1. 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 , 2002
One Quality Place
Edison, NJ 08820
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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. Manufacturing & Administrative
Why Six Sigma?
Six Sigma embraces both continuous improvement and breakthrough performance. The process includes models for manufacturing, design and administrative services
Manufacturing & Administrative
Define Measure Analyze Improve Control
Generally accepted model (most literature) also: plan, do, check, act.
Define Measure Analyze Design Verify
Design For Six Sigma (DFSS)

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. Visit Our Web Site At: www.statamatrix.com/fda
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