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Poska CbD/CMP 062910 Compliance by Design Building a Master Plan for Pharmaceutical Compliance Richard.Poska@A Global Pharmaceutical Regulatory Affairs Ultimate Risk of Non-compliance Death/AE When GMP Systems Fail 1999 KCl label mix-up 2000 Albuterol Dose 2006, 2008 Glycerin substituted with DEG 2007 Viracept genotoxic contaminant 2007 Methotrexate/cytarabine contamination 2008 Heparin adulterated 2009 Infant formula melamine adulteration 2009 Tylenol contamination Presentation Goals Propose concept of applying development approaches to compliance Stimulate discussion on unique approach with supporting information Use case-studies to explore application of concepts Explore future opportunities 1. Concept Leverage existing quality approaches to enable enhanced compliance. Specifically: Compliance by Design (CbD) Based on Quality by Design (QbD) Compliance Master Plan (CMP) Based on Validation Master Plans (VMP) 2a. Supporting Information Great achievements in process control PAT Rapid development of modern concepts understanding QbD Pharmaceutical compliance is multi-faceted BUT… Supporting Information People die from non-compliance Great achievements in process control PAT Rapid development of modern concepts QbD Pharmaceutical compliance is multi-faceted Deaths and adverse events still occurring PAT and QbD do not address compliance Business pressures are financial global FDA Compliance Initiatives are Multi-faceted Opportunities and Threats of Globalization Janet Woodcock March 2009 Opportunities Industry: cost savings, global opportunities for outsourcing ingredients Regulators: Science based regs, collaboration with industry and other regulators, harmonized standards Threats Inability to forecast vulnerabilities Unable to foresee gaps throughout product lifecycle Regulators Industry cannot inspect quality in Complacency in rapidly changing environment Has the Quality Icon Tripped or Fallen: Lessons Learned from an Auto Giant Is
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