Enhancing the Value of Manufacturing Systems

for Pharmaceutical Industries

Plant Solution Group
Manufacturing Practice

© Tata Consultancy Services ltd. 2 February 2005 1

 Introduction – TCS understanding

§ Current situation in Pharma industry is forcing manufacturers into a situation of

internal consolidation, discipline…Key questions
• How to increase production efficiency / flexibility
• How to increase the utilization of the current manufacturing IT
infrastructure in place?
• How to reduce cost of compliance, with increase / change in FDA
regulations?
• How to be competitive in drug manufacturing with the current market
trends?
§ This document shall briefly look into the current situation in Market, FDA
regulations and indicate offerings, addressing some of these

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 Pharma – Market Pressure

Economics & Technology Pressure Operational Pressure

§ Global competition
§ Industry consolidation (M&A)
§ Reduced margins
§ Highly fragmented market
§ Time to market
§ Reduce regulatory compliance cost / time
§ Production efficiency
• High Capacity Utilization
• Manufacturing/Process excellence

§ Changing Healthcare patterns • Engineering Efficiency

§ High regulatory compliance • Enterprise Efficiency

• Consistent Product Quality
§ High cost and time - R&D (NPI) § Sourcing cost and efficiency

IT has a significant impact on each of these business drivers

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 Pharma – Key Drivers

§ Time-to-market : Enable information flow across the chain and constantly

evaluate the active constraints to ensure optimal flow of material, improve
order fulfillment / schedule adherence
§ Production efficiency : Facilitate feed-forward and feedback to automate
decision processes based on data where possible
§ Regulatory compliance : Adherence to cGXP Quality standards to ensure
product and process quality
• Increasing compliance effectiveness
• Reducing compliance cost and risk

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 Pharma @ TCS

Global Life Science and Health Care Practice

Drug Development Clinical Trials New Drug Application Drug Manufacturing

GLP GCP NDA GMP

Manufacturing Practice - PSG

Delivery

GLP

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 Manufacturing Practice
Aligned to leverage domain knowledge
§ Business Consulting Group
• Design Process Optimization
• Supply chain optimization
• Production optimization
• Enterprise asset management
§ Plant Solutions Group
• Advanced process control and optimization
solutions
• Manufacturing Execution Systems (MES)
• System integration – Manufacturing Floor
systems
Focus
§ IT powered business solutions
§ Leverage TCS software development expertise to
provide best of breed services and solutions
§ Industry specific
• Domain and technology consulting
• Research and development
• Products / point solutions
Advantages
§ Industry focused solutions backed by rich domain
experience
§ Tools and components for high quality rapid
application development
§ Global delivery and support channels
§ Offshore development of modular and scalable
solutions
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 Integrated Enterprise

Level Info. Systems Time Scale The ‘traditional’

domain of information
technology
Databases Days to weeks maps only
4 ERP / SCM Applications Interface the business systems

Tight integration of
Historians DB Minutes to hours
3 production and
MES Applications Middleware

Flow of Information
business models
will unleash
Supervisory Control Seconds to maximum efficiency
2 SCADA
& Optimization PC based systems minutes

IT solutions
PLC, DCS Milliseconds to must span the
1 Automation &
Soft sensor seconds entire
Control
information chain of
the enterprise.
0 Sensing & Sensors Continuous
Monitoring Actuators Field devices

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Organization of Domain – Plant Solutions Group

SCM ERP CRM DKM CPM

Enterprise System
Enterprise Application Integration - EAI
Business
Object Solution Exchange
Model Information Group

Detailed Maintenance
Production Management
Product Workflow Performance Quality
Scheduling Management PSGTracking
- Manufacturing Enterprise System (MES)Analysis
Automation Management

Manufacturing Enterprise System Layer

Production Management
SCADA Historian
PSG
Transaction – Process Optimization
Process Optimization
Manager

Control Network
Plant Floor Control
PSG - Control System Integration

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 TCS – PSG Offerings

Integrated Production Monitoring System (IPMS)

Complete system design, development, implementation & support in providing
Integrated Production Management systems (IPMS) for bulk drug & formulation
manufacturing.
Our Offerings:
§ Integrated information flow across ERP / Planning system, SCADA and
PLC / DCS systems
§ Process Management
§ Batch Tracking / Lot Tracking
§ Performance analysis
§ Resource Utilization
§ Quality Management systems

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 TCS – PSG Offerings

Regulatory Compliance Services

Validation of Computerized / Control Systems and Processes in Pharmaceuticals,
Biotech, Healthcare & CPG industries

§ 21 CFR Part 11
§ HACCP
§ Quality Systems
§ Document Management and Control
§ Configuration Management & Change Control
§ Electronic Batch Record Systems
§ Lot Tracking and Genealogy
§ Ongoing “Compliance Assurance” Programs

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 TCS – PSG Offerings

Regulatory Compliance Services

Offering Services
§ Audits of existing computerized / control systems.
Auditing § Periodic audits for ongoing evaluation.

§ Analysis of audit information and system assessment versus regulations

Assessment & Analysis
to generate a gap analysis and provide recommendations for remediation
§ Implementation of solutions to address recommendations for compliance
Remediation
§- Remediation Plans, SOP’s

§ Validation Master Plan

§ Validation Project Plan
Validation of Systems
§ SRS / Installation Qualification (IQ)
§ FRS / Operational Qualification (OQ)
§ URS / Performance Qualification (PQ)
§ Traceability Matrix / Test Cases
§ Qualification Summary Report
Training § Training on validation of computerized / control systems

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 TCS – PSG Offerings

Production Scheduling
Challenges Solution
§ Sudden change in demand § Capacity Centric scheduling base on
§ Finite availability of manufacturing resources
§ High product mix - SKUs § Machine / people / tools / business rules
§ Real time manufacturing constraints
§ Loss of sale – Schedule adherence
§ Visibility into plant floor operation

§ Stringent regulatory compliance requirement § Simulation – “What if” analysis

§ Complex material flow
§ Complex Business rules for Pharma
manufacturing
§ Dynamically balance capacity & demand
§ Quick & effective reaction to sudden demand
changes
§ Integration with Planning System –
§ SCM/ERP

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 TCS – PSG Offerings

Process Optimization (PO)

PO solutions are based on state of the art advanced control, optimization and plant
management systems (for fermentation, reactors, decanters etc), that help plants
achieve higher levels of throughput, product quality and production efficiency for bulk
drug manufacturing.
Offerings and solution areas:
§ Advance Process Control
§ Process modeling & simulation
§ Real - time optimization
§ Conditional monitoring
§ Fault diagnosis
§ Soft sensors
§ Training
§ ROI analysis for advance control

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 TCS – PSG Offerings

Laboratory Information Management System (LIMS)

§ Implementation

§ Maintenance & support

§ Integration of LIMS systems with MES / ERP / SCM

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 TCS – PSG Offerings

Warehouse Management System

§ Goods Receipt identification and marking, storage location suggestion, partial shipments,
assignments, goods receipt inspection
§ Goods Issue - out booking of raw materials and finished products, delivery notes/shipping documents
§ Online material identification - description and status
§ Blocking and release of load carriers
§ Online booking and outbooking - actual consumption
§ Master Data suppliers, load carriers/load carrier type, storage locations/storage location type
§ Inventory Management
§ Relocation - storage area/load carrier status, transfers, container history, buffer management,
processing progress recording for materials
§ Load Carriers
management of load carriers - monitoring of releases - printing of labels

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Value Proposition – Pharma Manufacturing

Regulatory compliance & Production efficiency improvement

Commercial Bulk Drug Formulation Warehouse &

Production manufacturing manufacturing Distribution

Quickly achieve Improve Quality Improve scheduling Warehouse

& re-scheduling management
regulatory Minimize waste system
Batch tracking /
compliance Improve yield Warehouse
genealogy
automation using
Electronic Batch
Electronic Increase flexibility RFID’s / Barcode
Report
submissions Electronic batch Improve order
Improve schedule fulfillment /
recording
Reduce risks and execution schedule
Performance adherence
total cost of Increase flexibility
analysis
Improve schedule
compliance Batch Tracking execution

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 Project Methodology

Optimizing individual processes in isolation simply shifts the inefficiencies to other

processes, rather than eliminating them from the system…

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 Project Methodology

TCS Expertise
§ Industry focused solutions backed by rich domain experience
§ Functional expertise
§ IT expertise in manufacturing and business systems
§ Mature development processes
§ ‘Large Project Management’ skills for geographically spread project
§ Large and Mobile resource pool for running multiple projects, across the world,
in parallel
§ Ability to Ramp-Up rapidly

… keystones to deliver

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 Case Study # Pharma Major in US

Warehouse Management System

§ Reduce risks and total cost of compliance of computer & control

system validation
§ Choosing a common partner for both Control system & computer

system for managing compliance program

Warehouse Management System

§ Validation of PLC / DCS / SCADA / HMI systems Management
of Compliance Program
§ Gathering User requirements, generation of system design / code

review (PLC / SCADA) / test cases, testing, generation of validation

report

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 Case Study # Pharma Major in US

Business Challenges Technology

§ Regulatory Compliance - FDA § Allen Bradley PLC / SLC / PV /
Barcode scanners
§ Batch / Production Tracking
§ RS SQL, RS DATA
§ Visibility in Work-in Progress (WIP) § MS SQL Database
§ HVAC control § Tracking applications using VC++

Solution Team Experience

§ Integrated Production Monitoring system
§ Integration MRP II & SCADA / PLC automation systems for data
integration
§ Batch Tracking for the formulation plant using Barcode
§ Electronic production reports for regulatory compliance
§ Performance analysis for critical resources
§ MIS Reports
§ HVAC system automation / Machine controls

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 Case Study # Medical Devices major in US
Business Challenges
Business Challenges Benefits
§ Reducing the Time spent of inspection.
§ Minimizing the error in Inspection. § Reducing the Time spent for inspection.
§ Real Time inspection data collection.
§ Minimizing the error in Inspection.
§ Grading the supplier according to the inspection
results.
§ Real Time inspection data collection.
§ Reducing the Re-inspection.

Solution
ERP

Order Information
§ Seamless interfaces were built for: Accepted Part Rejected Part
Information Information
• Receiving Inspection Instruction Sheet information (IIS) from
PDM
• system to MES. MES

• Receiving the Lot information from ERP layer to MES and Receiving
Inspection
MRB

updating the results back to ERP.

§ Latest Display of Instruction sheets & Lot details at Inspection area
Inspection Sheet (IIS)
§ Information of Inspection results to PDM / ERP systems
§ Vendor rating based on inspection reports and history PDM

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 Case Study # Global Plastic Manufacturer

Business
BusinessChallenges
Challenges Technology
§ Multi-plant requirements, single standardized solution § Aspen Manufacturing Suite
(China, Thailand, Australia and Korea)
§ Lot tracking § GEMMS – Oracle Based ERP
§ Objective – paperless from Recipe Management to TTFG
Customer Speak
§ Complex Recycle additions to be digitized
§ Bar Code and Serial Communications

§ Disparate systems- ERP, Plant Control Systems,Weighing § Microsoft Client – Server (COM/DCOM)
“Thanks to TCS team, we are now live with MES at our
scales § ODBC, RDBMS
plants
§ Change management in Asia-Pacific. I want to take this opportunity
to thank the TCS team for staying focused…
Solution
§ Theirand
Detailed study commitment
documentation & oftechnical ability
unique and has been
standardized requirements
exemplary.
for each plant
§ Barcode, RF scanners used for weighing and dispensing
Look forward to more success stories in the future.”
§ Standardization of MES solution architecture & integration with external
systems for different plants
§ Seamless integration of information from download of batch ticket to upload
… Client Asia-Pacific IT leader
of lot closure details, including recycle additions
§Training

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 Our Experience

Picture Tube Manufacturer, India Auto Component Major, US

§ Design, Development & implementation of IPMS § Detail Scheduling system - Design, Development

system with Product tracking and Implementation

§ Real time data integration across SCM using

§ Quality Management by integrating QC / testing

TIBCO EAI frameworks

equipments with MES system
§ Optimization at every "node" - from Inventory
§ Real time data integration of shop floor
leveling to Vendor Scheduling

controllers – AB, Mitsubishi, Siemens, Omron § The production planning module was custom

§ Comprehensive visibility in WIP for customers built

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Discussion….

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