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The Interrelationship between PAT and Six Sigma

Presented byDr. Stanley A. Marash, P.E.

Chairman and CEOSTAT-A-MATRIX/The SAM Group

Food and Drug Administration - PATPharmaceutical Science Advisory Committee Meeting

October 21-23, 2002

© 2002 STAT-A-MATRIX, All Rights Reserved#5147 FMOQ Rev. 1 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)

© 2002 STAT-A-MATRIX, All Rights Reserved#5147 FMOQ Rev. 1 3

PAT

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

© 2002 STAT-A-MATRIX, All Rights Reserved#5147 FMOQ Rev. 1 4

Six Sigma

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

© 2002 STAT-A-MATRIX, All Rights Reserved#5147 FMOQ Rev. 1 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)

© 2002 STAT-A-MATRIX, All Rights Reserved#5147 FMOQ Rev. 1 6

Why Six Sigma?

Define Measure Analyze Design Verify

Define Measure Analyze Improve Control

Six Sigma embraces both continuous improvement and breakthrough performance. The process includes models for manufacturing, design and administrative services

Design For Six Sigma (DFSS)

Manufacturing & Administrative

© 2002 STAT-A-MATRIX, All Rights Reserved#5147 FMOQ Rev. 1 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)

© 2002 STAT-A-MATRIX, All Rights Reserved#5147 FMOQ Rev. 1 8

PAT

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

© 2002 STAT-A-MATRIX, All Rights Reserved#5147 FMOQ Rev. 1 9

Six Sigma

Does Six Sigma have the advantage of:

No (or less) regulatory constraints

Perception of an industry program not an agency program

© 2002 STAT-A-MATRIX, All Rights Reserved#5147 FMOQ Rev. 1 10

Fusion ManagementTM

A tool for fusing PAT and Six Sigma to overcome the existing constraints

© 2002 STAT-A-MATRIX, All Rights Reserved#5147 FMOQ Rev. 1 11

For More Information

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