Total Quality Management in Pharma Sector

TOTAL QUALITY
MANAGEMENT
IN
PHARMA SECTOR
Prepared By:
GAURAV THAKUR (92)
PREPARED FOR :Prof . RAJWADE SIR

Introduction
The pharmaceutical industry develops, produces, and
markets drugs licensed for use as medications.
It is a highly competitive non-assembled global industry.
Its was formed during the late nineteenth century
First this company started out as a Rhine –Based family

dyestuff & chemical Companies.
Over time many of these chemical companies moved into
the production of pharmaceuticals and other synthetic
chemicals and they gradually evolved into global players.
In 2006, the pharmaceutical industry was ranked the no. 1

most profitable industry on the fortune 500.
In the 2009 survey, , the pharmaceutical industry was

ranked third
Worldwide sales > $145 billion/year
US = Largest markets (40 % of worldwide sales)
8 out of 25 most profitable U.S. companies are

pharmaceutical companies
Few Facts of Indian Pharma
Industry
India's pharmaceutical industry is one of the
fastest growing sectors in Indian economy with
an average annual growth rate of 11 percent.
The industry is ranked fourth in the world in

terms of production volume and 13th in
domestic consumption value
The pharmaceutical industry in India meets

around 70% of the country's demand
The Indian Pharmaceutical sector is highly
fragmented with more than 20,000 registered
units.
250 large units and about 8000 Small Scale

Units, (including 5 Central Public Sector Units).
TOP TEN COMPANIES
Ranbaxy
Dr. Reddy’s Laboratories
Cipla
Sun Pharma
Lupin Laboratories
Aurobindo Pharma
Glaxo Smith Kline
Cadila
Aventis Pharma
IPCA
Managing batches at the press of a button
SAP system based on the 'Best Practice Pharmaceutical

Industry’
key business processes are mapped
product runs through various stages of the quality control process

(laboratory analysis production stage  final checks stage)
Verification of the active agent content.

Tracking via a batch tree
Maintaining Transparency
In-house logistics
Production and
Quality control
for example: when orders are received, to check which batches are available
in what quantities and with which properties.
Materials Management  Quality Management 

Production Planning modules
MUDA : Elements of Production that Add Time,
Effort, Cost, but no value
Transportation
Inventory
Overproduction
Processing
Intellect
MUDA
Motion
Rework
Waiting
Cellular Flow Concepts
 End to end operations.
 Continuous material movement, no in process storage.
 visibility of all operations, preferably on same floor.
 Each process should be pull system instead of conventional produce and
push system.
 In short only when one batch is completely produced next batch can be
taken.
 No in process quarantine.
 Inspection and QC are non Value added activities (so time taken for
inspection and quality control activities to be minimized).
 Any process is in trouble, rest of the resources pours in to solve it
immediately.
Eye opening results Parameter Old
Facility New Cellular Flow Facility
Manufacturing Volume 10-20 Million

100 Million
Value added time
(% Total Time) 15% 40%
Cycle Time
(Dispensing to Packing) 600 Hrs 80 Hrs
Distance Traveled by Batch

(Dispensing to Packing) 220 m 73 m
Distance traveled by QC Sample 600-

800 m 0 m
Yield 97.5% 99.6 %
Addressed MUDAs and Ripped gains
MUDA GAIN
Time
Reduction in non value added Time
Batch & QC Sample movement

reduced
Motion
Max One Batch Inventory at each

Inventory stage.
Reduction in waiting due to cellular

Waiting Flow
Reduction in Yield loss.

Loss
Learning
•Quarantines cover up problems and
inefficiencies
•Operational efficiency quality
•Material is KING and should move
constantly
•Simple solutions are more effective than
complex automations.
•Compact layouts result in lower operating
costs and better control
Pharmaceutical Manufacturing
(Long Before)
 Regulatory requirements, Compliance and Quality were TABOO

 Manufacturing Cost was fraction of Sales hence very little
significance of Efficiency
 Operational improvements were considered as compromise
with Quality
 Operational Excellence & Manufacturing Efficiency were NON
EXISTENT
 Past experiences became regulatory compulsions
“Rocks in the Water”
High Throughput Time (TPT)
Pharmaceutical Manufacturing
Changed Scenario
 Indian Pharma Industry entering the Global

Generics Market
 Contract Manufacturing becomes a big opportunity
 Operational Efficiency Critical for surviving

Globally
LEAN Manufacturing
Synchronization of manufacturing
Driven by demand rather than forecast
Continuous flow of work and people
Logical rhythm through the supply chain
Moving forward via downstream signals
Elimination of waste
Non-value adding steps removed
Value adding steps broken down and linked
Problems solved at root cause (eliminate “rocks in water”)

Change was not Instant….
SHORT
CYCLES PEOPLE
TECHNOLOGY TOTAL EMPLOYEE
STRUCTURED FLOW
INVOLVEMENT
MANUFACTURING CONTROL THROUGH
SMALL LOT
VISIBILITY
PRODUCTION HOUSEKEEPING
SETUP REDUCTION TOTAL QUALITY FOCUS
FITNESS FOR USE
LEAN
MANUFACTURING
TOTAL CONTINUOUS
QUALITY SYSTEMS IMPROVEMENT
FOCUS LEVEL LOAD & BALANCED FLOW

PREVENTIVE MAINTENANCE
SUPPLIER PARTNERSHIPS
FULL SYSTEMS
Objectives
 To improve through-put time & Yield
 To Improve Value added time & Productivity.
 To implement Autonomous Maintenance & TPM
 Team Formation
 Training
 Brain Storming and Idea Generation
 Implementation Strategies
 Monitoring and Review

CASE STUDY
Pfizer Pharmaceuticals Ltd.

Transportation
Inventory
Overproduction
Processing
Intellect
Motion
Rework
MUDA
Waiting
MUDA : Elements of Production that Add Time,

Effort, Cost, but no value
Cellular Flow Concepts
 End to end operations.
 Continuous material movement, no in process storage.
 visibility of all operations, preferably on same floor.
 Each process should be pull system instead of conventional produce and
push system.
 In short only when one batch is completely produced next batch can be
taken.
 No in process quarantine.
 Inspection and QC are non Value added activities (so time taken for
inspection and quality control activities to be minimized).
 Any process is in trouble, rest of the resources pours in to solve it
immediately.
Eye opening results Parameter Old
Facility New Cellular Flow Facility
Manufacturing Volume 10-20 Million

100 Million
Value added time
(% Total Time) 15% 40%
Cycle Time
(Dispensing to Packing) 600 Hrs 80 Hrs
Distance Traveled by Batch

(Dispensing to Packing) 220 m 73 m
Distance traveled by QC Sample 600-

800 m 0 m
Yield 97.5% 99.6 %
Addressed MUDAs and Ripped gains
MUDA GAIN
Time
Reduction in non value added Time
Batch & QC Sample movement

reduced
Motion
Max One Batch Inventory at each

Inventory stage.
Reduction in waiting due to cellular

Waiting Flow
Reduction in Yield loss.

Loss
Learning
•Quarantines cover up problems and
inefficiencies
•Operational efficiency quality
•Material is KING and should move constantly
•Simple solutions are more effective than
complex automations.
•Compact layouts result in lower operating costs
and better control
OVERVIEW
Established in 1849 by Charles Pfizer and
Charles Erhardt in Brooklyn, USA.
Business headquarters in New York.
40 million people treated with a Pfizer
medicine per day.
revenues in excess of $50 billion per annum.
employee headcount currently stands in
excess of 105,000.
TQM …..
Effectiveness obtained by :
 Effective use of resources, motivated employees.

 Healthy relationships with its suppliers.
 Stringent quality checks where scientists take drug lots and
inspect them for conformity to provisions.
 Equal importance to processes and people.
TQM…….
PROCUREMENT QUALITY CONTROL
 Strategic Sourcing
 Business process and technology

Ariba Buyer and eForm tool
 Collaborations across Pfizer division
 Supplier diversity
TQM….
SUPPLIER QUALITY MANGEMENT
 Monitoring quality of the component at source
 Audits of suppliers
 Measuring supplier performance

TQM……
DATA QUALITY MANAGEMENT

‘Pharma Navigator’-based on mySAP.com.
All manufacturing, research and development processes
like logistics management, production and quality control
are tracked with the help of
MySAP.com
Helps analyze and manage the quality of its products
Helps in fast processing of faulty batches and residual
stocks
Some of the technologies, certifications and quality
system adopted:
 ISO 9000 series
 Process Analytical Technology (PAT)
 Applications of ISO 13485
 Risk assessment and Hazard Analysis Critical Control
 Point systems
 ISO 14000 for environmental control
 ISO 14971 for quality system
 Pharmaceutical current Good Manufacturing Practices (cGMP)for
21st centaury
 Use of design for Six Sigma in reducing risk and improving quality
 OSHAS for Occupational Health and Safety award
TQM….
SCIENCE-BASED REGULATION OF
PRODUCT QUALITY
 Process analytical technology (PAT)
 JIT Adoption
 Kaizen approach

Total Quality Management in Pharma Sector

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TOTAL QUALITY

GAURAV THAKUR (92)

PREPARED FOR :Prof . RAJWADE SIR

It is a highly competitive non-assembled global industry.

Its was formed during the late nineteenth century

First this company started out as a Rhine –Based family

In 2006, the pharmaceutical industry was ranked the no. 1

In the 2009 survey, , the pharmaceutical industry was

US = Largest markets (40 % of worldwide sales)

8 out of 25 most profitable U.S. companies are

The industry is ranked fourth in the world in

The pharmaceutical industry in India meets

250 large units and about 8000 Small Scale

SAP system based on the 'Best Practice Pharmaceutical

key business processes are mapped

product runs through various stages of the quality control process

Verification of the active agent content.

Materials Management  Quality Management 

Manufacturing Volume 10-20 Million

Distance Traveled by Batch

Distance traveled by QC Sample 600-

Batch & QC Sample movement

Max One Batch Inventory at each

Reduction in waiting due to cellular

Reduction in Yield loss.

 Regulatory requirements, Compliance and Quality were TABOO

 Indian Pharma Industry entering the Global

 Contract Manufacturing becomes a big opportunity

 Operational Efficiency Critical for surviving

Driven by demand rather than forecast

Continuous flow of work and people

Logical rhythm through the supply chain

Moving forward via downstream signals

Non-value adding steps removed

Value adding steps broken down and linked

Problems solved at root cause (eliminate “rocks in water”)

FOCUS LEVEL LOAD & BALANCED FLOW

 To Improve Value added time & Productivity.

 To implement Autonomous Maintenance & TPM

 Brain Storming and Idea Generation

 Monitoring and Review

Pfizer Pharmaceuticals Ltd.

MUDA : Elements of Production that Add Time,

Manufacturing Volume 10-20 Million

Distance Traveled by Batch

Distance traveled by QC Sample 600-

Batch & QC Sample movement

Max One Batch Inventory at each

Reduction in waiting due to cellular

Reduction in Yield loss.

 Effective use of resources, motivated employees.

PROCUREMENT QUALITY CONTROL

 Business process and technology

 Collaborations across Pfizer division

 Monitoring quality of the component at source

 Measuring supplier performance

DATA QUALITY MANAGEMENT

 Process analytical technology (PAT)

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