Team IIMB

Arka Mal
Saurav Paikrao
Omkar korke
Pharma 4.0, KPIs & Assessment of organizational Maturity in Pharma 4.0
Pharma 4.0 : An umbrella term for the adoption and implementation of digital technologies and strategies tailored to the unique context of pharmaceutical manufacturing.

Fig.1: 5 Core Operating Pillars

for Manufacturing

Fig.2: 4-Step Journey for

Achieving the "Future in
Manufacturing”
Fig.3: 4-Step Journey towards global competitiveness

Operational Innovation and

KPIs Categorization Quality and Compliance Patient-Centric Metrics
Digital Integration Efficiency Development

Metrics that track KPIs that measure

Emphasis on the Metrics that
What does the KPI the development KPIs that ensure the impact of
integration of digital measure the and launch of new products meet the Pharma 4.0 on
mean? technologies into efficiency and products using highest standards patient outcomes
the manufacturing effectiveness of the digital tools and comply with and satisfaction.
process manufacturing regulations
process
Time to market, Patient satisfaction
IoT connectivity, Quality control pass
number of new with digital health
real-time data OEE, cycle time rate, product recalls,
products launched, tools, personalized
KPIs analysis, AI/ML reduction, predictive regulatory
revenue from new medicine product
model deployment maintenance. compliance rating.
products development.

• To measure and monitor the effectiveness of Pharma 4.0 initiatives

Objective: • To ensure alignment with strategic goals and drive continuous improvement
 Technologies driving the Transition to Pharma 4.0
Adaptive Robotics
These can be used to automate
tasks in the pharmaceutical process,
such as picking & placing products,
assembling devices, and
performing Quality Controls
Cloud Technology
Cloud technology helps
pharmaceutical companies store,
manage, and analyze vast data to
support drug discovery, clinical
trials, and manufacturing.
Embedded System &
Cyber Security
Embedded systems are used in
a variety of pharmaceutical
devices, such as medical
imaging machines, drug
delivery systems, and
laboratory equipment
Data Analytics & AI
Data analytics and AI help
pharmaceutical companies extract
insights from data and use
predictive models to improve
efficiency, quality, and patient care
Adaptive Manuf.&
Virtualisation of tech.
These can be used to create
flexible and agile pharmaceutical
manufacturing processes and
allow to quickly adjust
production lines
Communication &
Networking
These technologies enable
real-time data sharing and
collaboration, which is critical
for efficient and effective
operations in the pharma
industry
Case Study: GSK's Continuous Manufacturing Approach
• Title: "GSK's Leap into Continuous Manufacturing with Real-time Data"
• Background: GSK (GlaxoSmithKline) is a global pharmaceutical company known for its innovative
approaches in drug development and manufacturing.
• Challenge: The need to enhance manufacturing efficiency, reduce downtimes, and ensure
consistent product quality.
• Solution: GSK adopted a continuous manufacturing approach, integrating real-time data
collection and analysis.
• Results: The real-time data allowed GSK to quickly identify trends, adapt to specific condition
changes, and optimize manufacturing processes.
• Key Takeaways and Tech used Embracing real-time data and continuous manufacturing can significantly
enhance efficiency and product consistency in the pharmaceutical industry.
Communication &
Adaptive Manufacturing Data Analytics & AI
Networking
Case Study: Lassila M's Pharma 4.0 Implementation
• Title: "Harnessing Pharma 4.0 for Optimal Batch Classification"
• Background: The study by Lassila M (2020) delves into the potential of Pharma 4.0 in the pharmaceutical
sector.
• Challenge: Addressing challenges such as risk reduction, manufacturing difficulties, and comprehensive
batch analysis.
• Solution: The study emphasized the use of Cyber-Physical Systems (CPS) to integrate the physical and
digital worlds. AI was highlighted as a tool for researching new medications and for batch classification.
• Results: The integration of AI and CPS led to automation, reduced human interventions, and increased
efficiency. Advanced analytics were applied across various areas, including R&D, safety, manufacturing,
and the supply chain.
• Key Takeaways and Tech used:: Integrating advanced technologies like AI and CPS in the pharmaceutical sector
can lead to enhanced quality control, reduced risks, and optimized manufacturing processes.
Data Analytics & AI Adaptive Robotics
 Appendix A: Detailed KPI Metrics
Innovation and Development KPIs:
• Time to Market for New Products with Digital R&D:
Measures the speed of product development
using digital tools.
• Number of New Products Launched Using Digital
R&D: Reflects the innovation rate in a digital
environment.
• Percentage of Revenue from Products Developed
Using Digital Tools: Indicates the financial
impact of digital innovation.
Operational Efficiency KPIs:
• Overall Equipment Effectiveness (OEE) with Digital
Integration: Traditional OEE enhanced with digital
metrics like real-time monitoring and predictive
maintenance.
• Cycle Time Reduction Attributed to Digital Optimization:
Measures the efficiency gains from digital
integration.
• First-pass Yield Improvement with Digital Oversight:
Evaluates the quality improvements due to digital
monitoring.
Quality and Compliance KPIs in a Digital Context:
• Percentage of Products Passing Quality Control with Digital • Percentage of Manufacturing Processes Connected to IoT:
Monitoring: Reflects the enhancement in quality due to
digital oversight.
• Number of Product Recalls After Digital Integration: A
measure of quality and safety in the Pharma 4.0
context.
• Regulatory Compliance Rating with Digital Record Keeping:
Evaluates the effectiveness of digital tools in ensuring
compliance.
Patient-Centric KPIs in Pharma 4.0:
• Percentage of Patients Using Personalized Medicine Products
Developed Through Digital R&D: Measures the market
adoption of personalized products developed using
digital tools.
• Patient Satisfaction with Digital Health Tools and Services:
Evaluates the effectiveness of digital health tools from
the patient's perspective.
Digital Integration KPIs:
Measures the extent of IoT integration in the
manufacturing process.
• Percentage of Data Analyzed in Real-time: Indicates the
immediacy of data processing and the potential for
real-time decision-making.
• Number of AI/ML Models Deployed in Manufacturing: A
direct measure of the adoption of advanced analytics
in the manufacturing process.
• Percentage of Production Schedules Optimized Using Predictive
Analytics: Reflects the use of data-driven insights in
production planning.
• Number of Quality Issues Predicted and Prevented Through
Analytics: Demonstrates the proactive use of data to
enhance quality.
• Number of Unplanned Downtime Events Avoided Through
Predictive Maintenance: Highlights the benefits of
predictive analytics in equipment maintenance.
Key Features

Digital Integration Real-time Data Analysis Advanced Analytics Connected Health

Seamless integration of Immediate processing and Use of AI and ML for Integration of patient data & feedback into
physical and digital utilization of data for decision- predictive analysis, quality drug development & manufacturing process
systems making. control, and R&D
Significance

Efficiency Quality Innovation Regulatory Compliance

Streamlined ops, less Enhanced product quality through Faster R&D cycles and Digital tools to ensure and
downtimes, optimized real-time monitoring and personalized medicine demonstrate compliance with
production schedules predictive analytics development global standards
Challenges

IT/OT Convergence: Change Management Ensuring Cybersecurity

Bridging the gap between Information smooth transitions and Protecting sensitive data and
Technology (IT) and Operational Technology employee buy-in systems from threats.
(OT)
Appendix C: Technology Deepdive
Benefits of Pharma 4.0
• Improved manufacturing efficiency and quality control: Pharma 4.0
technologies enable real-time monitoring and optimization of
manufacturing processes, which can lead to significant
improvements in efficiency and quality.
• Personalized medicine: Pharma 4.0 technologies can be used to
collect and analyze large amounts of patient data, which can
be used to develop personalized treatments tailored to
individual patients' needs.
• Improved supply chain management and patient safety: Pharma 4.0
technologies can be used to track and manage inventory and
distribution more effectively, and to ensure the safety and
authenticity of pharmaceutical products.

Challenges of Pharma 4.0:

• Significant investment: Pharma 4.0 technologies can be

expensive, and implementing them requires significant
investment in infrastructure, software, and talent.
• Organizational change: Pharma 4.0 requires significant changes
to the organizational structure and culture , which can be
difficult to achieve.
• Compliance: Pharma 4.0 technologies involve the use of
advanced systems and software. Ensuring compliance with
regulatory requirements is a significant challenge.
• Data privacy and security: Ensuring data privacy and security is a
major challenge, as the data is often sensitive and subject to
regulatory scrutiny.
Appendix D: Assumptions, References
Assumptions
• Technological Readiness: Pharmaceutical companies have the basic technological infrastructure in place to adopt and integrate Industry 4.0 technologies.
• Regulatory Compliance: Any implementation of Pharma 4.0 technologies will be done in compliance with local and international regulatory standards.
• Data Security: Pharmaceutical companies prioritize data security and have measures in place to protect sensitive information, especially when integrating new digital
technologies.
• Continuous Improvement: The adoption of Pharma 4.0 technologies is part of a continuous improvement process, and companies are open to iterative enhancements.
• Supply Chain Integration: The entire supply chain, from raw material suppliers to distributors, is considered in the Pharma 4.0 transformation.
• Financial Investment: Pharmaceutical companies are willing and able to invest in the necessary technologies and training to fully realize the benefits of Pharma 4.0.
• Patient-Centric Approach: The ultimate goal of Pharma 4.0 implementations is to benefit the end patient, whether through improved drug efficacy, reduced costs, or faster time-
to-market

References
• https://qbdgroup.com/en/blog/pharma-4-0-the-future-of-pharmaceutical-manufacturing/
• https://link.springer.com/article/10.1007/s11356-023-26856-y/tables/1
• https://www.migso-pcubed.com/case-studies/case-study-pharma-4-0-transformation-office/