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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