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One Quality Place Edison, NJ 08820 732-906-6155 e-mail: smarash@thesamgroup.com Visit: www.statamatrix.com/fda

The Interrelationship between PAT and Six Sigma Presented by Dr. Stanley A. Marash, P.E. Chairman and CEO STAT-A-MATRIX/The SAM Group Food and Drug Administration - PAT Pharmaceutical Science Advisory Committee Meeting October 21-23, 2002. One Quality Place Edison, NJ 08820

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One Quality Place Edison, NJ 08820 732-906-6155 e-mail: smarash@thesamgroup.com Visit: www.statamatrix.com/fda

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  1. The Interrelationship between PAT and Six Sigma Presented byDr. Stanley A. Marash, P.E. Chairman and CEO STAT-A-MATRIX/The SAM Group Food and Drug Administration - PATPharmaceutical Science Advisory Committee Meeting October 21-23, 2002 One Quality Place Edison, NJ 08820 732-906-6155e-mail: smarash@thesamgroup.com Visit: www.statamatrix.com/fda

  2. Motivation • Significant potential and need exists for improving the efficiencies of pharmaceutical manufacturing and associated regulatory processes (Dr. Ajaz S. Hussain - May 8, 2002)

  3. PAT • Technological opportunities (e.g. PAT) available for realizing this potential–but industry reluctant due to regulatory uncertainties (Dr. Hussain)

  4. Six Sigma • Many aspects of the industry have adopted Six Sigma. Both PAT and 6s are process oriented approaches to achieving efficiencies, reduced cycle time and improved quality 6s

  5. Why PAT? • PAT provides an opportunity to move from the current “testing to document quality” paradigm to a “continuous quality assurance” paradigm that can improve our ability to ensure quality was “built-in” or was “by design” – ultimate realization of the true spirit of cGMP. (Dr. Hussain)

  6. Define Measure Analyze Improve Control Why Six Sigma? • Six Sigma embraces both continuous improvement and breakthrough performance. The process includes models for manufacturing, design and administrative services Manufacturing & Administrative Design For Six Sigma (DFSS) Define Measure Analyze Design Verify

  7. Goals and Objectives • Using PAT as a model technological opportunity, develop a regulatory framework to facilitate introduction of new manufacturing technologies that enhance process efficiencies and understanding • Identify and eliminate perceived/real regulatory hurdles • Develop a dynamic, team based, scientific approach for regulatory assessment…of new technologies (Dr. Hussain)

  8. PAT • Can PAT win the industry’s confidence or are the perceived/real “regulatory hurdles” too difficult to overcome?

  9. Six Sigma • Does Six Sigma have the advantage of: • No (or less) regulatory constraints • Perception of an industry program not an agency program

  10. Fusion ManagementTM • A tool for fusing PAT and Six Sigma to overcome the existing constraints

  11. For More Information Visit Our Web Site At: www.statamatrix.com/fda

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