Pharmaceutical Processing - July 2008 - cResults - (Page 1)

Month 2008 1 p h a r m p r o. c o m July 2008 Official Media Sponsor of INTERPHEX2009™ N E W T E C H N O L O G Y F O R T H E P H A R M A C E U T I C A L I N D U S T RY Managing Efficiency in a Quality Organization Par Pharmaceutical realizes significant increases in value and efficiency through operation By Joe Barbarite, Par Pharmaceutical and Rafi Maslaton, cResults n today’s business environment, a quality organization that focuses strictly on compliance while ignoring inefficiency will not succeed. Operational challenges such as cost reduction, cycle time reduction, improved efficiency, Right First Time, and schedule adherence are recognized as imperative issues. In response to high pressure on manufacturers to improve their value added contribution, the life science industry has progressed to a more efficient and competitive industry in recent years. Many companies are leveraging Lean and Six Sigma 3,4,5,6 as the main umbrellas to host a range of various operation excellence and cost reduction initiatives. However, while manufacturing and packaging remained the major focus, quality operations have yet to garner the same attention. Traditionally, the quality function has been reactive with limited visibility to future needs of the business. Resources are typically added as a result of increasing backlog and cycle time. More recently, laboratories have been engaged in operational excellence initiatives, while QA has, for the most part, been left behind. I This article discusses efficiency management throughout the quality operations including QC laboratories and QA operations. In addition, it outlines how Par Pharmaceutical has addressed operational excellence in its quality operations and how it improves its cost effectiveness and enhances its compliance value added contribution to manufacturing and packaging operations at its Spring Valley, New York site. QC Operational Excellence Journey The journey for operational excellence in quality operation began with QC laboratories. Par, a developer, manufacturer and marketer of generic drugs, and cResults, an operation consulting firm, initiated an improvement program in mid -2006. The goal was to provide Par’s supply chain with the highest service level and quality in a cost-effective manner. The project team, leveraging lean 3,4,5,6 techniques, performed an assessment to identify opportunities for improvements and develop a detailed road map for improvements. The assessment also included the establishment of QC time standards that were used to quantify the expected benefits of the proposed improvement plan and became the foundation for efficiency tracking and a long-term capacity planning tool. During the assessment key building blocks (Figure 1) were outlined to achieve operational excellence and were identified and implemented in the following phase. The continuous improvement initiatives included the following key projects: * Establish accurate standards and develop a resource planning tool: To become more proactive and balance the workload between the various labs in response to product mix changes and volume fluctuation. The standards are used to project laboratory workload based on incoming samples and better prepare for peaks in sample volume. This helps reduce overtime and overall resource requirements. This tool is used for cost allocation, budgeting and long-term resource planning. * Improve our campaigning and overall efficiency: The benefit of campaigning in manufacturing and packaging has been long established and similar efficiency gains can be obtained in a laboratory. This initiative provided improved business processes supported by a computerized tool to view the upcoming stability samples, and im- Figure 1: Key Building Blocks to Achieve Operational Excellence

Table of Contents for the Digital Edition of Pharmaceutical Processing - July 2008 - cResults

Pharmaceutical Processing - July 2008 - cResults