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Learning From Other Industries

G. K. Raju, PhD
Light Pharma Inc.
October 2011

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OUTLINE

• Background
• ICH Q10
• Looking at Other Industries
– General
– Specific

• Summary
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.THE ECONOMIST: August 31st 2002 Pharmaceuticals: “Trouble in the making” “For all the glamour of invention.” 3 .  Witness the slew of drug makers that have  fallen foul of the FDA. can unravel if manufacturing falters. like the hottest new  fashion. the latest  blockbuster medicine. their regulator in  America….

. 4 .The Wall Street Journal:  September 3rd 2003 New Prescription For Drug Makers:  Update the Plants “The Pharmaceutical Industry Has A Little  Secret: Even as it invents futuristic new  drugs. its manufacturing techniques lag far  behind those of potato‐chip and laundry‐ soap makers.” “You need to improve” – Dr. McClellan lectured  the industry.

 ” she says because  “manufacturing techniques were outmoded.” 5 .  Just  refining procedures and documentation wasn’t  going to change that.  Yet “we still weren’t seeing  acceptable levels of quality.The Wall Street Journal:  September 3rd 2003 New 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.

OUTLINE • Background • ICH Q10 • Looking at Other Industries – General – Specific • Summary 6 .

ICH Q10 “ICH Q10 describes one comprehensive model for an  effective pharmaceutical quality system that is based  on International Organization for Standardization  (ISO) quality concepts.”3 “ 7 . and  complements ICH “Q8 Pharmaceutical Development” and ICH “Q9 Quality Risk Management. includes applicable good  manufacturing practice (GMP) regulations.

” 8 .ICH Q10 “Implementation of ICH Q10 throughout the product  lifecycle should facilitate innovation and continual  improvement and strengthen the link between  pharmaceutical development and manufacturing  activities.

OUTLINE • Background • ICH Q10 • Looking at Other Industries – General – Specific • Summary 9 .

• Description • Identity • Assay • CU • Impurity • Dissolution 1. 1.QUALITY • Cmax • AUC Quality System 3c. 3b. 10 . Clinical Performance Critical Quality Attributes • Process • Materials • Controls • API Attributes • Impurities 2. 3a.

 Juran] – Conformance to Requirements [Crosby] – Plan‐Do‐Check‐Act (PDCA/PDSA) [Deming/Shewhart] • “Quality” – Quality of Product – Quality of Process – Quality System 11 . M.QUALITY • “Quality” – Fitness For Use [J.

 Variation.  Edwards Deming – System of Profound Knowledge • System. Knowledge.Learning from other industries: Quality Philosophies • W. Psychology – 14 Principles • Philip Crosby – ‘Quality is Free” (1979) – “Quality Management Maturity” 12 .

13 .. Quality is everyone's responsibility... neither is survival.. We are here to make another world. Learning is not compulsory. Edwards Deming • • • • • A bad system will beat a good person every time Lack of knowledge.Learning from other industries: W. that is the problem.

Learning from other industries: Focus and Cost of Quality CONSENT DECREE WARNING LETTER External Failure Common Focus FDA 483 RECALLS COMPLAINTS Cost Of Quality REJECTS QA APPROVAL FINAL QC TESTING Internal Failure Appraisal IN-PROCESS TESTING DEVELOPMENT Prevention Where “Right” is Measured 14 .

Wet Granulation BLEND MILLING COMPRESS “Here” FILM COATING BOTTLE PACKAGING 15 WEIGHING FB DRY BLEND .Learning from other industries: Process Maturity SYSTEM E: COMPRESS FILM COATING “There” BOTTLE PACKAGING (e.g. direct compression.g. Continuous processing) WEIGHINGBLEND SYSTEM D: GRANULATION WEIGHING SYSTEM C: FB DRY GRANULATION WEIGHING MILLING COMPRESS MILLING COMPRESS SYSTEM A: MILLING FB DRY GRANULATION FILM COATING BOTTLE PACKAGING FILM COATING BOTTLE PACKAGING BLEND SYSTEM B: WEIGHING BOTTLE PACKAGING BLEND FB DRY GRANULATION FILM COATING COMPRESS e.

Learning from other industries: Change 16 .

Existing Products (Tactical) Knowledge -Cost.Industry .Learning from other industries: Quality and Business Benefit FINANCIAL INVESTMENT ($) FINANCIAL RETURNS ($) .Industry . Time System Capability (Robustness) Knowledge GRANULATION MILLING GRANULATION MILLING GRANULATION MILLING . Quality.New Products (Strategic) .Society .Society LEVERAGES PERFORMANCE .

OUTLINE • Background • ICH Q10 • Looking at Other Industries – General – Specific • Summary 18 .

Learning from other industries: Maturity Models • General – Quality Management Maturity (Crosby) – People Maturity Model – Business Process Maturity Model  – ISO 9004 • Specific – Capability Maturity Model  19 .

Learning from other industries: Sigma Level & Cost of Quality Semicon Pharma/Biotech • Red Zone Products Have 25% COQ% Improvement Opportunity • Yellow Zone Products Have 10% COQ% Improvement Opportunity • Green Zone Can Capture Opportunity Now 20 .

Learning from other industries: Industry Specific Model • General – ISO 9001: 2008 • Industry Specific  – Tick IT – Tick IT Plus – CMMi 21 .

 Benchmarks & Best Practices Defect Density measured in terms of #defects/function point 22 .Learning from other industries: Process Maturity and Product Quality: SOFTWARE Defect Density Process Maturity Reference:  Caper Jones. Software Assessment.

Learning from other industries: Process Maturity and Cost of Quality: SOFTWARE: Knox (1993) Prevention Appraisal Int Failure Ext Failure TCoSQ Cost as a Percent of Development 60 50 40 30 20 10 0 1 2 3 SEI CMM Level 4 5 23 .

Learning from other industries: Quality and Other Measures of  Performance SOFTWARE: Software Enterprise Institute (2006) 24 .

OUTLINE • Background • ICH Q10 • Looking at Other Industries – General – Specific • Summary 25 .

SUMMARY • Our Quality Systems must enable more of the kind and  extent of lifecycle improvement and innovation we  need and seek • Q10 is a significant step in that direction • Additional level of granularity can help to build on it  • Learning from other industries can help us do that 26 .