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

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

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 .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.

250 large units and about 8000 Small Scale Units.000 registered units. . (including 5 Central Public Sector Units).The Indian Pharmaceutical sector is highly fragmented with more than 20.

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 runs through various stages of the quality control process (laboratory analysis production stage final checks stage) Verification product of the active agent content. .

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

MUDA : Elements of Production that Add Time. Effort. Cost. but no value Transportation y Inventory y Overproduction y Processing y Intellect y Motion y Rework y Waiting y MUDA .

Cellular Flow Concepts y y y y y y y y End to end operations. Inspection and QC are non Value added activities (so time taken for inspection and quality control activities to be minimized). In short only when one batch is completely produced next batch can be taken. Any process is in trouble. visibility of all operations. preferably on same floor. no in process storage. . rest of the resources pours in to solve it immediately. No in process quarantine. Continuous material movement. Each process should be pull system instead of conventional produce and push system.

5% 99.6 % .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 600800 m 0 m Yield 97.

Reduction in waiting due to cellular Flow Reduction in Yield loss. Waiting Loss .Addressed MUDAs and Ripped gains MUDA Time GAIN Reduction in non value added Time Motion Batch & QC Sample movement reduced Inventory Max One Batch Inventory at each stage.

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 Waterµ 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 waterµ) .

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

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. .

but no value . Cost. Effort.Transportation y Inventory y Overproduction y Processing y Intellect y Motion y Rework y Waiting y MUDA MUDA : Elements of Production that Add Time.

Inspection and QC are non Value added activities (so time taken for inspection and quality control activities to be minimized). Continuous material movement. no in process storage. Any process is in trouble. . visibility of all operations. No in process quarantine. Each process should be pull system instead of conventional produce and push system. preferably on same floor. In short only when one batch is completely produced next batch can be taken.Cellular Flow Concepts y y y y y y y y End to end operations. 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 600800 m 0 m Yield 97.5% 99.6 % .

Addressed MUDAs and Ripped gains MUDA Time GAIN Reduction in non value added Time Motion Batch & QC Sample movement reduced Inventory Max One Batch Inventory at each stage. Reduction in waiting due to cellular Flow Reduction in Yield loss. Waiting Loss .

‡Compact layouts result in lower operating costs and better control .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.

y . y employee headcount currently stands in excess of 105.OVERVIEW Established in 1849 by Charles Pfizer and Charles Erhardt in Brooklyn.000. y revenues in excess of $50 billion per annum. y Business headquarters in New York. y 40 million people treated with a Pfizer medicine per day. USA.

y Stringent quality checks where scientists take drug lots and inspect them for conformity to provisions. motivated employees.TQM «. y . y Healthy relationships with its suppliers.. Effectiveness obtained by : Effective use of resources. y Equal importance to processes and people.

TQM««. PROCUREMENT QUALITY CONTROL y y Strategic Sourcing Business process and technology Ariba Buyer and eForm tool Collaborations across Pfizer division Supplier diversity y y .

TQM«. SUPPLIER QUALITY MANGEMENT y Monitoring quality of the component at source Audits of suppliers Measuring supplier performance y y .

production and quality control are tracked with the help of MySAP. research and development processes like logistics management.com.com Helps analyze and manage the quality of its products Helps in fast processing of faulty batches and residual stocks .TQM«« DATA QUALITY MANAGEMENT y y y y ¶Pharma Navigator·-based on mySAP. All manufacturing.

Some of the technologies. certifications and quality system adopted: y y y y y y y y y y 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 .

SCIENCE-BASED REGULATION OF PRODUCT QUALITY y Process analytical technology (PAT) JIT Adoption Kaizen approach y y .TQM«.

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