1. Desarrollo según ICH Q8 y sistemas de calidad asociados. Gestión del conocimiento. Alicia Tébar Sevilla, 28 de octubre de 2011 XX Jornadas de la SEGCIB

3. Objetivo de una compañía farmacéutica Approved product on the market Product Realization State of Control Continual Improvement ICH Q10 Late-stage clinical trials Early-stage clinical trials Develop a Clinical Process Commercial Process Calidad y compliance OK Reducir costes de manufacturing e inspección Animal studies

5. Desarrollo y Producción un solo equipo Late-stage clinical trials Approved product on the market Early-stage clinical trials Information to Design for Manufacturing Develop & Transfer a Process & Design Space Develop a Clinical Process Commercial Process © 2007, Aegis Analytical Corporation Animal studies Compliance Stringency Supply Supply Develop mid-scale process Develop large-scale process Supply Develop commercial-scale process Supply Supply Operate an approved commercial manufacturing process Start-up commercial process Discover lead compound Develop small-scale process Supply Economic Stringency Consultation, Submission & Approval Process Updates, Inspections & Enforcement

6. Realización vs. Quality “ Quality is a side effect of a system that is running well” Integrated Quality / Sustainable Quality Quality by Design Quality in Execution Quality through Monitoring Products Quality Systems Manufacturing Patient Safety Surveillance Process & Product Development Influence the design of new solutions Continuously improve products Influence the design of new systems Continuously improve processes Quality by Design Quality in Execution Quality through Monitoring Control Auditing Systems Integrated Quality. Continuous Improvement.

7. Quality: Modelo ICH Q10 Básico: En un sistema basado en calidad por diseño hay que llevar la calidad al desarrollo En vigor desde el 2008

9. Pharmaceutical Quality Systems Elements Development Tech Transfer Discontinue Commercial Supply Monitoring Systems CAPA Systems Management Review Change Management GMP

15. P Q S Elements+Enablers Development Tech Transfer Discontinue Commercial Supply Monitoring Systems CAPA Systems Management Review Change Management Quality Risk Management Knowledge Management GMP

16. El imprescindible Sin datos no podemos extraer la información para tomar las decisiones correctas.

17. Facilitadores. Análisis de riesgos ICH Quality Implementation Working Group - Integrated Implementation Training Workshop Initial QRA PHA FMEA FMEA FMEA API Crystallization Blending Lubrication Compression API PSD Lubricant Lubrication time Hardness Content uniformity Beginning Design Space Control strategy Blending time Lubricant amount Lubrication time Pressure Tablet weight API PSD model Blending time Feedback control Mg stearate SSA Lubrication time Pressure Automated Weight control Blend homogeneity High Risk Medium Risk Low Risk API PSD

18. Facilitadores. Gestión del conocimiento Christopher Sinko, Ph.D. Pfizer Global Research & Development Integrity Uniformity Weight Control In vitro Dissolution Chemical Purity API, Excipients, Manufacturing Process Pharmaceutics Profile API Particle Size API Salt Selection Chemical Compatibility Degradation Pathway Prediction Material Property Characterization Process Simulation Design

24. Gestión del conocimiento

28. Process intelligence Risk analysis Lean Six Sigma Diseño de experimentos Análisis y control avanzado de procesos MVDA Plataformas de software integradas para realizar todas las fases que requiere un desarrollo basado en el diseño, la transferencia a producción y el mantenimiento y la mejora continua. Quality by Design: Tools and Platforms for Whole Process Analysis Throughout Process/Product Lifecycle J. Machado et al. 4TUNE Engineering Ltd Ponencia presentada IFPAC 2011

29. Tu calidad es nuestro compromiso innovación – experiencia – conocimiento – capacidad organizativa Vía Augusta 59, Edificio Mercuri | E-08006 Barcelona Tel. +34 932 377 555 | Fax +34 932 174 919 Soluciones innovadoras para la industria farmacéutica Gracias por su atención