The document discusses the scope and implementation of lean aspects in the pharmaceutical industry. It begins with an introduction to lean strategies and their historical use in eliminating waste and improving efficiency. While lean has been successfully adopted in other industries, the pharmaceutical industry has been slow to implement it. The study aims to identify lean management principles that can be applied in the pharmaceutical manufacturing environment to improve quality and productivity while reducing costs. It also discusses conducting surveys of pharmaceutical companies to understand their current quality systems and openness to lean implementation. The goal is to determine how lean principles can enhance processes to achieve very high productivity, short lead times, and exceptional product quality.
The document discusses the components of DMAIC, the methodology used in Six Sigma improvement projects. It begins by outlining some key requirements for Six Sigma projects, including leadership commitment, using facts to make decisions, and cross-functional team training. It then describes each stage of DMAIC - Define, Measure, Analyze, Improve, and Control - and lists some potential tools and activities used in each stage. The document concludes by listing several statistical tools that can be used throughout the Six Sigma improvement process.
Quality management involves three key processes: quality planning, quality assurance, and quality control. Quality planning identifies quality standards and how to meet them. Quality assurance applies quality activities to ensure all processes needed to meet requirements are employed. Quality control monitors results to determine if they comply with standards and identifies ways to eliminate unsatisfying results. These three processes work together to define quality policies and ensure a project satisfies its objectives.
21 CFR Part 11 outlines FDA regulations for electronic records and electronic signatures. It requires that electronic records be trustworthy, reliable, and equivalent to paper records. It also requires that electronic signatures be equivalent to handwritten signatures. The document then outlines the key subparts and sections of 21 CFR Part 11, including requirements for controls on closed and open systems, electronic signature components and controls, and validation of electronic records and signatures.
Lean Six Sigma is a methodology that combines Lean and Six Sigma to improve processes and eliminate waste. It uses tools like DMAIC (Define, Measure, Analyze, Improve, Control) and 5S (Sort, Straighten, Shine, Standardize, Sustain) to systematically identify and remove causes of defects and minimize variability in processes. A case study on implementing Lean Six Sigma in a call center showed improvements like increasing the actualization rate from 2.6% to 20% and updating procedures to better address customer issues. The future plan is to optimize billing processes and further improve call center quality and efficiency.
This is a slide deck that starts to help those in the pharmaceutical research industry begin to understand the key differences between QC and QA. The presentation also delineates the different levels of QC and the types of QA audits. The presentation also touches on the do's and don't's of conduct during a FDA audit,
G7 Diagnostics is seeking £2.7 million in funding to develop and commercialize SaphvidTM, a point-of-care diagnostic test for early detection of pregnancy complications. The management team presented their business plan which outlined SaphvidTM's market potential, competitive advantages over current diagnostic methods, marketing and financial projections showing profitability within 5 years, and an exit strategy anticipating acquisition offers from large diagnostic companies. The presentation concluded that G7 Diagnostics has a net present value of £224 million and is requesting £300,000 in personal contribution from investors.
The document provides an overview of failure mode and effects analysis (FMEA). It discusses the history and evolution of FMEA from its origins in the aerospace industry in the 1960s to the current AIAG VDA FMEA Handbook published in 2019. The document outlines the seven step approach of the new handbook, including planning, structure analysis, function analysis, optimization, risk analysis, failure analysis, and documentation of results. It also summarizes some of the major changes between the previous AIAG 4th edition and new handbook, such as replacing RPN with action priority and revising the rating tables.
The document discusses the components of DMAIC, the methodology used in Six Sigma improvement projects. It begins by outlining some key requirements for Six Sigma projects, including leadership commitment, using facts to make decisions, and cross-functional team training. It then describes each stage of DMAIC - Define, Measure, Analyze, Improve, and Control - and lists some potential tools and activities used in each stage. The document concludes by listing several statistical tools that can be used throughout the Six Sigma improvement process.
Quality management involves three key processes: quality planning, quality assurance, and quality control. Quality planning identifies quality standards and how to meet them. Quality assurance applies quality activities to ensure all processes needed to meet requirements are employed. Quality control monitors results to determine if they comply with standards and identifies ways to eliminate unsatisfying results. These three processes work together to define quality policies and ensure a project satisfies its objectives.
21 CFR Part 11 outlines FDA regulations for electronic records and electronic signatures. It requires that electronic records be trustworthy, reliable, and equivalent to paper records. It also requires that electronic signatures be equivalent to handwritten signatures. The document then outlines the key subparts and sections of 21 CFR Part 11, including requirements for controls on closed and open systems, electronic signature components and controls, and validation of electronic records and signatures.
Lean Six Sigma is a methodology that combines Lean and Six Sigma to improve processes and eliminate waste. It uses tools like DMAIC (Define, Measure, Analyze, Improve, Control) and 5S (Sort, Straighten, Shine, Standardize, Sustain) to systematically identify and remove causes of defects and minimize variability in processes. A case study on implementing Lean Six Sigma in a call center showed improvements like increasing the actualization rate from 2.6% to 20% and updating procedures to better address customer issues. The future plan is to optimize billing processes and further improve call center quality and efficiency.
This is a slide deck that starts to help those in the pharmaceutical research industry begin to understand the key differences between QC and QA. The presentation also delineates the different levels of QC and the types of QA audits. The presentation also touches on the do's and don't's of conduct during a FDA audit,
G7 Diagnostics is seeking £2.7 million in funding to develop and commercialize SaphvidTM, a point-of-care diagnostic test for early detection of pregnancy complications. The management team presented their business plan which outlined SaphvidTM's market potential, competitive advantages over current diagnostic methods, marketing and financial projections showing profitability within 5 years, and an exit strategy anticipating acquisition offers from large diagnostic companies. The presentation concluded that G7 Diagnostics has a net present value of £224 million and is requesting £300,000 in personal contribution from investors.
The document provides an overview of failure mode and effects analysis (FMEA). It discusses the history and evolution of FMEA from its origins in the aerospace industry in the 1960s to the current AIAG VDA FMEA Handbook published in 2019. The document outlines the seven step approach of the new handbook, including planning, structure analysis, function analysis, optimization, risk analysis, failure analysis, and documentation of results. It also summarizes some of the major changes between the previous AIAG 4th edition and new handbook, such as replacing RPN with action priority and revising the rating tables.
The document provides guidance on developing an effective control plan with three key sections:
1. The administrative section identifies critical information about the part or process including part numbers, suppliers, and required approval signatures.
2. The main section defines the key process parameters and controls for each step, including specifications, measurement techniques, sample sizes, frequencies, control methods, and reaction plans.
3. Effective control plans also include audit plans as a separate line to regularly validate that the documented controls match actual practice and ensure continuous improvement.
This document provides an overview of basic quality management concepts including total quality management (TQM). It discusses key aspects of TQM such as the customer and supplier focus, benefits which include lower costs and satisfied customers, and costs such as prevention and inspection costs. Historical contributors to TQM are also summarized, including Deming's emphasis on statistical process control and prevention of errors, Juran's quality trilogy approach, and Crosby's zero defects philosophy.
Quality Function Deployment (QFD) is a systematic approach to product development that focuses on customer needs. It involves translating customer demands into appropriate technical requirements through the use of a matrix called the "House of Quality." The House of Quality graphically displays the relationships between customer needs, technical characteristics of the product, and the product's competitors. This helps companies design products that meet customer needs and outperform the competition.
This document provides an overview of Six Sigma, including:
- The basic concepts of Six Sigma and how it is used to drive improvements through reducing variation.
- Key aspects like the DMAIC process and defining critical-to-quality metrics.
- Examples of companies that have implemented Six Sigma successfully, reducing costs significantly through improving quality and processes.
- The different roles involved in Six Sigma projects and challenges that may be encountered.
This document discusses quality audits and their purpose. It defines a quality audit as an independent examination to verify conformity with quality standards. Quality audits can be internal or external, and audit products, processes, or entire quality systems. The objectives of quality audits are to ensure standards are met, quality is maintained, and areas for improvement can be identified. A quality audit process typically involves planning the audit, conducting interviews and documentation reviews, reporting findings, and identifying corrective actions.
FMEA is a systematic method for evaluating potential failures in a design, manufacturing or assembly process. It involves analyzing possible failures, identifying their causes and effects, and prioritizing issues based on severity, occurrence, and detection. The process results in a risk priority number to determine which failures should be addressed first. FMEA is widely used in industries like automotive, aerospace, healthcare to prevent failures and improve quality and safety.
Computer System Validation (CSV) is a core requirement for several industries. The aim of Computer System Validation is to ensure, through documentation, that the computer systems function the way they are intended to, consistently, repeatedly and reproducibly, somewhat in the manner expected of scientific experiments. So, the validation, meaning authentication or corroboration, is something that has to be done right from the start, that is, defining the computer system, to their use and going all the way right up to the time the computer system is retired.
Computerized System Validation Business Intelligence SolutionsDigital-360
Executive Summary
Regulated pharmaceutical, biotech and medical device companies are challenged to develop manufacturing capabilities quickly and cost-effectively while at the same time safeguarding product quality and patient safety.
Validation has been an essential part of regulated industries for over 20 years, yet as the field has evolved, little has changed in the business, or manual, approach to validation.
The document discusses using Six Sigma methodology to reduce in-process rejections at a manufacturing unit producing wheel cylinders. It analyzes the main causes of rejection, implements solutions, and measures the results. The key defects causing rejection were identified as main bore shift and M10 damage. Solutions like correcting hydraulic leaks, improving clamping, and modifying casting processes reduced monthly rejections from 205 to 15 and increased the sigma rating from 2.92 to 3.62, saving approximately $42,780 annually.
[Note: This is a partial preview. To download this presentation, visit:
https://www.oeconsulting.com.sg/training-presentations]
Failure Mode & Effects Analysis (FMEA) is a step-by-step approach for identifying all possible failures in a design, a manufacturing or assembly process, or a product or service. The purpose of the FMEA is to take actions to eliminate or reduce failures, starting with the highest-priority ones. FMEA also documents current knowledge and actions about the risks of failures, for use in continuous improvement.
In this training presentation, you can teach your employees on the proper steps to construct an FMEA for a design or process, and then implement action plans to eliminate or reduce the risks of potential failures.
LEARNING OBJECTIVES
1. Understand what an FMEA is, why it is used, and when can it be deployed
2. Understand the definitions, scoring system and calculations used in an FMEA
3. Learn the steps to developing an FMEA and the pitfalls to avoid
CONTENTS
1. Introduction to FMEA
2. FMEA: Definitions, Scoring System & Calculations
3. FMEA Procedure
4. FMEA Example
1) Several case studies are presented involving FDA regulation violations and their consequences. Schering-Plough ignored repeated FDA warnings and was fined $500 million. Barr Laboratories routinely retested drug batches instead of following procedures for out-of-specification results, leading to a legal case.
2) Chiron's flu vaccine manufacturing plant in the UK had its license suspended in 2004, eliminating nearly half of the US supply that year. Baxter recalled blood thinner Heparin after patients had allergic reactions, which was later traced to a contaminated ingredient from a Chinese supplier.
3) Regulators must take supplier quality into account, as sponsors are responsible for ensuring third-party manufacturers meet standards. The FDA found numerous problems
ABOUT THE TRAINING PROGRAM :-
Failure Mode and Effects Analysis or FMEA is a structured technique to analyze a process to determine shortcomings and opportunities for improvement. By assessing the severity of a potential failure, the likelihood that the failure will occur, and the chance of detecting the failure, dozens or even hundreds of potential issues can be prioritized for improvement.
DESIGNED FOR :-
Sr. Engineer, Engineer, Supervisor and Foreman engaged in maintenance, operation, Store, Supply chain, Quality, Safety and Engineering activities.
OBJECTIVE :-
Employees completing this training will be able to effectively participate on an FMEA team and can make immediate contributions to quality and productivity improvement efforts.
GAMP 5 provides a framework for validating computerized systems used in regulated industries. It recommends a life cycle approach involving quality risk management throughout planning, development, validation and operation. Key activities for regulated companies include governance, identifying systems' impact, and ensuring compliance. Suppliers play an important role by providing documentation, testing systems, and supporting changes and maintenance. The level of validation should be based on a system's risk, complexity and novelty.
Understanding Enterprise Quality Management Systems (EQMS)Sparta Systems
The quality software landscape has progressed to become enterprise-level solutions, whose integrated systems enable organizations to implement automated quality processes tailored to align with each of their specific products and business practices. This presentation from Sparta Systems explains the concept of Enterprise Quality Management Systems (EQMS).
This document provides an overview of Failure Mode and Effects Analysis (FMEA). FMEA is a systematic method used to evaluate potential failure modes in a design, process or service and their causes and effects. It involves analyzing potential failures, their likelihood and severity, and identifying actions to address potential failures with high risk priority numbers. The document defines key terms in FMEA like severity, occurrence, detection and risk priority number. It also outlines the FMEA process, including steps to identify potential failure modes, effects, causes, current controls and priority actions.
The document provides an overview of Six Sigma, including:
1) It defines Six Sigma as a methodology for continuous improvement and creating high quality products and processes using statistical tools.
2) It discusses the origins and growth of Six Sigma at Motorola and GE in the 1980s-1990s.
3) It describes the DMAIC methodology used for process improvement projects and the roles of Master Black Belts, Black Belts, and Green Belts in a Six Sigma organization.
The document provides an overview of Total Quality Management (TQM) principles and processes for continuous improvement. It discusses Deming's 14 points for TQM and 7 deadly diseases. Steps for implementing TQM include obtaining management commitment, educating staff, focusing on customers, establishing improvement teams, and using tools like control charts. Benefits include reduced costs from fewer defects as well as improved customer satisfaction and employee engagement.
Taguchi Method is a new engineering design optimisation methodology that improves the quality of existing products and processes and simultaneously reduces their costs very rapidly, with minimum engineering resources and development man-hours
The document discusses Failure Mode and Effects Analysis (FMEA), a systematic method for evaluating potential failures in design, manufacturing, and production processes. It was originally developed in the 1940s for the military and is now commonly used in various industries. An FMEA involves analyzing how and how often a process might fail and classifying the failures by severity, occurrence, and detection. The analysis helps prioritize risks and identify actions needed to prevent failures.
I've been asked to put together a basic (and therefore relatively quick) introduction to Lean Six Sigma & DMAIC. While it’s not yet finished, I thought I would put it out there for people to comment on. Since the presentation is supposed to be training material there’s more text on the slides than I would prefer, but there are a few exercises and games to get the trainees involved.
I've put the PowerPoint version on my blog:
http://alesandrab.wordpress.com/2013/06/07/introduction-to-lean-six-sigma-dmaic/
This document discusses how pharmaceutical companies can improve clinical development and manufacturing processes through product lifecycle management (PLM). It identifies 7 key business processes for transforming R&D operations: 1) drug development program management, 2) regulatory archive management, 3) clinical trial management, 4) scale-up and commercial manufacturing, 5) quality management, 6) packaging and marketing asset management, and 7) global product registration. Implementing PLM using Oracle's solutions can deliver ROI by improving productivity, reducing time to market, and lowering development costs.
Product lifecycle management in the pharmaceutical industryGeorgi Daskalov
Pharmaceutical companies face pressure to improve product pipelines, accelerate time to market, and improve margins on existing products, while maintaining strict regulatory compliance. A comprehensive product lifecycle management (PLM) solution can help address these challenges by providing visibility and control across the entire drug development process from discovery through commercialization. PLM focuses on leveraging research and development efforts to efficiently develop new drugs and move them through the various phases of the drug lifecycle from the different internal and external functions involved. This allows for improved collaboration and management of changes to optimize profitability throughout the drug's economic life.
The document provides guidance on developing an effective control plan with three key sections:
1. The administrative section identifies critical information about the part or process including part numbers, suppliers, and required approval signatures.
2. The main section defines the key process parameters and controls for each step, including specifications, measurement techniques, sample sizes, frequencies, control methods, and reaction plans.
3. Effective control plans also include audit plans as a separate line to regularly validate that the documented controls match actual practice and ensure continuous improvement.
This document provides an overview of basic quality management concepts including total quality management (TQM). It discusses key aspects of TQM such as the customer and supplier focus, benefits which include lower costs and satisfied customers, and costs such as prevention and inspection costs. Historical contributors to TQM are also summarized, including Deming's emphasis on statistical process control and prevention of errors, Juran's quality trilogy approach, and Crosby's zero defects philosophy.
Quality Function Deployment (QFD) is a systematic approach to product development that focuses on customer needs. It involves translating customer demands into appropriate technical requirements through the use of a matrix called the "House of Quality." The House of Quality graphically displays the relationships between customer needs, technical characteristics of the product, and the product's competitors. This helps companies design products that meet customer needs and outperform the competition.
This document provides an overview of Six Sigma, including:
- The basic concepts of Six Sigma and how it is used to drive improvements through reducing variation.
- Key aspects like the DMAIC process and defining critical-to-quality metrics.
- Examples of companies that have implemented Six Sigma successfully, reducing costs significantly through improving quality and processes.
- The different roles involved in Six Sigma projects and challenges that may be encountered.
This document discusses quality audits and their purpose. It defines a quality audit as an independent examination to verify conformity with quality standards. Quality audits can be internal or external, and audit products, processes, or entire quality systems. The objectives of quality audits are to ensure standards are met, quality is maintained, and areas for improvement can be identified. A quality audit process typically involves planning the audit, conducting interviews and documentation reviews, reporting findings, and identifying corrective actions.
FMEA is a systematic method for evaluating potential failures in a design, manufacturing or assembly process. It involves analyzing possible failures, identifying their causes and effects, and prioritizing issues based on severity, occurrence, and detection. The process results in a risk priority number to determine which failures should be addressed first. FMEA is widely used in industries like automotive, aerospace, healthcare to prevent failures and improve quality and safety.
Computer System Validation (CSV) is a core requirement for several industries. The aim of Computer System Validation is to ensure, through documentation, that the computer systems function the way they are intended to, consistently, repeatedly and reproducibly, somewhat in the manner expected of scientific experiments. So, the validation, meaning authentication or corroboration, is something that has to be done right from the start, that is, defining the computer system, to their use and going all the way right up to the time the computer system is retired.
Computerized System Validation Business Intelligence SolutionsDigital-360
Executive Summary
Regulated pharmaceutical, biotech and medical device companies are challenged to develop manufacturing capabilities quickly and cost-effectively while at the same time safeguarding product quality and patient safety.
Validation has been an essential part of regulated industries for over 20 years, yet as the field has evolved, little has changed in the business, or manual, approach to validation.
The document discusses using Six Sigma methodology to reduce in-process rejections at a manufacturing unit producing wheel cylinders. It analyzes the main causes of rejection, implements solutions, and measures the results. The key defects causing rejection were identified as main bore shift and M10 damage. Solutions like correcting hydraulic leaks, improving clamping, and modifying casting processes reduced monthly rejections from 205 to 15 and increased the sigma rating from 2.92 to 3.62, saving approximately $42,780 annually.
[Note: This is a partial preview. To download this presentation, visit:
https://www.oeconsulting.com.sg/training-presentations]
Failure Mode & Effects Analysis (FMEA) is a step-by-step approach for identifying all possible failures in a design, a manufacturing or assembly process, or a product or service. The purpose of the FMEA is to take actions to eliminate or reduce failures, starting with the highest-priority ones. FMEA also documents current knowledge and actions about the risks of failures, for use in continuous improvement.
In this training presentation, you can teach your employees on the proper steps to construct an FMEA for a design or process, and then implement action plans to eliminate or reduce the risks of potential failures.
LEARNING OBJECTIVES
1. Understand what an FMEA is, why it is used, and when can it be deployed
2. Understand the definitions, scoring system and calculations used in an FMEA
3. Learn the steps to developing an FMEA and the pitfalls to avoid
CONTENTS
1. Introduction to FMEA
2. FMEA: Definitions, Scoring System & Calculations
3. FMEA Procedure
4. FMEA Example
1) Several case studies are presented involving FDA regulation violations and their consequences. Schering-Plough ignored repeated FDA warnings and was fined $500 million. Barr Laboratories routinely retested drug batches instead of following procedures for out-of-specification results, leading to a legal case.
2) Chiron's flu vaccine manufacturing plant in the UK had its license suspended in 2004, eliminating nearly half of the US supply that year. Baxter recalled blood thinner Heparin after patients had allergic reactions, which was later traced to a contaminated ingredient from a Chinese supplier.
3) Regulators must take supplier quality into account, as sponsors are responsible for ensuring third-party manufacturers meet standards. The FDA found numerous problems
ABOUT THE TRAINING PROGRAM :-
Failure Mode and Effects Analysis or FMEA is a structured technique to analyze a process to determine shortcomings and opportunities for improvement. By assessing the severity of a potential failure, the likelihood that the failure will occur, and the chance of detecting the failure, dozens or even hundreds of potential issues can be prioritized for improvement.
DESIGNED FOR :-
Sr. Engineer, Engineer, Supervisor and Foreman engaged in maintenance, operation, Store, Supply chain, Quality, Safety and Engineering activities.
OBJECTIVE :-
Employees completing this training will be able to effectively participate on an FMEA team and can make immediate contributions to quality and productivity improvement efforts.
GAMP 5 provides a framework for validating computerized systems used in regulated industries. It recommends a life cycle approach involving quality risk management throughout planning, development, validation and operation. Key activities for regulated companies include governance, identifying systems' impact, and ensuring compliance. Suppliers play an important role by providing documentation, testing systems, and supporting changes and maintenance. The level of validation should be based on a system's risk, complexity and novelty.
Understanding Enterprise Quality Management Systems (EQMS)Sparta Systems
The quality software landscape has progressed to become enterprise-level solutions, whose integrated systems enable organizations to implement automated quality processes tailored to align with each of their specific products and business practices. This presentation from Sparta Systems explains the concept of Enterprise Quality Management Systems (EQMS).
This document provides an overview of Failure Mode and Effects Analysis (FMEA). FMEA is a systematic method used to evaluate potential failure modes in a design, process or service and their causes and effects. It involves analyzing potential failures, their likelihood and severity, and identifying actions to address potential failures with high risk priority numbers. The document defines key terms in FMEA like severity, occurrence, detection and risk priority number. It also outlines the FMEA process, including steps to identify potential failure modes, effects, causes, current controls and priority actions.
The document provides an overview of Six Sigma, including:
1) It defines Six Sigma as a methodology for continuous improvement and creating high quality products and processes using statistical tools.
2) It discusses the origins and growth of Six Sigma at Motorola and GE in the 1980s-1990s.
3) It describes the DMAIC methodology used for process improvement projects and the roles of Master Black Belts, Black Belts, and Green Belts in a Six Sigma organization.
The document provides an overview of Total Quality Management (TQM) principles and processes for continuous improvement. It discusses Deming's 14 points for TQM and 7 deadly diseases. Steps for implementing TQM include obtaining management commitment, educating staff, focusing on customers, establishing improvement teams, and using tools like control charts. Benefits include reduced costs from fewer defects as well as improved customer satisfaction and employee engagement.
Taguchi Method is a new engineering design optimisation methodology that improves the quality of existing products and processes and simultaneously reduces their costs very rapidly, with minimum engineering resources and development man-hours
The document discusses Failure Mode and Effects Analysis (FMEA), a systematic method for evaluating potential failures in design, manufacturing, and production processes. It was originally developed in the 1940s for the military and is now commonly used in various industries. An FMEA involves analyzing how and how often a process might fail and classifying the failures by severity, occurrence, and detection. The analysis helps prioritize risks and identify actions needed to prevent failures.
I've been asked to put together a basic (and therefore relatively quick) introduction to Lean Six Sigma & DMAIC. While it’s not yet finished, I thought I would put it out there for people to comment on. Since the presentation is supposed to be training material there’s more text on the slides than I would prefer, but there are a few exercises and games to get the trainees involved.
I've put the PowerPoint version on my blog:
http://alesandrab.wordpress.com/2013/06/07/introduction-to-lean-six-sigma-dmaic/
This document discusses how pharmaceutical companies can improve clinical development and manufacturing processes through product lifecycle management (PLM). It identifies 7 key business processes for transforming R&D operations: 1) drug development program management, 2) regulatory archive management, 3) clinical trial management, 4) scale-up and commercial manufacturing, 5) quality management, 6) packaging and marketing asset management, and 7) global product registration. Implementing PLM using Oracle's solutions can deliver ROI by improving productivity, reducing time to market, and lowering development costs.
Product lifecycle management in the pharmaceutical industryGeorgi Daskalov
Pharmaceutical companies face pressure to improve product pipelines, accelerate time to market, and improve margins on existing products, while maintaining strict regulatory compliance. A comprehensive product lifecycle management (PLM) solution can help address these challenges by providing visibility and control across the entire drug development process from discovery through commercialization. PLM focuses on leveraging research and development efforts to efficiently develop new drugs and move them through the various phases of the drug lifecycle from the different internal and external functions involved. This allows for improved collaboration and management of changes to optimize profitability throughout the drug's economic life.
This document summarizes a study that aimed to identify and prioritize the key total quality management (TQM) indicators in the Iranian pharmaceutical industry using the fuzzy analytical network process (ANP). The researchers identified 7 key TQM factors (employees, top managers, customers, distributors, suppliers, education, and teamwork) based on expert input and literature. They then developed pairwise comparison matrices to prioritize these factors based on 3 key performance indicators (customer satisfaction, employee satisfaction, societal impact). The results showed that top managers and employees had the highest priority to achieve an appropriate quality level in the pharmaceutical industry.
The opportunities for the Indian pharmaceutical industry are immense but increasing competition, increasing regulatory pressures and stringent price control means that companies need to constantly improve their costs and service levels. Supply chain efficiencies will play a crucial role going forward and will become the key differentiator for companies. Companies will therefore need to adopt an approach that encompasses strategic, tactical and operational interventions to remain competitive and create value for their customers
The document discusses trends in GMP (good manufacturing practices) compliance in the pharmaceutical industry from 2012. The top six trends are: 1) Increasing number of inspections, 2) Increasing number of warning letters, 3) Increasing enforcement penalties, 4) Increasing harmonization between regulatory agencies, 5) Increasing use of science and technology, and 6) Increasing use of subject matter experts. The document emphasizes that knowledge of these compliance trends can help companies improve processes, avoid citations, and strengthen standard operating procedures.
Enterprise Labeling for the Pharmaceutical IndustryLoftware
For the pharmaceutical industry, the focus is on patient safety and improved patient outcomes. It’s also on driving greater efficiencies, cost reductions, and collaboration with contract manufacturers throughout the supply chain. In this environment, labeling is growing in importance, and there are a number of reasons why.
The document discusses the Master of Science in Management of Projects and Programs degree from Brandeis University. It summarizes that the MSMPP curriculum aims to advance project and program management professionals through a balanced curriculum covering both technical and soft skills. The curriculum is aligned with but not limited to PMI standards, allowing it to have an applied focus while recognizing industry standards. The degree and its curriculum are highly relevant for project managers working in the pharmaceutical industry due to courses covering topics like risk management, scheduling, and leadership that address that industry's key challenges of quality and timelines.
1
Lean Supply Chain Management
2
Table of contents
1. Introduction ............................................................................................................ 3
1.1 What is lean ……………………………………………………………………… 4
2. Why leans supply chain is needed?........................................................................ 5
3. Benefits of lean supply chain management .......................................................... 6
4. Implementation of Lean SCM: ................................................................................... 6
5. Challenges faced while implementing lean SCM: .................................................... 8
6 .Best practices that support Lean SCM process:.......................................................... 9
7. Concluding remarks................................................................................................ 11
8. References. .................................................................................................... 12
3
Lean supply chain management
1-Introduction
Supply chain is an established network of processes that starts from procurement of raw material;
conversion of raw material into final product and then distribution of that finished product to
customers. Over last two decades, the concept of lean supply chain management has gained great
importance from both academics and practitioners. To gain competitive advantages and to
survive in this dynamic environment firm are in need of delivering quality product with
minimum wastage of resources. Therefore the concept of lean Supply chain management is more
practical now a day’s then before it. Lean production is an integrated activity in SCM that is
aimed at achieving high volume production with minimum wastage of raw materials. It focuses
on improving the efficiency of processes on continuous basis, minimizing wastage and
eliminating almost all activities that does add any value in overall supply chain. Lean production
is considered a innovative way of thinking and thus it includes the integration of firms vision,
culture and strategy in such a way that it can serve the customer by providing high quality
product with in low cost and on short delivery Alabama Technology Network, 1998; Inman,
1999; Davis and Heineke,( 2005) cited by Agus& Hajinoor(2012).
Lean production is such a socio-technical system that is aimed on removing wastage by
minimizing supplier, customers and internal variability among firms operations. Lean production
is not only element that helps in achieving goals of Lean Supply Chain, it also includes product
development phase and aspects of distribution channel. Firms that want to implement LSCM
must also manage variable supply of product, processing time, demand ...
Shamisha Learning Center, Ahmedabad, Gujarat, India-Specialized Training, Workshops and courses on Quality, Regulatory, R & D, Supply Chain and Manufacturing
Process improvement techniques and its applicability in pharma mfg an overviewVikalpNagori1
The document discusses various process improvement techniques and their applicability in pharmaceutical manufacturing. It describes techniques like Six Sigma, Lean Manufacturing, Lean Six Sigma, Total Quality Management, Toyota Production System/Just-in-Time, Theory of Constraints, and tools like FMEA and PDCA cycle. These techniques aim to reduce defects, waste, variation and improve efficiency in pharmaceutical operations throughout the product lifecycle from development to manufacturing to distribution. The document emphasizes applying these techniques and tools at various stages like development, manufacturing, and lifecycle management to ensure defect-free quality and efficient processes.
Oppi Ey Report Unlocking The Potential Of The Pharma Distribution Channelhealthcaremanas
The document discusses unlocking the potential of the pharmaceutical distribution channel in India. A survey was conducted of pharmaceutical companies, distributors, and retailers. Key findings include: sales are being lost due to ineffectiveness of the post-CFA supply chain in making products available to consumers; and excess inventory levels and month-end inventory skews exist due to inefficiencies in the supply chain. The implications for the industry are that distribution needs to be strategically leveraged for growth rather than seen as an operational function alone. Potential solutions and their benefits are outlined.
This document discusses the importance and management of mature pharmaceutical products. Some key points:
- Mature products past marketing exclusivity are still important sources of revenue and require ongoing management to ensure safety and compliance with regulations.
- An integrated approach is needed to efficiently oversee regulatory activities, risk management, labeling, and pharmacovigilance for mature product portfolios.
- Outsourcing these functions to a service provider allows companies to focus internal resources on new products while ensuring all regulatory commitments for mature products are met. This integrated model can streamline processes and management of mature product lifecycles.
Based on reading Ch 1 and 2 from the above book, Reflection-in-Ac.docxcherishwinsland
This document discusses a study on how operational excellence has facilitated McDonald's success in the fast food industry. Key findings from interviews with McDonald's top management include:
1. McDonald's implements strategies for continuous improvement like improving menus, products, customer service and delivery.
2. Other operational excellence strategies used include employee development, customer satisfaction, continuous learning, innovation, and efficient delivery systems.
3. McDonald's demonstrates aspects of operational excellence like results-focus, improvement, empowerment, customer value, and technological innovation.
4. McDonald's has recruited expertise to a large extent to help leverage operational excellence as part of its strategy.
This document provides an overview of regulatory affairs for drugs. It defines key terms like regulatory affairs, dossier, CTD, eCTD, DMF, NDA, ANDA, and INDA. It describes the role of regulatory affairs experts in guiding product development according to regulatory requirements, compiling dossiers for submission, and ensuring post-marketing compliance. The document outlines a 10 step process for regulatory product development and regulatory submission preparation. It also discusses quality management systems for regulatory compliance and the role of regulatory affairs in marketing and advertising compliance.
Study of the Methods for Decision Making in the Monitoring and Control of Pro...IRJET Journal
This document discusses methods for decision making in monitoring and controlling production processes in Ecuadorian pharmaceutical industries. It conducted a survey of 16 pharmaceutical companies producing injectables and tablets. The survey aimed to understand the current situation regarding monitoring and control applied in production processes. It found that companies make decisions based on experience or spreadsheets, with few using computer tools. It proposed using a balanced scorecard and business architecture approach to organize information and processes to improve decision making, reduce risks, and increase productivity and profitability. The project aims to help pharmaceutical industries in Ecuador improve production monitoring and control for quality medicines.
While development of promising new products is an obvious area of focus for big pharma, there is also great pressure to grow or sustain revenue from established/mature products whilst keeping maintenance costs low. This whitepaper discusses how regulatory compliance and reducing product risk can be achieved whilst still working within these cost constraints. It also lays out why marketing authorization holders (MAH) should analyze their existing operating models for maintaining mature products and how they can benefit from an integrated safety, regulatory and benefit-risk model.
The document provides a market analysis for an analytics company called AlphaMD to enter the pharmaceutical market in the UAE. It includes a literature review on the pharmaceutical sector in UAE, identifying key parameters and needs of target companies through interviews. Based on a decision matrix, marketing pharmaceutical companies were identified as the top target. Recommendations include providing competitive intelligence and contracting services at affordable prices while maintaining quality. Limitations include lack of financial data from SMEs and limited interviews.
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forumpost_12686_1397754_109973_2258107.txt
ORIGINALITY REPORT
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Submitted to Campbellsville University
St udent Paper
link.springer.com
Int ernet Source
forumpost_12686_1397754_109973_2258107.txt
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S/V T his subject and verb may no t agree. Pro o f read the sentence to make sure the subject agrees
with the verb.
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forumpost_12686_1397754_109973_2258107.txtby Ravinder Kommerelliforumpost_12686_1397754_109973_2258107.txtORIGINALITY REPORTPRIMARY SOURCESforumpost_12686_1397754_109973_2258107.txt
Running head: OPERATIONS EXCELLENCE
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OPERATIONS EXCELLENCE
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Practicum – Week 6 Journal Entry
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The impact of Operation Excellence on the Performance of McDonald’s in the Fast Food Industry
1.0 Introduction
Businesses operate in the competitive environment and thus operational excellence facilitates the execution of a business strategy in a reliable and consistent manner. The operational excellence strategy derives the competitiveness of the business from enforcing practices that aim at achieving better results. A company enforces the most effective strategy that has minimal operational risks, low operation costs, and enhanced revenue relative to its rivals (Oakman, 2014). Mainly, operations excellence is a management philosophy embedded on continuous improvement modes, such as lean thinking, Scientific Management, and Six Sigma. Importantly, the focus of operational excellence is on long-term improvement and change in organizational culture in order to realize sustainability. The fast food industry, like any other market, is very competitive. In effect, players in the industry strive to enforce operation excellence as a way of gaining leverage and remaining ahead of competitors. One of the firms operating within this industry is McDonald's. McDonald's was established on 15 April 1955, Des Plaines, Illinois, and since then, the company has continued to dominate the industry and its global presence is a good indication of how the company has remained successful amidst the competition. In effect, the objective of the research is to review the manner in which operational excellence has facilitated McDonalds’s success within the global fast food industry.
1.1 Background
As postulated by Oakman (2014), organizations that pursue operational excellence strive to manage their business and operations using a systemic approach as well as investing in developing the right organ.
INTRODUCTIONThe increasing discussion about rising healthcare co.docxvrickens
INTRODUCTION
The increasing discussion about rising healthcare cost is fuelled by reports that General Motors paid more for healthcare than for steel per vehicle in 2004,1 and Starbucks paid more for health insurance than for coffee in 2005.2 The continuing rise in development costs for drugs has increased pressure on R&D organisations to contribute to higher efficiency in the overall process of coming up with new drugs.
In the last few years the industry has made significant efforts to address these challenges3 and to increase the productivity of the drug development process. Some of the initiatives have without doubt led to considerable improvements. Examples are the earlier determination of a drug's toxicology profile and early tests to investigate the suitability of a new drug candidate for oral administration or once a day dosing. The question is no longer how good we are in what we are doing but whether we are doing the right things. Further improvements of the overall process should shift from attempts of enhancing effectiveness to a greater emphasis on the efficiency of the processes applied.
In this context a lot of emphasis is put on portfolio management. In the broadest definition, portfolio management describes the process of maximising the value of R&D portfolios through proper resource allocation. This requires an alignment of portfolio management with strategic business objectives. Such objectives should not only be general (e.g., innovation) and quantitative (eg ROI or sales targets). They should also define disease areas of interest, clearly outline the remaining medical needs, and specify the indications that are considered worth pursuing. This will enable decision makers and functional R&D managers to identify projects with both strategic fit and a high value proposition. Depending on the size of the organisation, either a corporate or therapeutic area strategies need to be developed, approved, and endorsed by the entire organisation.
Value-driven project and portfolio management implies quantitative financial and risk analysis of individual projects and overall portfolios. Such analyses elucidate options for improving the value and risk structure of individual projects on the one hand and therapeutic areas or overall corporate portfolios on the other hand. They are applicable and relevant to companies of any size. Value-driven project and portfolio management is a methodology enabling the alignment of project decisions with corporate strategy and defined business objectives.
Although portfolio management has been applied in the financial industry for many years and Harry Markowitz was honoured with the Nobel Prize for outlining this concept it was only around the end of the last century that the application of value-driven portfolio management in the pharmaceutical industry was published. 4 Around the same time, an investigation across various industries provided evidence that portfolio management based on quantitative fin ...
The document discusses quality management systems in the pharmaceutical industry. It states that quality management systems (QMS) rely on regulations and guidelines to ensure effective quality control in pharmaceutical companies. The International Council for Harmonization (ICH) guideline provides a model for an effective QMS and is intended to assist manufacturers in maintaining quality and safety of their products and services. QMS is an important aspect of the pharmaceutical industry for regulating quality and safety.
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Welcome to UiPath Test Automation using UiPath Test Suite series part 6. In this session, we will cover Test Automation with generative AI and Open AI.
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What will you get from this session?
1. Insights into integrating generative AI.
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3. Practical demonstrations
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Test Automation with generative AI and Open AI.
UiPath integration with generative AI
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CI/CD with in UiPath
End-to-end overview of CI/CD pipeline with Azure devops
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2. International Journal of Management Research and Development (IJMRD) ISSN 2248-938X
(Print), ISSN 2248-9398 (Online) Volume 4, Number 1, January-March (2014)
18
methods, manufacturing efficiency and whole supply chain performance. These organizations are
struggling to find ways to cut costs.
In any industry where success is increasingly driven by satisfaction scorecards, reliable
access to key talent is essential for meeting the demand for quality service. Over the last decade lean
implementation has become the vital driver of operational change, eliminating waste and improving
process. It is important to note that lean is heavily based on the mindset of the people and practices
that continuous improvement can be found through the power of respect for people. The culture of
the company is crucial in designing the business system that motivates people to want to improve,
teaching them the tools, methods and principles and motivates them to apply those tools every day.
Lean scope and implementation improves the manufacturing process and business strategy
and it involves the employees at all levels.
Today Industry trends shows that many pharmaceutical manufacturers are following some of
the manufacturing principles in the way for significant improvement of operational efficiency and
quality, while facilitating compliance. To ensure a solid position on the market and competitive
advantage they are looking to increase the efficiency of their operational and manufacturing process -
optimizing resources, improving efficiency and short lead times with best product quality.
Even if the change is good and beneficial, its lack of acceptance by the relevant stakeholders
can bring in the uncertainty in the consequence of the change. Nowadays, Pharma industry faces the
dilemma between pursuing the competitive advantage of cutting edge technology and the risk of
uncertainty associated with it. So, the Implementing lean is a journey, not a process
2. OBJECTIVES / IMPORTANCE OF THE STUDY
This research study involves in the “Scope and Implementation of Lean aspects in
Pharmaceutical Industry”. This research study is to find out the scope and implementation of lean
principles in the Pharma environment which in turn not identified and not applied as an effective tool
in the business processes.
The following core objectives were taken into consideration during the research study,
• Is there any scope for lean applications?
• Proper selection of the lean methods for the implementation?
• People involvement and company culture?
• View about organizational structure and quality system followed in the selected
pharmaceutical companies in Hyderabad, AndraPradesh.
• Factors influencing quality system management in medium scale pharmaceutical firms.
• Steps implemented to improve the quality / productivity to larger extent in the surveyed
pharmaceutical firms.
• How the whole system functions towards the Very high product quality with respect to cost
and productivity?
• Identify the factors which determine the complete quality system management of the selected
pharmaceutical firms. (Quality Focus)
• What are the management principles / factors already exist with the pharmaceutical industries
but the implementation aspects are very weak. (Tools / Goals)
• Whether lean management principles can be applied effectively?
• What is the business process and workflow?
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• To offer suitable suggestions for implementation of lean, improvement, conclusions in the
implementation of the lean management principles in the pharmaceutical firms to enhance the
high productivity, short lead times thus by reduce the cost.
Note: All the above factors are covered in the survey questionnaire.
2.1. UNDERSTANDING THE SCOPE OF LEAN
2.1.1 STATEMENT OF THE PROBLEM
Lean has entered management consciousness in a big way in recent years. Nowadays many
pharmaceutical companies are relying on the management concepts to improve the business
processes. However, in most cases companies took only few steps towards the identifying and
implementation of lean principles before but on later stage they are falling back into old habits. As a
result, the Pharmaceutical industries lag in efficiency behind other major manufacturing industries
such as the automotive and consumer goods sectors.
Actually 20 years ago, many manufacturers from other industries learned how to make
significant, sustainable improvements to their profitability by taking a holistic look at their overall
cost structure.
Pharmaceutical firms mainly focused on the high productivity, short lead times, required
quality and compliance standard of pharmaceutical manufacturing are often cited as limiting factors
in creating greater efficiency and many companies do better. Although the pharmaceutical industry
tends to view itself as unique-which in some ways it is – pharmaceutical companies can learn several
lessons from the companies that made the difficult but essential transformation to lean
manufacturing.
Pharma companies started from the false assumption that implementing lean principles and
processes would automatically lead to a reduction in overstaffing. In fact, lean processes only
address the lack of process optimization. In fact lean processes require leadership from the top level
of the company and at each subsequent level. Many companies initially believed that becoming a
lean manufacturer would take about two years. However, they discovered that lean manufacturing is
such a different method of operation that achieving full implementation takes four to five years but
lean is not just an activity it is a process.
Identifying the lean and bringing about the implementation in Pharma is easier said than
done. For any implementation – people, technology and processes that form the backbone of
business are receptive to the inherent change. In particular, the Pharma industries may limit the
degree to which this industry can adopt lean supply practices. Mostly, regulatory authorities do not
necessarily share the view that lean manufacturing and GMP standards as comparable.
First step towards the lean is to understand and accept the need for change. Despite its focus
on quality, it is the fact that pharmaceutical industry has failed to keep up with other industries in
terms of manufacturing efficiency and productivity, the main reason for this being high costs and
burden involved in revalidating any process change, even though changes were made in the spirit of
improvement.
In the past, pharmaceutical industry for which the principles of good manufacturing practice
are mandatory, has slowly been embracing lean manufacturing, in contrast to other sectors that
adopted it relatively quickly and successfully.
Therefore, this study emphasis on the finding out the scope and implementation of lean principles in
the pharmaceutical industry and thereby improve the productivity and operational efficiency.
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2.2 HYPOTHESIS OF THE STUDY:
Lean’s dual objectives, to reduce or eliminate waste and to create value, differ from cGMP
objective which is to ensure that controls are in place to deliver a safe and effective medicinal
product with good quality. In most cases, cGMP and lean management principles do overlap in the
pharmaceutical manufacturing environment. So, effective lean management principles to be
identified in the Pharma environment and utilised to improve the operational efficiency.
Industries are concern about the product quality with respect to cost and productivity. While
considering important research issues, it was found that there is a definite role for management in
quality control and quality assurance in implementing lean principles. Only if quality control and
quality assurance are strictly adopted, the management goals such as name of the company, sales and
profits could be achieved since due to effective quality systems the company would be producing
quality products.
At present, it is found that there is a lack of coordination between management function and
proper quality enforcement. In order to meet the strict quality requirements, management function
and quality enforcement have to be coordinated, have to move in tandem but not to be separated.
Scope and Implementation of Lean aspects in cGMP environment:
1) Existing quality system to be compared with Lean principles with respect to the optimization
of the processes and improve high productivity
2) Implementation of the Identified management principles to enhance short lead time and
improve product quality.
Sometimes it takes decades to implement 100% of the identified management principles.
Quality management system does not depend upon the capital investment and percentage of
operating expenditure on quality control / quality assurance.
As more and more of the lean implementation in the health care business is preceded this
way, the concept of a technology implementation to the customer and acceptance of the system will
be difficult but it takes long pathway to accept in the society.
2.3. RESEARCH METHODOLOGY:
STUDY AREA
SAMPLING PROCEDURE & DATA COLLECTION
FRAME WORK OF ANALYSIS
DATA ANALYSIS & INTERPRETATION
Research is a careful investigation or enquiry especially through search for new facts in any
branch of knowledge. Descriptive research has been used which involves surveys and fact findings.
2.3.1 Study Area: The study area refers only Hyderabad city, Andhra Pradesh.
2.3.2 Sampling Procedure & Data collection: The data were collected through different sampling
technique (refers to different ways of sampling approach) and Primary data through an
interview schedule was used as a tool for collecting the data.
2.3.3 Frame work of Analysis: Percentage Analysis.
2.3.4 Data Analysis and Interpretation.
Sampling Procedure: Sampling was carried out in Hyderabad city, Andhra Pradesh, INDIA. The
data was collected through various sources like Management Guides Websites (response through
internet) and Friends & Relatives, direct interviews.
During study, the data was collected as a whole and then segregated into various parts. Then, the
collected data was organized and reviewed. Relevant data were taken into consideration and few data
was kept for the reference purpose. Questionnaire with personnel interview conversation was done
much relevant to the study. The collected data was considered and tabulated in the final stage of the
5. International Journal of Management
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report. Further, Histogram graphical representation was made to interpret the results from the
collected data.
The current study reveals that the scope and lean implementation aspects
awareness within the employees were studied and represented below,
Table1. Available Scope of the
(Lean aspects are Very high productivity, Short Lead Time, Product
Sources of
Awareness
Above Manager level
No: of
respondents
Management guides 15
Websites 21
Books / Literatures 07
Business Process 03
Source: Primary data
Histogram representation: Figures Table1. S
the % awareness)
Figure 1:
0.0
50.0
Management
Guides Websites
32.61
Management Research and Development (IJMRD) ISSN 2248
9398 (Online) Volume 4, Number 1, January-March (2014)
report. Further, Histogram graphical representation was made to interpret the results from the
The current study reveals that the scope and lean implementation aspects
awareness within the employees were studied and represented below,
cope of the LEAN aspects in Pharma industry:
igh productivity, Short Lead Time, Product Quality value etc)
Above Manager level Below Manager level
of
respondents Percentage
(%)
No: of
respondents
32.61
45
45.65
29
15.22
13
6.52
05
Table1. Scope of LEAN aspects in Pharma industry.
Figure 1: Above Manager Level
Websites
Books /
Literatures Business
Process
45.65
15.22
6.52
Above Manager level
Research and Development (IJMRD) ISSN 2248-938X
report. Further, Histogram graphical representation was made to interpret the results from the
The current study reveals that the scope and lean implementation aspects along with
LEAN aspects in Pharma industry:
Quality value etc)
Below Manager level
Percentage
(%)
48.91
31.52
14.13
5.43
of LEAN aspects in Pharma industry. (Y axis refers
6. International Journal of Management
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Figure 2:
Inferences:
From the above data represented in the Figure
(45.65%) of the respondents became aware through
some of the management guidelines
Business processes shows (6.52%) with reducing trend. I
this shows the less percentage of (6.20%)
Below manager level Figure 2 shows that
aware through website and (48.91%) of the respondents through some of the management guidelines.
Other awareness areas like books and literature (14.13%) and Business processes shows (5.43%)
with reducing trend.
If we look into the area of business process, this shows the less percentage of (
the respondents. So, in current scenario of the competitive world, the
concentrating in the implementation of the lean management
implementation of the lean management principles is not the part of the business process.
The above data clearly indicates that the
sector in many ways but they are not
management tools and aspects.
Based on the data, pharmaceutical firms
to implement the lean management principles to enhance the operational e
productivity.
3. RESEARCH STUDY / SURVEY
INTERVIEW
About 6 pharmaceutical Industries were surveyed through Questionnaire / Direct interview
with the senior / middle level peoples in Hyderabad city, Andhra Pradesh to understand the Scope
and Implementation of lean management principles in the Pharma manufac
The following management aspects are identified which in turn improves the product quality. The
major aspects which are identified in cGMP environment as well as LEAN management principles
are
0.0
50.0
Management
Guides
48.91
Management Research and Development (IJMRD) ISSN 2248
9398 (Online) Volume 4, Number 1, January-March (2014)
Figure 2: Below Manager Level
above data represented in the Figure 1, Above manager level
%) of the respondents became aware through website and (32.61%) of the respondents through
guidelines. Other awareness areas like books and literature (1
with reducing trend. If we look into the area of
20%) from the respondents.
shows that data shows that (31.52%) of the respondents became
aware through website and (48.91%) of the respondents through some of the management guidelines.
Other awareness areas like books and literature (14.13%) and Business processes shows (5.43%)
we look into the area of business process, this shows the less percentage of (
in current scenario of the competitive world, the pharmaceutical firms
concentrating in the implementation of the lean management principles and methods.
implementation of the lean management principles is not the part of the business process.
clearly indicates that the pharmaceutical firms are growing in the Industrial
e not concentrating in the implementation of the
Based on the data, pharmaceutical firms should look into the scope of the management aspect
to implement the lean management principles to enhance the operational excellence
RESEARCH STUDY / SURVEY – THROUGH QUESTIONNAIRE / DIRECT
About 6 pharmaceutical Industries were surveyed through Questionnaire / Direct interview
with the senior / middle level peoples in Hyderabad city, Andhra Pradesh to understand the Scope
and Implementation of lean management principles in the Pharma manufacturing environment.
The following management aspects are identified which in turn improves the product quality. The
major aspects which are identified in cGMP environment as well as LEAN management principles
Websites
Books /
Literatures Business
Process
31.52
14.13
5.43
Below Manager Level
Research and Development (IJMRD) ISSN 2248-938X
Above manager level data shows that
%) of the respondents through
like books and literature (15.22%) and
business process,
that (31.52%) of the respondents became
aware through website and (48.91%) of the respondents through some of the management guidelines.
Other awareness areas like books and literature (14.13%) and Business processes shows (5.43%)
we look into the area of business process, this shows the less percentage of (5.43%) from
pharmaceutical firms were not
principles and methods. Hence, the
implementation of the lean management principles is not the part of the business process.
are growing in the Industrial
implementation of the lean aspects and
management aspect
xcellence with more
THROUGH QUESTIONNAIRE / DIRECT
About 6 pharmaceutical Industries were surveyed through Questionnaire / Direct interview
with the senior / middle level peoples in Hyderabad city, Andhra Pradesh to understand the Scope
turing environment.
The following management aspects are identified which in turn improves the product quality. The
major aspects which are identified in cGMP environment as well as LEAN management principles
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23
Very High Productivity, Robust Design, Manufacturing Capability, Validated process, Lead time,
Product Quality and Implementation of LEAN tools etc.
The above factors will immensely contribute to the Pharma industry in many ways for the
operational excellence with balanced productivity and Quality.
3.1 METHOD OF SURVEY:
To understand current scenario in the Pharma industry, the survey questionnaire was prepared
as per the research study requirement. Then, the selected Pharma firms were identified and visited.
The survey questionnaire was distributed to the middle level management peoples and taken back
with the comments. Further, the direct interview was performed at each senior level and information
was collected and scrutinized as per the study requirement.
This study includes many stages:
(a) Defining the Lean Practices based on criteria such as the inclusion of practices that workers
could observe, interact with and use on a daily basis;
(b) Defining the attributes for each practice, emphasizing the dimensions which were typical of
their implementation in Lean Practices in cGMP environments;
(c) Defining a set of evidence and sources of evidence for assessing the existence of each lean
attribute – the sources of evidence included direct observations, analysis of documents,
interviews and a feedback meeting to validate the assessment results with company
representatives.
This study supports the identification of improvement opportunities in cGMP performance
based on the analysis of their interfaces.
Some peoples were not properly effectively during the course interview but few suggestions were
taken as a part of research study.
Overall the responses / informations / suggestions received from the Pharma companies were found
to be adequate for the research study and tabulated in Table 2.
To identify the SCOPE and IMPLEMENTATION of LEAN ASPECTS in the PHARMA
INDUSTRY, the following survey and review was conducted in the various pharmaceutical firms
and outcomes are tabulated below,
Table 2 SURVEY RELATED to LEAN concepts and aspects in the Pharma manufacturing:
Survey Questionnaire Focussed on the
below aspects related to LEAN
COMPANIES SURVEYED FOR THE STUDY*
A B C D E F
% Acceptance of LEAN implementation 75 50 75 50 75 25
% Robust Design & Process 25 50 50 50 25 50
% Manufacturing capability 75 50 75 50 75 75
% Very High Productivity 75 50 75 50 75 50
% Short Lead Time 25 25 25 50 25 50
% Validated process 25 50 25 50 25 50
% Product Quality 75 50 75 50 75 75
% Current level of Implementation of
LEAN
25 25 25 25 50 25
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Note:
• * ABCDEF refers to the various Pharmaceutical companies surveyed around Hyderabad
city, Andhra Pradesh.
• % refers to the Average data: Scale used in the Survey Questionnaire relates to the current
quality system ,
Very Less – 25%, Moderate – 50%, Good – 75% Excellent – 100%
Source: Primary data, % calculated from 100%, hence data collected for comparison only.
Note: The research survey (questionnaire / discussion) was conducted in the pharmaceutical
companies with the Quality related peoples / teams (senior / middle level) in the various
departments. Direct interview / discussion are conducted with questionnaire (above aspects) with 6
out of selected 11 medium and largest pharmaceutical firms. (Name of the surveyed organization
names not mentioned, but supporting questionnaire data is available). Source: Primary data, %
calculated from survey.
Information about the surveyed companies in Hyderabad:
A) XXXX Pharma limited:
* Formulation Unit
* Manufacture of the solid oral dosage forms e.g. Tablets
* Facility approved by USFDA, ISO 9001:2008 standards
B) XXXX Pharma limited:
* Research & Development & Formulation Unit
* Manufacture of the General category & solid oral dosage forms e.g. Tablets, capsules
* GMP Facility
C) XXXX India limited:
* Formulation Unit
* Manufacture of the solid oral dosage forms e.g. Tablets
* Facility approved by USFDA standards
D) XXXX Labs limited:
* Formulation Unit
* Manufacture of the Eye Drops / Injectables
* Facility approved by USFDA standards
E) Dr. XXXX Laboratories ltd:
* Formulation Unit
* Manufacture of the Injections & R&D
* Facility approved by USFDA, MHRA standards
F) XXXX laboratories limited:
* Formulation Unit
* Manufacture of the solid oral dosage forms e.g. Tablets, Capsules
* Facility approved ISO 9001:2008 standards
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DATA INTERPRETATION:
SCOPE FOR IMPLEMENTATION OF LEAN PRINCIPLES IN PHARMA,
Figure 3: Acceptance of LEAN Aspects
Figure 4: Robust Design & Process
Figure 5: Manufacturing Capability
75
50
75
50
75
25
0 20 40 60 80 100
A
B
C
D
E
F
Acceptance of LEAN aspects
25
50
50
50
25
50
0 20 40 60 80 100
A
B
C
D
E
F
Robust Design & Process
25
50
50
50
25
50
0 20 40 60 80 100
A
B
C
D
E
F
Manufacturing Capability
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Figure 6: Very High Productivity
Figure 7: Short Lead time
Figure 8: Validated Process
75
50
75
50
75
50
0 20 40 60 80 100
A
B
C
D
E
F
Very High Productivity
25
25
25
50
25
50
0 20 40 60 80 100
A
B
C
D
E
F
Short Lead Time
25
50
25
50
25
50
0 20 40 60 80 100
A
B
C
D
E
F
Validated process
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Figure 9: Product Quality
Figure 10: Current level of implementation LEAN
3.2 Results / Discussion from the Outcome of Research Survey:
From the above data represented in the graphs, it shows that many of the Pharmaceutical
industries follow the cGMP prospective but there was lot of scope for the implementation of the
LEAN management principles. Till today, the Pharmaceutical firms were mainly concentrating in the
core aspect of ensuring the Product Quality through product development. Based on the initial survey
/ discussion, it was observed that there was lack of awareness about the lean principles in the various
pharmaceutical industries. Most of the Pharma industries are concerned about the product quality
with respect to cost and productivity.
INFERENCE FROM THE ABOVE SURVEY: LEAN implementation (around 25% only)
IDENTIFICATION of the areas + IMPLEMENTATION OF LEAN = IMPROVED
PRODUCT QUALITY
Effective quality management systems for the companies are the integral part of the company
because it enables them to provide quality products. Based on the survey data analysis, it was
observed that most of the companies are focus in ensuring the product manufacturing. Some of the
companies are in robust design and validated process but existing process validation data helps them
in improving product quality.
75
50
75
50
75
75
0 20 40 60 80 100
A
B
C
D
E
F
Product Quality
25
25
25
25
50
25
0 20 40 60 80 100
A
B
C
D
E
F
Current level of Implementation of LEAN
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Core lean aspects like Robust design; validated process, Lead time like lean principles are not much
implemented and improved. The main cause for the same is due to the lack of training and business
process was not clearly defined.
The most important fact to be viewed in the survey was the lack of understanding and weak
implementation of the lean practices implementation around 25% in the Pharmaceutical sectors.
Most of the pharmaceutical companies focus on the product quality thereby looking into the
other aspects like reducing the cost, creating value etc. The management should realize that effective
product quality will be achieved only through the effective quality management system through the
implementation of the lean methods and Practices. In current scenario, many companies are
following some process steps to achieve the best quality products. Based on the survey it was clearly
understood that identified lean principles or methods to be implemented in cGMP environment with
proper guidance to improve operational excellence to ensure that system will yield the desired
results.
4. CONCLUSION
Change is inevitable and the only constant in today’s world. Every Pharma industry has to
implement the quality management systems in line with the management principles and sustain in the
ever changing environment. Pharmaceutical field is no exception to this.
During the course of the study, it was found that there was a lot of scope for the implementation of
the lean management principle in cGMP environment which was not clearly identified and
implemented.
1. Based on the research study & data, it was clearly states that in the recent years more focus given
to the product quality area. Moreover, some % of people was not aware completely about the
scope of lean method and nature of the impact. But, if we look into the % business process for
the awareness of the lean management it was found to be less and this would be the area for the
scope of improvement.
2. Many of the people in the industry were not involved in the quality system implementation
activity. Based on the management guidelines and training activities most of the lean principles
to be implemented. Further, the higher management people are not completely transparent on
their policies and procedures to implement the lean management principles in the cGMP
environment.
3. Based on this research study, primary data review & research survey of the Pharma we have
derived that employee knowledge on the lean management to be improved and senior level
people should implement the lean management principles. A well-designed LEAN
implementation enhances the reliability of product quality.
The following lean management principles derived from this research study are represented below
which are to be implemented effectively in the Pharma environment to enhance the High
productivity, short lead time with operational excellence and improve product quality.
1) Identify and Implement the LEAN aspects which Create value and reduce waste
2) Implement Lean methods effectively and slowly
3) Ensure robust design
4) Implement quality systems in line with LEAN
5) Validated process
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Outcome of the Research Study
A Continuous effort is essential to identify and implement the LEAN practices and principles
in the Pharmaceutical sectors for the manufacturing of the pharmaceutical products to ensure that the
product quality with high productivity in short lead time.
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