TOTAL QUALITY TOTAL QUALITY MANAGEMENT MANAGEMENT

ININ

PHARMA SECTOR 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 Few Facts of Indian Pharma IndustryPharma 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 COMPANIESTOP TEN COMPANIESRanbaxyDr. Reddy’s LaboratoriesCiplaSun PharmaLupin Laboratories Aurobindo PharmaGlaxo Smith Kline CadilaAventis PharmaIPCA

Managing batches at the press of Managing batches at the press of a buttona 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 Tracking viavia a batch tree a batch tree

Maintaining Transparency

In-house logisticsProduction 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 MUDA : Elements of Production that Add Time, Effort, Cost, but no valueAdd Time, Effort, Cost, but no value

TransportationInventoryOverproductionProcessingIntellectMotionReworkWaiting

MUDAMUDA

Cellular Flow ConceptsCellular 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 Million100 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 mYield 97.5% 99.6 %

Addressed MUDAs and Ripped gainsAddressed MUDAs and Ripped gains

MUDA GAIN

TimeReduction in non value added Time

Motion

Batch & QC Sample movement reduced

InventoryMax One Batch Inventory at each stage.

Waiting Reduction in waiting due to cellular Flow

Loss Reduction in Yield loss.

LearningLearning

•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

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

Pharmaceutical Pharmaceutical Manufacturing Manufacturing (Long Before)(Long Before)

““Rocks in the Water”Rocks in the Water”High Throughput Time High Throughput Time

(TPT)(TPT)

Indian Pharma Industry entering the Indian Pharma Industry entering the Global Generics Market Global Generics Market

Contract Manufacturing becomes a big Contract Manufacturing becomes a big opportunityopportunity

Operational Efficiency Critical for Operational Efficiency Critical for surviving Globallysurviving Globally

Pharmaceutical Pharmaceutical Manufacturing Changed Manufacturing Changed

ScenarioScenario

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”)

LEAN Manufacturing

Change was not Change was not Instant….Instant….

TECHNOLOGYSTRUCTURED FLOW MANUFACTURINGSMALL LOT PRODUCTIONSETUP REDUCTIONFITNESS FOR USE

PEOPLE TOTAL EMPLOYEE INVOLVEMENTCONTROL THROUGH VISIBILITYHOUSEKEEPINGTOTAL QUALITY FOCUS

SYSTEMSLEVEL LOAD & BALANCED FLOWPREVENTIVE MAINTENANCESUPPLIER PARTNERSHIPSFULL SYSTEMS

CONTINUOUSIMPROVEMENT

TOTAL QUALITY FOCUS

SHORT CYCLES

LEAN MANUFACTURING

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

ObjectivesObjectives

CASE STUDYCASE STUDY

Pfizer Pharmaceuticals Ltd.

MUDA : Elements of Production that Add MUDA : Elements of Production that Add Time, Effort, Cost, but no valueTime, Effort, Cost, but no value

TransportationInventoryOverproductionProcessingIntellectMotionReworkWaiting

MUDAMUDA

Cellular Flow ConceptsCellular 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 Million100 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 mYield 97.5% 99.6 %

Addressed MUDAs and Ripped gainsAddressed MUDAs and Ripped gains

MUDA GAIN

TimeReduction in non value added Time

Motion

Batch & QC Sample movement reduced

InventoryMax One Batch Inventory at each stage.

Waiting Reduction in waiting due to cellular Flow

Loss Reduction in Yield loss.

LearningLearning

•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

OVERVIEWOVERVIEW

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 …..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…….TQM…….

PROCUREMENT QUALITY CONTROL

Strategic Sourcing Business process and technology

Ariba Buyer and eForm tool

Collaborations across Pfizer division

Supplier diversity

TQM….TQM….

SUPPLIER QUALITY MANGEMENT

Monitoring quality of the component at source

Audits of suppliers

Measuring supplier performance

TQM……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 seriesProcess Analytical Technology (PAT)Applications of ISO 13485Risk assessment and Hazard Analysis Critical ControlPoint systems ISO 14000 for environmental control ISO 14971 for quality system Pharmaceutical current Good Manufacturing Practices

(cGMP)for 21st centauryUse of design for Six Sigma in reducing risk and

improving qualityOSHAS for Occupational Health and Safety award

TQM….TQM….

SCIENCE-BASED REGULATION OF PRODUCT QUALITY

Process analytical technology (PAT)

JIT Adoption

Kaizen approach