Century - A Risk Based Approach — challenged us to find better ways to develop our products, taking up the mantra of mechanistic understanding and a processcentric approach to quality assurance. This new philosophy has opened the door to proven improvement frameworks such as Lean Manufacturing, Six Sigma,* and Design for Manufacturing to gain a foothold in our product development lifecycles. While at first blush these approaches seem focused on catalyzing process performance, in reality, each has a tangible impact on process stability and predictability. This stabilization is due to several factors. Mechanistic understanding allows any process to be better controlled. Whether the process is transactional, requiring an individual to complete a task and behave as expected, or a manufacturing unit operation essential to product performance, these improvement philosophies leverage the basic principle of standardized work practices. This approach is often captured under the umbrella of “Operational Excellence.”

Standardized work practices strive to design process steps that encourage or enforce execution the same way every time. From a Lean Manufacturing perspective, standardized work practices allow an operation to optimize its process velocity. From a Six Sigma perspective, it eliminates another source of variability that can cloud the true variability of the process. While traditionally applied to the process, these approaches can be extended to the design of the facility, creating an environment that is conducive to greater process and operational predictability.

FACILITY DESIGN CONSIDERATIONS
Applying the principles of Lean Manufacturing to facility design is nothing new. The Lean facility design roadmap mirrors the approach to standard facility design. While all facilities consider the operations that will take place in the facility, Lean design takes these considerations to a new level. Lean facilities marry classical design component criteria (material, personnel, equipment, and finished product flow) with operational considerations such as information flow, performance, and value stream measurement. This distinction is the essence of the competitive advantage created by Lean facilities.

The result of Lean facility design is an operation which is better aligned with needs of the business in terms of flexibility to respond to market fluctuations, reduced indirect and direct labor requirements, and better information process flow. In this era of dwindling equity markets for capital expansion, industry has no choice but to find a way to do more with less and move toward multi-functional facilities, often having to handle products with widely varying biosafety levels, manufacturing steps and escalating levels of complexity. Each of these challenges by itself represents a significant problem for controlling operating variation, but when combined, they can present an almost untenable scenario. Given the reality of this new marketplace, it is essential to look at new ways to apply the proven principles of operational excellence to minimize the impact of process and procedural variation.

FACILITY DESIGN AND TRAINING
Classical facility design exercises revolve around analyzing the process streams for the operation and building the support and information corridors around them. Lean facility design takes this one step further and seeks to optimize the relationship process requirements and business performance by eliminating inefficiency throughout the value stream for each product or process. There are several areas within facility design and construction that can be leveraged in terms of promoting process predictability, where the facility becomes a part of the overall cGMP training strategy.