May Feature

Technology Helps Manufacturers Create a Manufacturing Compliance Platform - continued

Conclusion Pharmaceutical manufacturers need effective tools to help them compete in today’s evolving marketplace. Regulatory and compliance demands, if not addressed properly, can lead to costly processes and inefficiencies. The pharmaceutical industry has not traditionally incorporated business processes such as Lean Manufacturing and Six Sigma into its infrastructures. Manufacturers can create manufacturing compliance platforms by combining process analytical technology with Six Sigma and Lean Manufacturing to help them operate at optimal efficiency and produce high quality products at the lowest cost. The result is better, safer products for consumers and improved bottom line performance for manufacturers. References 1. R.H. Scherzer, “Quality by Design: A Challenge to the Pharma Industry,” presentation at the Consortium for the Advancement of Manufacturing in Pharmaceuticals (CAM, March 2002). 2. Food and Drug Administration, “Pharmaceutical CGMPs for the Twenty-First Century, A Risk-Based Approach: Final Report” (FDA, Rockville, MD 2004). 3. M. Harry and R. Schroeder, The Breakthrough Management Strategy Revolutionizing the World’s Top Corporations, (Currency Book, New York, 2000). 4. M.L. George, Lean Six Sigma (McGraw-Hill, New York, NY, 1st ed. 2002). 5. A. Hussain, FDA, “The Process Analytical Technology (PAT) Initiative: PAT and the Pharmacopoeias,” presentation at the EDQM Spring Conference, Cannes, France, May 3–4, 2004. PT