Validaciones

Nueva Estrategia de Validación de Procesos Johnny E. Aguilar
Manufacturing Science & Technology Manager
Novartis Farmacéutica – España BCN 10-Dec-2009

Nueva estrategia de Validación de procesos
Agenda

Situación Actual y Situación Futura Entorno Regulatorio Previo Nueva estrategia de Validación de Procesos
• Diseño del Proceso • Calificación del Proceso • Verificación continua delProceso

Reacciones de la Industria Conclusiones Finales
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Estrategia Actual

‘‘ Process validation is establishing documented evidence which produces a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and quality characteristics’’GUIDELINE ON GENERAL PRINCIPLES OF PROCESS VALIDATION MAY, 1987 FDA

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Validación de Procesos: Situación 1987

4 | Nueva Validacion Proceso | Johnny Aguilar | Date | Subject | MS&T Novartis

Estrategia Propuesta
“ The collection and evaluation of data, from the process design stage throughout production, whichestablishes scientific evidence that a process is capable of consistently delivering quality products”
New GUIDELINE ON GENERAL PRINCIPLES OF PROCESS VALIDATION 2008 FDA

The text includes elements of the FDA Initiative cGMPs for the 21st Century (i.e. risk management, quality management tools) as well as the concept product lifecycle, which is as well connected to ICH Q8, Q9 and Q10 guidelines
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ENTORNO REGULATORIO PREVIO
Johnny E. Aguilar
Manufacturing Science & Technology Manager
LBH589 Project Leader Novartis Farmacéutica – España

“Un Paradigma en crisis”

Main points from this:
• High tech in R & D • Relatively low tech in Manufacturing • It matters

Big Pharma manufacturing costs are $ 90 BnSignificantly more than R&D

Quality by Design: A Challenge to the Pharma Industry

(CAMP, R. Scherzer. FDA Sci. Board. 4/9/02)

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Que es erróneo dentro de la Industria Farmacéutica Cualquier cambio es malo Garantia de Calidad por producto acabado Blind Compliance not Science No mejora continua Calidad basado enevidencia documental (calidad vía inspección)
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Enfoque de las nuevas ICH
Product quality and performance achieved and assured by design of effective and efficient manufacturing processes Product specifications based on mechanistic understanding of how formulation and process factors impact product performance Anability to effect Continuous Improvement and Continuous "real time" assurance of quality

ICH Meeting Brussels 2003
The new Paradigm
Pharmaceutical Development (Q8)
Present: Knowledge transfer / Science Consistent output based /

Quality Risk Management (Q9)
Present: Opportunity to use structured process thinking

Pharmaceutical Quality Systems (Q10)

Q8 Q9 Q10

Future:

QualitySystems across product life cycle

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Parte 1 Diseño del Proceso Johnny E. Aguilar
Manufacturing Science & Technology Manager
Novartis Farmacéutica – España

DESARROLLO DE MEDICAMENTOS
D3 CSP sPOC ISA POC Ph IIa readout Ph IIbreadout Ph. III readout Sub Launch

Development Activities

sPOC
CSP Dev Assess P1 CSF P1 resupply MF /FMI feas

DDP

FDP
Prototype Optimization FMI Lab /Pilot

SDP
Launch/Validation/ Confirmation FMI Validation FMI Pre-Validation FMI Confirmation

Prot. Adequate

Peer Reviews

Analy Challenge 1

Quality Review 1

Analy Challenge 2

Quality Review 2

Quality Review 3

CSP...