In early November 2003, Wyeth BioPharma, headquartered in Andover, MA, hosted the quarterly meeting of the BioPharma Operations Excellence Consortium. Approximately 50 people representing over 15 companies attended this first meeting of the consortium's newly established East Coast chapter.
The day's agenda included key industry topics such as the future of biogenerics, successful process transfer, supply-chain cycle-time reduction, and highlights from the Tefen-led "BioBenchmark Study."
Successful Process Transfer Blair Okita, Sr., vice president of therapeutics manufacturing and development at Genzyme, discussed elements of process transfer. He addressed the risks and rewards of standardizing on a single platform the development of products, and making the products fit within that platform. He also explored how human capital supports process transfer. Genzyme uses a structure that includes a technical support role, focusing on the management of communications and scheduling of process transfers. A final, important component of process transfer is data collection, in the form of statistical process controls. By continuously tracking the process parameters in production, troublesome trends and out-of-specification conditions can be quickly observed and appropriate action taken to drive overall process improvement.
Reducing Cycle Time Allen Jacques, director of production control for Wyeth BioPharma, discussed his company's effort to compress the overall cycle time of its product supply chain. Wyeth BioPharma has a highly complex biopharmaceutical product supply chain because the company deals with a large number of customers and contract sites all over the world. The biggest challenge Wyeth faces is maintaining an effective and efficient flow of information. By the time demand figures work their way up the communication chain and product moves down the supply route, market needs may have changed. To battle these challenges, Wyeth has focused on improving the quality and frequency of communication and coordination with all supply and demand points, providing much more responsive manufacturing. The company has accomplished this by implementing a corporate data warehouse, accessed and populated by all affected parties. The effort has been supplemented by activities - conducted by cycle-time reduction teams - focusing on improvements at relevant sites. The main objective of these teams is the reduction of overall disposition times through more efficient batch record review and deviation investigations.
As demonstrated through Wyeth's case study - and validated by Tefen's own industry experience - batch record review and deviation management typically are the business processes with the greatest contribution (and improvement potential) to a company's cycle-time performance. Although deviation management is starting to receive the operations-focused attention it deserves (for example, business process reengineering efforts, automated deviation management, and corrective and preventive action [CAPA] information systems), the batch record review process still lacks the required operations-centric focus, usually resulting in poor performance.
Tefen's practice shows that the following elements must be in place in order to implement and maintain an efficient and effective batch record review process:
Figure 1 illustrates these main elements and their interdependencies.
A comprehensive cycle-time reduction study conducted by a large biopharmaceutical manufacturing company concluded that the most significant contributing factor to lengthy cycle times is the extremely long batch record review process due primarily to frequent documentation errors. The company's executive team accepted the diagnosis and the recommended improvement roadmap and formed a 12-month improvement program targeting significant enhancement in the organization's "right first time" documentation metrics. The results of the program were impressive with a more than 60% reduction in errors and a 35% reduction in overall disposition cycle time.