logging in or signing up Pat Manufacturing aSGuest609 Download Post to : URL : Related Presentations : Share Add to Flag Embed Email Send to Blogs and Networks Add to Channel Uploaded from authorPOINT lite Insert YouTube videos in PowerPont slides with aS Desktop Copy embed code: (To copy code, click on the text box) Embed: URL: Thumbnail: WordPress Embed Customize Embed The presentation is successfully added In Your Favorites. Views: 554 Category: Science & Tech.. License: All Rights Reserved Like it (1) Dislike it (0) Added: October 09, 2008 This Presentation is Public Favorites: 0 Presentation Description No description available. Comments Posting comment... Premium member Presentation Transcript PAT, Manufacturing Science, QbD: Three Years After Introduction….What Are The Expectations? : PAT, Manufacturing Science, QbD: Three Years After Introduction….What Are The Expectations? G.K. Raju, Ph.D. Light Pharma Inc. September 2006 Outline : Outline BACKGROUND A FRAMEWORK CURRENT MOMENTUM EXPECTATIONS NEXT STEPS Pharmaceutical Manufacturing : Pharmaceutical Manufacturing Research Development Manufacturing Marketing Pharmaceutical Manufacturing : ACTIVE FORMULN FILL PACK ACTIVE FORMULN FILL PACK ACTIVE FORMULN FILL PACK RESEARCH DEVELOPMENT MANUFACTURING TIME SPACE COST QUALITY TIME SAFETY Pharmaceutical Manufacturing FDA WARNING LETTERSTo Brand Drug Manufacturers : FDA WARNING LETTERSTo Brand Drug Manufacturers Abbott Laboratories AstraZeneca Aventis Baxter Healthcare Bayer Corporation Boehringer Ingelheim Bristol-Myers Squibb Eli Lilly Glaxo SmithKline Hoffmann-LaRoche Johnson and Johnson Merck & Company Novartis Pharmaceuticals Pfizer Pharmacia Schering The Wall Street Journal: September 3rd 2003New Prescription For Drug Makers: Update the Plants : The Wall Street Journal: September 3rd 2003New Prescription For Drug Makers: Update the Plants “Janet Woodcock was among the architects of an FDA Crackdown under which the agency fined drug makers as much as $500 million for manufacturing failures in recent years. Yet “we still weren’t seeing acceptable levels of quality, ” she says because “manufacturing techniques were outmoded. Just refining procedures and documentation wasn’t going to change that.” -- Wall Street Journal, Sept 3rd 2003 Pharmaceutical Manufacturing : Research Development Manufacturing Marketing ???? Pharmaceutical Manufacturing PHARMACEUTICAL MANUFACTURING:A Social Capability : PHARMACEUTICAL MANUFACTURING:A Social Capability BACKGROUND:NOT Quality By Design : BACKGROUND:NOT Quality By Design Outline : Outline BACKGROUND A FRAMEWORK CURRENT MOMENTUM EXPECTATIONS NEXT STEPS FRAMEWORK:A. Science B. System C. Capability : FRAMEWORK:A. Science B. System C. Capability Mfg Science C. Manufacturing Capability (Robustness) PERFORMANCE Cost, Quality, Time B. Manufacturing System LEVERAGES New Products (Strategic) Existing Products (Tactical) A. Manufacturing Science A. Manufacturing ScienceCurrent State vs. Desired State : A. Manufacturing ScienceCurrent State vs. Desired State Mfg. Science LEVEL 1 LEVEL 2 LEVEL 4 LEVEL 5 LEVEL 3 CORRELATIVE KNOWLEDGE What Is Correlated to What? “CAUSAL" KNOWLEDGE What “Causes” What? MECHANISTIC KNOWLEDGE How? First Principles Why? DESCRIPTIVE KNOWLEDGE: What? “There” “Here” FRAMEWORK:A. Science B. System C. Capability : FRAMEWORK:A. Science B. System C. Capability Mfg Science C. Manufacturing Capability (Robustness) PERFORMANCE Cost, Quality, Time B. Manufacturing System LEVERAGES New Products (Strategic) Existing Products (Tactical) A. Manufacturing Science B. Manufacturing SystemCurrent State vs. Desired State : B. Manufacturing SystemCurrent State vs. Desired State FRAMEWORK:A. Science B. System C. Capability : FRAMEWORK:A. Science B. System C. Capability Mfg Science C. Manufacturing Capability (Robustness) PERFORMANCE Cost, Quality, Time B. Manufacturing System LEVERAGES New Products (Strategic) Existing Products (Tactical) A. Manufacturing Science Outline : Outline BACKGROUND A FRAMEWORK CURRENT MOMENTUM EXPECTATIONS NEXT STEPS FRAMEWORK:A. Science B. System C. Capability : FRAMEWORK:A. Science B. System C. Capability Mfg Science C. Manufacturing Capability (Robustness) PERFORMANCE Cost, Quality, Time B. Manufacturing System LEVERAGES New Products (Strategic) Existing Products (Tactical) A. Manufacturing Science A. Manufacturing ScienceCurrent State vs. Desired State : A. Manufacturing ScienceCurrent State vs. Desired State Mfg. Science LEVEL 1 LEVEL 2 LEVEL 4 LEVEL 5 LEVEL 3 CORRELATIVE KNOWLEDGE What Is Correlated to What? “CAUSAL" KNOWLEDGE What “Causes” What? MECHANISTIC KNOWLEDGE How? First Principles Why? DESCRIPTIVE KNOWLEDGE: What? “There” “Here” A. MANUFACTURING SCIENCEConsortia: Facilitating Discussion and Knowledge Creation : A. MANUFACTURING SCIENCEConsortia: Facilitating Discussion and Knowledge Creation ACTIVE FORMULN FILL PACK ACTIVE FORMULN FILL PACK ACTIVE FORMULN FILL PACK RESEARCH DEVELOPMENT MANUFACTURING e.g. CAMP ERC Govt VP Development VP Operations Regulatory FDA Scientist FDA Applied Scientist FDA Policy Makers FDA Inspector A. MANUFACTURING SCIENCEConsortia: Facilitating Discussion and Knowledge Creation : A. MANUFACTURING SCIENCEConsortia: Facilitating Discussion and Knowledge Creation ACTIVE FORMULN FILL PACK ACTIVE FORMULN FILL PACK ACTIVE FORMULN FILL PACK RESEARCH DEVELOPMENT MANUFACTURING e.g. CAMP Other Govt VP Development VP Operations Regulatory FDA Scientist FDA Applied Scientist FDA Policy Makers FDA Inspector A. MANUFACTURING SCIENCE : A. MANUFACTURING SCIENCE Consortia Industry, Academia Industry Development, Manufacturing Academia Pharmaceutical Engineering Regulatory Office of Testing and Research ONDQA FRAMEWORK:A. Science B. System C. Capability : FRAMEWORK:A. Science B. System C. Capability Mfg Science C. Manufacturing Capability (Robustness) PERFORMANCE Cost, Quality, Time B. Manufacturing System LEVERAGES New Products (Strategic) Existing Products (Tactical) A. Manufacturing Science B. Manufacturing SystemCurrent State vs. Desired State : B. Manufacturing SystemCurrent State vs. Desired State B. Manufacturing SystemTransformations : B. Manufacturing SystemTransformations Wyeth Research Dominic Ventura, Parimal Desai Bristol Myers Squibb Robert Lipper, San Kiang GlaxoSmithKline Gordon Muirhead Novartis James Cheney Manufacturing System:Regulatory Interactions : Manufacturing System:Regulatory Interactions NDA Submission NDA Approval Office of Compliance CMC Submissions Supplements Annual Reports PreApproval Inspections Compliance Inspections Office Of Biotechnology Products Office Of New Drug Quality Assurance US Food and Drug Administration Office Of The Commissioner Office Of Generic Drugs Office Of Testing &Research DESIGN SPACEWhich One and When? : DESIGN SPACEWhich One and When? Clinical Performance Critical Quality Attributes Process Materials Controls API Attributes Impurities 1. Cmax AUC Description Identity Assay CU Impurity Dissolution 2. 3. Parameters FRAMEWORK:A. Science B. System C. Capability : FRAMEWORK:A. Science B. System C. Capability Mfg Science C. Manufacturing Capability (Robustness) PERFORMANCE Cost, Quality, Time B. Manufacturing System LEVERAGES New Products (Strategic) Existing Products (Tactical) A. Manufacturing Science C. Manufacturing Capability : C. Manufacturing Capability Pfizer Others… Outline : Outline BACKGROUND A FRAMEWORK CURRENT MOMENTUM EXPECTATIONS NEXT STEPS Pharmaceutical Manufacturing: An Inside-Out View That Enables A Systems View : Pharmaceutical Manufacturing: An Inside-Out View That Enables A Systems View QbD At Social Level:Social Economic Consequences : QbD At Social Level:Social Economic Consequences TODAY Expectations : Expectations Social Discussion and Knowledge Creation Will Continue Regulatory Flexibility Will Continue and Expand Individual Champions Can Build On Early Success We will get help from the “outside” Economic Benefits May Begin To Gain Momentum NEXT THREE YEARSWhat I Hope to See More Of : NEXT THREE YEARSWhat I Hope to See More Of More Product Based Performance Measure Driven Real Design Space involving Clinical During Commercial Manufacturing CEO Involvement Much Larger Social Investment Closer Connectivity Between Review and Inspection Outline : Outline BACKGROUND A FRAMEWORK CURRENT MOMENTUM EXPECTATIONS NEXT STEPS FRAMEWORK:A. Science B. System C. Capability : FRAMEWORK:A. Science B. System C. Capability Mfg Science C. Manufacturing Capability (Robustness) PERFORMANCE Cost, Quality, Time B. Manufacturing System LEVERAGES New Products (Strategic) Existing Products (Tactical) A. Manufacturing Science NEXT STEPS : NEXT STEPS “We must be the changes we wish to see in the world.” – Mahatma Gandhi You do not have the permission to view this presentation. In order to view it, please contact the author of the presentation.
Pat Manufacturing aSGuest609 Download Post to : URL : Related Presentations : Share Add to Flag Embed Email Send to Blogs and Networks Add to Channel Uploaded from authorPOINT lite Insert YouTube videos in PowerPont slides with aS Desktop Copy embed code: (To copy code, click on the text box) Embed: URL: Thumbnail: WordPress Embed Customize Embed The presentation is successfully added In Your Favorites. Views: 554 Category: Science & Tech.. License: All Rights Reserved Like it (1) Dislike it (0) Added: October 09, 2008 This Presentation is Public Favorites: 0 Presentation Description No description available. Comments Posting comment... Premium member Presentation Transcript PAT, Manufacturing Science, QbD: Three Years After Introduction….What Are The Expectations? : PAT, Manufacturing Science, QbD: Three Years After Introduction….What Are The Expectations? G.K. Raju, Ph.D. Light Pharma Inc. September 2006 Outline : Outline BACKGROUND A FRAMEWORK CURRENT MOMENTUM EXPECTATIONS NEXT STEPS Pharmaceutical Manufacturing : Pharmaceutical Manufacturing Research Development Manufacturing Marketing Pharmaceutical Manufacturing : ACTIVE FORMULN FILL PACK ACTIVE FORMULN FILL PACK ACTIVE FORMULN FILL PACK RESEARCH DEVELOPMENT MANUFACTURING TIME SPACE COST QUALITY TIME SAFETY Pharmaceutical Manufacturing FDA WARNING LETTERSTo Brand Drug Manufacturers : FDA WARNING LETTERSTo Brand Drug Manufacturers Abbott Laboratories AstraZeneca Aventis Baxter Healthcare Bayer Corporation Boehringer Ingelheim Bristol-Myers Squibb Eli Lilly Glaxo SmithKline Hoffmann-LaRoche Johnson and Johnson Merck & Company Novartis Pharmaceuticals Pfizer Pharmacia Schering The Wall Street Journal: September 3rd 2003New Prescription For Drug Makers: Update the Plants : The Wall Street Journal: September 3rd 2003New Prescription For Drug Makers: Update the Plants “Janet Woodcock was among the architects of an FDA Crackdown under which the agency fined drug makers as much as $500 million for manufacturing failures in recent years. Yet “we still weren’t seeing acceptable levels of quality, ” she says because “manufacturing techniques were outmoded. Just refining procedures and documentation wasn’t going to change that.” -- Wall Street Journal, Sept 3rd 2003 Pharmaceutical Manufacturing : Research Development Manufacturing Marketing ???? Pharmaceutical Manufacturing PHARMACEUTICAL MANUFACTURING:A Social Capability : PHARMACEUTICAL MANUFACTURING:A Social Capability BACKGROUND:NOT Quality By Design : BACKGROUND:NOT Quality By Design Outline : Outline BACKGROUND A FRAMEWORK CURRENT MOMENTUM EXPECTATIONS NEXT STEPS FRAMEWORK:A. Science B. System C. Capability : FRAMEWORK:A. Science B. System C. Capability Mfg Science C. Manufacturing Capability (Robustness) PERFORMANCE Cost, Quality, Time B. Manufacturing System LEVERAGES New Products (Strategic) Existing Products (Tactical) A. Manufacturing Science A. Manufacturing ScienceCurrent State vs. Desired State : A. Manufacturing ScienceCurrent State vs. Desired State Mfg. Science LEVEL 1 LEVEL 2 LEVEL 4 LEVEL 5 LEVEL 3 CORRELATIVE KNOWLEDGE What Is Correlated to What? “CAUSAL" KNOWLEDGE What “Causes” What? MECHANISTIC KNOWLEDGE How? First Principles Why? DESCRIPTIVE KNOWLEDGE: What? “There” “Here” FRAMEWORK:A. Science B. System C. Capability : FRAMEWORK:A. Science B. System C. Capability Mfg Science C. Manufacturing Capability (Robustness) PERFORMANCE Cost, Quality, Time B. Manufacturing System LEVERAGES New Products (Strategic) Existing Products (Tactical) A. Manufacturing Science B. Manufacturing SystemCurrent State vs. Desired State : B. Manufacturing SystemCurrent State vs. Desired State FRAMEWORK:A. Science B. System C. Capability : FRAMEWORK:A. Science B. System C. Capability Mfg Science C. Manufacturing Capability (Robustness) PERFORMANCE Cost, Quality, Time B. Manufacturing System LEVERAGES New Products (Strategic) Existing Products (Tactical) A. Manufacturing Science Outline : Outline BACKGROUND A FRAMEWORK CURRENT MOMENTUM EXPECTATIONS NEXT STEPS FRAMEWORK:A. Science B. System C. Capability : FRAMEWORK:A. Science B. System C. Capability Mfg Science C. Manufacturing Capability (Robustness) PERFORMANCE Cost, Quality, Time B. Manufacturing System LEVERAGES New Products (Strategic) Existing Products (Tactical) A. Manufacturing Science A. Manufacturing ScienceCurrent State vs. Desired State : A. Manufacturing ScienceCurrent State vs. Desired State Mfg. Science LEVEL 1 LEVEL 2 LEVEL 4 LEVEL 5 LEVEL 3 CORRELATIVE KNOWLEDGE What Is Correlated to What? “CAUSAL" KNOWLEDGE What “Causes” What? MECHANISTIC KNOWLEDGE How? First Principles Why? DESCRIPTIVE KNOWLEDGE: What? “There” “Here” A. MANUFACTURING SCIENCEConsortia: Facilitating Discussion and Knowledge Creation : A. MANUFACTURING SCIENCEConsortia: Facilitating Discussion and Knowledge Creation ACTIVE FORMULN FILL PACK ACTIVE FORMULN FILL PACK ACTIVE FORMULN FILL PACK RESEARCH DEVELOPMENT MANUFACTURING e.g. CAMP ERC Govt VP Development VP Operations Regulatory FDA Scientist FDA Applied Scientist FDA Policy Makers FDA Inspector A. MANUFACTURING SCIENCEConsortia: Facilitating Discussion and Knowledge Creation : A. MANUFACTURING SCIENCEConsortia: Facilitating Discussion and Knowledge Creation ACTIVE FORMULN FILL PACK ACTIVE FORMULN FILL PACK ACTIVE FORMULN FILL PACK RESEARCH DEVELOPMENT MANUFACTURING e.g. CAMP Other Govt VP Development VP Operations Regulatory FDA Scientist FDA Applied Scientist FDA Policy Makers FDA Inspector A. MANUFACTURING SCIENCE : A. MANUFACTURING SCIENCE Consortia Industry, Academia Industry Development, Manufacturing Academia Pharmaceutical Engineering Regulatory Office of Testing and Research ONDQA FRAMEWORK:A. Science B. System C. Capability : FRAMEWORK:A. Science B. System C. Capability Mfg Science C. Manufacturing Capability (Robustness) PERFORMANCE Cost, Quality, Time B. Manufacturing System LEVERAGES New Products (Strategic) Existing Products (Tactical) A. Manufacturing Science B. Manufacturing SystemCurrent State vs. Desired State : B. Manufacturing SystemCurrent State vs. Desired State B. Manufacturing SystemTransformations : B. Manufacturing SystemTransformations Wyeth Research Dominic Ventura, Parimal Desai Bristol Myers Squibb Robert Lipper, San Kiang GlaxoSmithKline Gordon Muirhead Novartis James Cheney Manufacturing System:Regulatory Interactions : Manufacturing System:Regulatory Interactions NDA Submission NDA Approval Office of Compliance CMC Submissions Supplements Annual Reports PreApproval Inspections Compliance Inspections Office Of Biotechnology Products Office Of New Drug Quality Assurance US Food and Drug Administration Office Of The Commissioner Office Of Generic Drugs Office Of Testing &Research DESIGN SPACEWhich One and When? : DESIGN SPACEWhich One and When? Clinical Performance Critical Quality Attributes Process Materials Controls API Attributes Impurities 1. Cmax AUC Description Identity Assay CU Impurity Dissolution 2. 3. Parameters FRAMEWORK:A. Science B. System C. Capability : FRAMEWORK:A. Science B. System C. Capability Mfg Science C. Manufacturing Capability (Robustness) PERFORMANCE Cost, Quality, Time B. Manufacturing System LEVERAGES New Products (Strategic) Existing Products (Tactical) A. Manufacturing Science C. Manufacturing Capability : C. Manufacturing Capability Pfizer Others… Outline : Outline BACKGROUND A FRAMEWORK CURRENT MOMENTUM EXPECTATIONS NEXT STEPS Pharmaceutical Manufacturing: An Inside-Out View That Enables A Systems View : Pharmaceutical Manufacturing: An Inside-Out View That Enables A Systems View QbD At Social Level:Social Economic Consequences : QbD At Social Level:Social Economic Consequences TODAY Expectations : Expectations Social Discussion and Knowledge Creation Will Continue Regulatory Flexibility Will Continue and Expand Individual Champions Can Build On Early Success We will get help from the “outside” Economic Benefits May Begin To Gain Momentum NEXT THREE YEARSWhat I Hope to See More Of : NEXT THREE YEARSWhat I Hope to See More Of More Product Based Performance Measure Driven Real Design Space involving Clinical During Commercial Manufacturing CEO Involvement Much Larger Social Investment Closer Connectivity Between Review and Inspection Outline : Outline BACKGROUND A FRAMEWORK CURRENT MOMENTUM EXPECTATIONS NEXT STEPS FRAMEWORK:A. Science B. System C. Capability : FRAMEWORK:A. Science B. System C. Capability Mfg Science C. Manufacturing Capability (Robustness) PERFORMANCE Cost, Quality, Time B. Manufacturing System LEVERAGES New Products (Strategic) Existing Products (Tactical) A. Manufacturing Science NEXT STEPS : NEXT STEPS “We must be the changes we wish to see in the world.” – Mahatma Gandhi