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Future of Pharma Manufacturing BCG Ipa Cobranded PDF
Future of Pharma Manufacturing BCG Ipa Cobranded PDF
MANUFACTURING
HOW DIGITAL COULD TRANSFORM PHARMA MANUFACTURING
IN FUTURE
By Rahul Guha, Kshitij Vijayvargiya, Mustafa Rangwala and Anang Swapnesh
EXHIBIT 1 | Future of Work Thinking Around 5 Core Operating Pillars for Manufacturing
2
Process
simplification
1 3
Asset
Data
performance &
acquisition
Automation
& analytics
FUTURE OF
MANUFACTURING
5 4
People org of
Control tower
the Future
Step-jump in capability
• Predictive analytics • Control logic driven • Real time perf. • Operators handling • Organization level
& synchronous process operations simulations exceptions E2E optimization
Level 3 feedback loops • QC built into process • Integrated QC with
(Predictive Manufacturing
systems)
• Descriptive data • Harmonized • Condition based • Operators taking • Site level E2E
analytics processes across optimization data based decisions optimization
network • Integrated lines • Remote working for • KPIs beyond output
Level 2 • Profile driven ops support teams (e.g.: energy,
(Integrated • Error proofing using sustainability)
Outcomes) digital
• Deploying and leveraging analytics talent Exhibit 5 provides an example where ma-
towards building optimization logic chine learning is leveraged to pre-empt the
occurrence of breakdown and trigger re-
• Strengthening shop floor organization quired maintenance
towards data-based decision making.
Autonomous operating teams. in the Exhibit 6 provides an example of a Digital
organization could become the norm, twin solution in context of Pharma plant.
with end to end responsibility of This creates a virtual representation of
outcomes from an area given to a team plant’s assets and processes through statis-
tical and physical models and could be
• Remote working could also be enabled used towards decision making through real
for non-shop floor functions by leverag- time scenario creations. Digital Twin is of-
ing the digital data. Functions like ten used towards decisions such as:
supply planning, QA, document review
etc. could be served through a remote • Equipment utilization and capex
shared service set up across sites planning
Client context:
Increase cycle time variation due to minor stops and speed variation for a vial filling line for an Indian PharmaCO
Washing
Vial and stopper dimensions and preventive maintenance are the two major
infeed Quarterly < 45 days
themes driving cycle time
conveyor
Theme Variable measure Variable
Vial Monthly/
Vial Dim. Average Overflow capacity 80.4 filling and Half-yearly/ < 19 days
Vial Dim. Average Weight 69.7 stoppering Annual
Client context:
Injectable formulation site of global pharma manufacturer with frequent breakdown on heating tunnel of filling line
Tree 3 Combined
Classifier random
70 Derived forest model to predict Predicted machine
features from breakdowns breakdowns at with 50–75%
tunnel sensor accuracy
data Tree 200 Separate models prepared for
prediction windows of 2, 4, 12
Ensemble of and 24 hours
decision trees
OUTPUTS
1 Top 3 features for breakdown prediction Prediction used by
• Average of Cooling Zone 1 airflow in past 2 hours engineering team to reduce
• Max make up zone 1 airflow in past 2 hours instances of breakdown by
• Deviation in Cooling Zone 1 airflow in past 4 hours 50%
Maintenance team
receives (in real-time)
DIGITAL ASSET SOLUTIONS SMART 3D PLATFORM instructions and
Twin conducts rectifications
Issue solved
Flow of information
Use case in action
E2E Visibility
EM/Plant Scheduling Inventory Planning Customer Service
Control tower integrate data from across the supply chain to provide E2E visibility
3
1 2
Distributor
Raw Mat. Distribution GPO/IDN
Suppliers Manufacturing Consumer
and Logistics
Transport Pharmacy chain
Transport
As companies transition to “Lights Out” on the maturity grid, at a site level. Setting
plants / section, workforce will be trans- the aspiration depends on the digital start-
formed into a lean organization of dedicat- ing point of a plant, and the strategic ob-
ed technical and digital experts (for exam- jectives in medium term. For example, a
ple, process scientists) legacy First Generation site could aim to
reach level 2 and attempt level 3. While for
Companies will also initiate data integra- a Next Gen plant, the aim should be to
tions with suppliers and customers that reach level 3 and strive for level 4 in cer-
would allow real time decisions for the tain sections.
overall ecosystem.
Such a journey could drive significant im-
provement in manpower productivity,
Digital Use Cases Along The yield, OEE, OTIF, deviations per batch and
Maturity Framework conversion cost outcomes. While the exact
In this journey, different digital use cases impact would be different for different
would need to come together at different sites considering the starting point, a typi-
levels to drive integrated outcomes. An il- cal magnitude of impact is laid out in Ex-
lustrative set of such use cases is laid out in hibit 9.
Exhibit 8
A full scale journey towards building the
future manufacturing function could be a
Roadmap and Impact 2+ year process. As a starting point, compa-
Globally, many organizations have em- nies should conduct a maturity assessment
barked on small scale pilots of different of their sites to identify current technical
use cases in different parts of their net- capability and lay out strategic objectives
works. Their experience suggests that it is and aspirations on the maturity grid. Sub-
crucial to upfront set-up a right aspiration sequent to the assessment, a more detailed
Step-jump in capability
• Parametric control and • Parametric process • Continuous process – e.g. • Remote operations – • Org wide Control Tower
feedback control and real time coaters Digital Ops Command • Real time optimization for
• Real time PAT quality feedback • Integrated pkg / filling lines Room EBITDA vs sales
• Process robustness – • Exception based review • Suite simulator • Integrated Quality with
CPP range and Manufacturing
Level 3 parameters
• Analytics data lake • AI golden batch profile • Run time efficiency & minor • Dynamic crew scheduler • Digital Twin
• Full data integration - • AI assisted cycle time stop elimination • Remote work (selective • Dynamic site scheduler
LIMS, MES, Historian, optimization • Predictive maintenance operations) • Integrated control tower
ERP, SCADA etc. • Google of investigations • AI Breakdown assist • Multi-suite deployment of • Indirect cost optimizer
• Outcome predictor • Error proofing enabled by • Process automation – e.g., operators • Consumables
Level 2 video/ digital monitoring material transfer, sampling • Remote Shared Services • Spare parts
• AR instructions • COBOTS for maintenance, – Support functions • Utilities
• Unified work templates cleaning etc. • Inventory
• Foundation data • Optimal Standard work • Local OEE optimization • Resource matrix model • Functional dashboards
systems: E-logbook, E- • Role cards (incl digital) • Base automation: GMP • Shift deployment tool • Local Granular scheduler
BMR, LIMS for critical processes washer, hydraulic lifts • Safe-at-work norms • Remote enabled shopfloor
• BMR free of manual • Trigger based maintenance • Gamified multi-skilling Gemba
Level 1 entry
EXHIBIT 9 | Basis our Experience, We Expect Significant Impact Potential Through this Journey
LEVEL 1:
DEPLOY BASE SYSTEMS LEVEL 2 LEVEL 3 LEVEL 4
Acknowledgements
The authors thank IPA Executive Council and all member companies for their valuable contributions.
The authors also thank Vikash Agarwalla (MD & Partner, Gurgaon); Roberta Mckee (Senior Advisor, BCG);
Frank Cordes (MD & Partner, BCG) and Daniel Kuepper (MD & Partner, BCG) for their valuable inputs and
guidance to design the future of manufacturing function. Jamshed Daruwalla, Pradeep Hire and Ratna
Soni are also thanked for their support in the editing and formatting of the article.
Indian Pharmaceutical Alliance (IPA) represents 25 research based national pharmaceutical companies.
Collectively, IPA companies account for over 85 percent of the private sector investment in pharmaceuti¬-
cal research and development. They contribute more than 80 percent of the country’s exports of drugs
and pharmaceuticals and service over 57 percent of the domestic market. For more details please refer
www.ipa-india.org
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