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KICKOFF SIG ISPE 4.0 WORKING GROUP ISPE SPAIN
Alicia Tébar
2 de Julio 2019
IQS Barcelona
ispe.orgConnecting Pharmaceutical Knowledge
What Is PHARMA 4.0?
Pharma 4.0 is the digitalized operations model of a pharmaceutical organization
“A maximally efficient, agile, flexible pharmaceutical manufacturing sector
that reliably produces high-quality drugs without extensive regulatory oversight.” Dr.
Janet Woodcock FDA 2005
PHARMA 4.0 = DIGITALIZATION + ICH Q10
PHARMA 4.0 Hype or Reality?
PE SPECIAL REPORT 2018 EUROPE ANNUAL CONFERENCE
ispe.orgConnecting Pharmaceutical Knowledge
la industria 4.0 integra tecnologías disruptivas como el IoT, BigData,
impresión 3D, realidad aumentada, simulaciones, realidad virtual, robótica
avanzada e inteligencia artificial,
• El nivel físico, o de tecnologías hardware inteligentes, como puede
ser el aplicar robótica avanzada, la internet de las cosas, las
impresoras 3D, etc.
• El nivel de automatización de procesos físicos donde aplicar la
sistematización, monitorización, trazabilidad, simulaciones, realidad
aumentada, etc.
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What Is PHARMA 4.0?
ispe.orgConnecting Pharmaceutical Knowledge
la industria 4.0 integra tecnologías disruptivas como el IoT, BigData,
impresión 3D, realidad aumentada, simulaciones, realidad virtual, robótica
avanzada y drones, inteligencia artificial,
• El nivel de automatización de procesos lógicos, como puede ser la
implantación de soluciones BPM , sistemas MES o BI, CRM……
• El nivel de inteligencia distribuida donde utilizar la información de
todo lo que pasa dentro y fuera de las fábricas, crear modelos
predictivos y aplicar machine learning, integrar sistemas en el
cloud……
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What Is PHARMA 4.0?
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ENABLER 1: DIGITAL MATURITY
Digital maturity is the first enabler in the change to a data-driven, agile
organization: paperless execution systems, virtual reality (VR),
augmented reality, collaborative robotics, 3D printing, blockchain………
Level 1 Computerizacion: Simplificar tareas repetitivas
Level 2 Conectividad: integración de sistemas
Level 3 Visibilidad: Construir una “Ventana” de información en
tiempo real
Level 4 Transparencia: Data analytics para entender los efectos
Level 5 Predictabilidad: Capacidad de similar escenarios futuros
Level 6 Adaptabilidad: El Sistema se “autocontrola” y se adapta
anuevas situaciones (IA).
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ENABLER 2: DATA INTEGRITY BY DESIGN
Data will travel in all directions of the value network;
governing its integrity will pose new challenges: data flow
charts linked to process flow charts.
To bring IT into an organization, you must have defined
processes and data flows. This starts with the
implementation of the enterprise resource planning (ERP)
system
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Elements of PHARMA 4.0
• New process validation guidances empower continuous
improvement.
• Data interfaces, process automation to support continuous
process verification (CPV) by applying technologies like
PAT, and predictive process controls to establish real-time
release testing.
• Some big pharma companies have established a “data
lake” that also serves as “one source” for system integration
as well as fast real-time and ad hoc reporting.
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PROCESS VALIDATION 4.0
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Elements of PHARMA 4.0
• Organization and processes
• the concept of quality assurance must be adapted to cross-
functional business processes.
• the tasks and responsibilities of systems, cross-functional
process owners, and content owners must be redefined.
• Culture
• Implementing Pharma 4.0 and the holistic control strategy
uses the holistic approach to design and execute the
business processes and to bring automation and paperless
execution to the shop floor. This requires a culture of
collaboration for all business units
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Collaboration to create a HPCS
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PHARMA 4.0 = DIGITALIZATION + ICH Q10
Process Analytical Technology (PAT), essential in highly automated
environments, further enables advanced technologies like continuous
manufacturing.
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HPCS implementation
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GRUPOS DE TRABAJO EN TORNO A PHARMA 4.0
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GRUPOS DE TRABAJO EN TORNO A PHARMA 4.0
ispe.orgConnecting Pharmaceutical Knowledge
• Reuniones para tratar un tema específico
• Compartir experiencias de implementación: NETWORKING
• Participar en jornadas y eventos
• Publicar un articulo en PE
• Escribir una Guía con recomendaciones
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OBJETIVOS DEL GRUPO DE TRABAJO
ISPE European Conference 2020 en Madrid
30 March - 1 April
