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 document discusses a research project analyzing the use and effectiveness of Total Quality Management (TQM) approaches in the German food industry.
- A survey of 442 food industry companies in Germany was conducted to assess the current status of TQM implementation based on the EFQM Excellence Model, which defines nine key areas.
- The results showed that companies have successfully implemented some TQM requirements like reducing environmental impacts and ensuring organizational structures. However, other areas like collecting employee feedback and communicating societal impacts need improvement.
- Statistical analysis found a positive correlation between TQM implementation and long-term business success, though companies ranked the impact of different TQM areas differently than the statistical results.
The study of scope and implementation of lean aspectsprjpublications
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.
Impact of Total Quality Management (TQM) on Operational Performance of Ethiop...Dr. Amarjeet Singh
The purpose of this study is to examine the impact of
TQM system on the operational performance of the
pharmaceutical manufacturing companies operating in
Ethiopia. Data for this study is collected using selfadministered questionnaires. The survey is carried out on 65
respondents drawn from 13 companies. Out of 65
questionnaires distributed among these companies, a total of
57 got returned. Through comprehensive literature review,
seven critical success factors of TQM that are relevant to the
pharmaceutical industry are identified. Correlation &
regression analyses are used to investigate the relationship
between TQM variables on the one side and common
operational performance measures (Quality, Cost, and
Delivery & Flexibility to volume) on the other side. The
Correlation analysis reveals that there is strong relationship
between TQM practices and operational performance among
the pharmaceutical manufacturing companies. The outcome of
regression analysis indicates that customer focus, process
management, product design and people management have
significant contribution to at least one of the operational
performance measures. Top Management’s support,
suppliers’ quality management and continuous improvement
do not appear to contribute to higher levels of performance.
This study offers pharmaceutical companies and their
managers a better understanding of the relationship and
impact that some of TQM elements have on the performance
of their operations. Thus managers will get an opportunity to
take better & more effective decisions in the implementation of
TQM. This study can also guide organizations to prioritize the
implementation of TQM based on the strategic importance of
performance measures needed by them. The choice
performance measure is based on the perceptions of managers
and therefore, generalization of the observations may be made
with caution.
This document summarizes a study that conducted a gap analysis to assess Indian seafood exporting firms' readiness to implement total quality management (TQM). The study found the largest gaps were in the areas of using statistical process control tools (66.7% gap), benchmarking (65.6%), top management commitment (56.25%), and customer focus (48.1%). Top management was generally supportive of quality programs but lacked awareness of TQM tools and quality incentives for workers. Supplier quality management also showed a gap, though raw material quality was usually satisfactory. Few firms conducted customer satisfaction surveys. Overall the analysis revealed several areas that would need to be improved for firms to fully adopt a TQM system.
Medical Affairs, as a function, sits at a crossroads in the pharmaceutical industry. The department is expected to act as a bridge between the commercial and scientific arms of an organization. Medical Affairs is further tasked with being the conduit of information between the company and external stakeholders, bringing efficacy and safety data to the medical community as well as gathering insights from the medical community to share internally. All responsibilities must be undertaken while keeping in mind strict regulatory controls and ensuring that medical data are interpreted appropriately.
ISR has designed this report to be used as a benchmarking tool for companies to compare their Medical Affairs functions to those of Top 50 pharmaceutical organizations.
See more: http://bit.ly/medaffairs
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.
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.
Dear all,
I have tried putting down my view-points on benefits of Project Management system in Pharmaceutical Industry...
Please let me know what do you think.
Regards,
Megha Thakkar
- The document discusses a research project analyzing the use and effectiveness of Total Quality Management (TQM) approaches in the German food industry.
- A survey of 442 food industry companies in Germany was conducted to assess the current status of TQM implementation based on the EFQM Excellence Model, which defines nine key areas.
- The results showed that companies have successfully implemented some TQM requirements like reducing environmental impacts and ensuring organizational structures. However, other areas like collecting employee feedback and communicating societal impacts need improvement.
- Statistical analysis found a positive correlation between TQM implementation and long-term business success, though companies ranked the impact of different TQM areas differently than the statistical results.
The study of scope and implementation of lean aspectsprjpublications
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.
Impact of Total Quality Management (TQM) on Operational Performance of Ethiop...Dr. Amarjeet Singh
The purpose of this study is to examine the impact of
TQM system on the operational performance of the
pharmaceutical manufacturing companies operating in
Ethiopia. Data for this study is collected using selfadministered questionnaires. The survey is carried out on 65
respondents drawn from 13 companies. Out of 65
questionnaires distributed among these companies, a total of
57 got returned. Through comprehensive literature review,
seven critical success factors of TQM that are relevant to the
pharmaceutical industry are identified. Correlation &
regression analyses are used to investigate the relationship
between TQM variables on the one side and common
operational performance measures (Quality, Cost, and
Delivery & Flexibility to volume) on the other side. The
Correlation analysis reveals that there is strong relationship
between TQM practices and operational performance among
the pharmaceutical manufacturing companies. The outcome of
regression analysis indicates that customer focus, process
management, product design and people management have
significant contribution to at least one of the operational
performance measures. Top Management’s support,
suppliers’ quality management and continuous improvement
do not appear to contribute to higher levels of performance.
This study offers pharmaceutical companies and their
managers a better understanding of the relationship and
impact that some of TQM elements have on the performance
of their operations. Thus managers will get an opportunity to
take better & more effective decisions in the implementation of
TQM. This study can also guide organizations to prioritize the
implementation of TQM based on the strategic importance of
performance measures needed by them. The choice
performance measure is based on the perceptions of managers
and therefore, generalization of the observations may be made
with caution.
This document summarizes a study that conducted a gap analysis to assess Indian seafood exporting firms' readiness to implement total quality management (TQM). The study found the largest gaps were in the areas of using statistical process control tools (66.7% gap), benchmarking (65.6%), top management commitment (56.25%), and customer focus (48.1%). Top management was generally supportive of quality programs but lacked awareness of TQM tools and quality incentives for workers. Supplier quality management also showed a gap, though raw material quality was usually satisfactory. Few firms conducted customer satisfaction surveys. Overall the analysis revealed several areas that would need to be improved for firms to fully adopt a TQM system.
Medical Affairs, as a function, sits at a crossroads in the pharmaceutical industry. The department is expected to act as a bridge between the commercial and scientific arms of an organization. Medical Affairs is further tasked with being the conduit of information between the company and external stakeholders, bringing efficacy and safety data to the medical community as well as gathering insights from the medical community to share internally. All responsibilities must be undertaken while keeping in mind strict regulatory controls and ensuring that medical data are interpreted appropriately.
ISR has designed this report to be used as a benchmarking tool for companies to compare their Medical Affairs functions to those of Top 50 pharmaceutical organizations.
See more: http://bit.ly/medaffairs
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.
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.
Dear all,
I have tried putting down my view-points on benefits of Project Management system in Pharmaceutical Industry...
Please let me know what do you think.
Regards,
Megha Thakkar
Technology is disrupting the process behind drug development. Growing realization that current clinical trial strategies are not sustainable or feasible means one thing - change. But, where do pharmaceutical companies go from here? An integrated clinical trial ecosystem will arise through leveraging emerging business technologies. But, are companies prepared to take advantage?
Chemometrics Pharmacometrics Econometrics of QbD Swiss Pharma-6 2012Ajaz Hussain
The document discusses the potential role of mathematical modeling tools in improving regulatory communications on quality by design in the pharmaceutical industry. Specifically, it argues that chemometrics, pharmacometrics, and econometrics can provide objective ways to integrate scientific data across the product lifecycle in order to facilitate more risk-based regulatory decisions. Development reports that utilize chemometrics to predict critical quality attributes and verify predictions, along with explanations connecting these attributes to clinical outcomes, can give regulators a means to evaluate scientific understanding. Econometric modeling of manufacturing practices and their impact on product variability may allow facilities to be categorized by risk level. This integrated approach using multiple disciplines can help realize the goals of quality by design.
ISO 22000 is an internationally recognized food safety management standard that combines Hazard Analysis and Critical Control Point (HACCP) principles with other food safety requirements. The standard helps organizations demonstrate their ability to control food safety hazards at all levels of the food supply chain. Key benefits of ISO 22000 certification include improved food safety, quality assurance, management and communication, cost reductions from avoiding recalls, and an enhanced reputation.
This document summarizes McKinsey's perspectives on improving pharmaceutical R&D productivity. It finds that while scientific innovation is important, better management of costs, speed, and decision making can significantly increase returns. Modeling shows the average small molecule's return is below cost of capital. Improving management in costs (e.g. reducing failures' costs), speed (e.g. accelerating programs 18 months), and decision making (e.g. removing weak programs earlier) could boost the average small molecule's IRR from 7.5% to 13%, surpassing cost of capital. Better management offers a path to reinventing invention without radical changes to the scientific model.
quality management systems: Total quality management & Quality by designDr Ajay Kumar Tiwari
Total quality management (TQM) and quality by design (QbD) are important approaches for maintaining quality in the pharmaceutical industry. TQM focuses on continuous improvement and prevention of defects rather than detection. It involves strategic commitment, employee involvement, and precise techniques. QbD is a systematic approach that includes prior product and process understanding to design quality into the manufacturing process from the beginning. The main objectives of QbD are increasing efficiency, enhancing product quality, and avoiding regulatory issues. It involves defining quality target profiles, identifying critical quality attributes, assessing risks, and establishing control strategies.
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.
The document discusses the role and responsibilities of Medical Affairs departments within pharmaceutical companies. It describes how Medical Affairs operates medical information functions, provides insights from research to brand teams, cultivates relationships with key opinion leaders, and oversees publication planning and medical writing. Medical Affairs contributes to promotional review and provides market intelligence. The functions of Medical Affairs are organized globally and sometimes by business unit or therapeutic area at the local level. Key areas of specialization within Medical Affairs include medical services, medical research, and medical liaisons.
This document provides guidance on common GMP compliance observations that may be found during drug manufacturing inspections and how to properly document these observations in inspection reports. It outlines an integrated six-system model for inspections covering quality, facilities, materials, production, packaging and labeling, and laboratory control systems. Potential observations are grouped into categories like vague procedures, failure to investigate out-of-specification results, lack of standard operating procedures, inadequate cleaning procedures, and lack of in-process monitoring. The goal is to help inspectors comprehensively evaluate GMP compliance and write reports in a clear, consistent and credible manner.
A workshop presentation for Medical Affairs Strategic Summit West held in San Diego on September 23, 2019. The workshop covered the following learning objectives:
* Understand the factors involved in selecting and prioritizing indications
* Understand the importance of strategic market segmentation
* Understand how Medical Affairs can be involved in the process of new product planning
The document summarizes the strategic outsourcing of clinical trials to contract research organizations (CROs) with a focus on India and China as growing markets. It discusses the reasons for outsourcing clinical trials, including rising costs and complexity. CROs provide expertise and services to sponsors at lower costs than sponsors conducting all research internally. India and China offer lower costs than Western countries and have large patient populations and clinical trial infrastructure to support outsourced research. Both countries have seen significant growth in their CRO industries in recent years.
This document summarizes a research study on green supply chain management (GSCM) practices in the pharmaceutical industry in India. The study examines how external pressures and internal factors influence GSCM adoption. It also analyzes the relationships between GSCM practices, environmental performance, operational performance, and financial performance. Survey data was collected from 27 pharmaceutical companies in India that have ISO 14001 certification. Statistical analysis using exploratory factor analysis and structural equation modeling was conducted to test hypotheses about drivers of GSCM practices and their impact on organizational performance. The results indicate that pharmaceutical companies have adopted GSCM practices in response to environmental regulations and market pressures, and that these practices improve environmental, operational and financial performance.
This document provides guidance on implementing a quality system approach to ensure compliance with cGMP regulations in a harmonized manner consistent with modern pharmaceutical practices. It outlines key concepts of a quality system, including design quality into products, risk-based quality management, change control, periodic quality reviews, supplier qualification, calibration, validation, complaint handling and recalls. The document refers to FDA's six systems inspection model and outlines four major factors of a quality systems model: management responsibilities, resource management, process management and quality planning. The goal is to help manufacturers understand and implement modern science-based quality systems and risk management.
Medical Affairs Resources, Structures, and Trends (UPDATE) - Report SummaryBest Practices
The Update to the wildly popular Medical Affairs Resources, Structures, and Trends research from 2009 is ready! Contains linear data and new segmentation for emerging markets.
Charged with building and maintaining physician relationships, pharmaceutical Medical Affairs organizations typically oversee several important functions -- including publications, KOL programs, grants and medical education (CME) -- that have been impacted in recent years by a call for increased transparency. As such, forward-looking biopharmaceutical executives are beginning to evaluate Medical Affairs operations to ensure that the vital organization is appropriately structured and resourced to operate effectively in the current environment.
This Best Practices, LLC study explores how U.S. and global biopharmaceutical companies are structuring and managing their Medical Affairs organizations today. The study also examines recent trends in budget and staffing resources, key challenges and top success factors for the function.
The report is based on the insights of 68 Medical Affairs executives and managers at 50 leading global companies. The benchmark class in this study consists of a Mature Markets and Emerging Markets Segment. The Mature Market Segment includes 41 participants from pharma and 12 device respondents. The Emerging Markets Segment consists of 15 participants working in India, China, Brazil, and Turkey.
This document proposes a collaborative study between DRAP and medical/pharmacy schools in Pakistan to analyze drug brand names and promotional claims to reduce medication errors. The study would have students review 20 drug names for confusion potential. It would examine spelling, pronunciation, appearance in writing, product characteristics, and promotional material claims. The goal is to identify sources of ambiguity to minimize errors in prescribing, dispensing, and administering medications.
Benchmarking Quality: How Medical Device and Diagnostics Companies Manage Cos...Best Practices
Medical device and diagnostics companies spend millions to ensure their products meet quality standards at every stage of the product lifecycle, from R&D to post-market activity. Facing tight budgets and escalating regulations, quality leaders are preparing to shift resources, automate and outsource activities, develop and retain key talent, and build business plans that justify their budgets.
This Best Practices, LLC, report delivers comprehensive survey benchmarks on how medical device companies are defining and allocating Quality spend, identifying factors that impact spending levels, and investing in future mission-critical Quality activities.
Quality leaders can use the evidence-based metrics and insights for Quality spending, staffing, change request levels, outsourcing, software quality, inspections, lab testing, complaint management, trend insights and more.
Know about Contract manufacturing of pharma products marketactizapharma
Here's some discuss and news regarding actizapharma which are working on the contract pharmaceutical production worldwide. They proficient enough to customize the entire range of medicines, to meet client’s requirements.
Outsourcing in Drug Development: The Contract Research (Clinical Trial) MarketMarketResearch.com
The cost and time of developing and bringing a drug to market is over $1.3 billion and often takes as long as 15 years, if not longer. Because of this, major pharmaceutical marketers continue to outsource stages of development, and over the years Kalorama Information has observed this process. In past editions of our outsourcing market studies, we found that outsourcing moved from "should" to "must." for manufacturers. This trend has only continued in the past two years. Contract Research Organizations (CROs) and other entities can expect growing demand for their services.
The demand for new drugs remains unabated, but the cost and need to bring those drugs to market is ever-increasing and intensifying. A key cost driver is the large number of failures during the expensive clinical trial phases. Driven by pressures to reduce costs, companies are increasingly implementing outsourcing strategies to increase revenues through faster drug development. By decreasing their in-house facilities and staff, and outsourcing more of their R&D functions, pharmaceutical and biotechnology companies are reshaping the drug development services industry.
Kalorama Information's Outsourcing in Drug Development: The Contract Research (Clinical Trial) Market is the third edition of this study of the drivers for outsourcing drug development, the companies involved in this market and the opportunity for revenues.
Pathways to Efficient Drug Development - Advances in Modeling and Simulation ...ReportsnReports
The report examines ways the pharmaceutical industry is seeking to improve efficiency in drug development given rising costs and other challenges. It explores areas like precompetitive research collaboration, use of modeling and simulation in clinical trials, and novel business models. The 66-page report analyzes these topics based on primary interviews and secondary research to identify key innovations and their potential to help companies develop drugs more effectively.
Outsourcing of Regulatory Affairs Tasks in PharmaceuticalAnu Gummerus
The document summarizes a study on the outsourcing of regulatory affairs tasks in the pharmaceutical industry in Europe. The key findings are:
1) The most commonly outsourced regulatory task was translation of product information texts (75% of respondents).
2) The main reason for outsourcing regulatory affairs tasks to Contract Research Organizations (CROs) was the heavy workload in companies' regulatory departments. Ensuring outsourcing is cost-effective was also a key factor.
3) When choosing a CRO partner, companies valued the CRO's experience and knowledge most highly. Personal contacts with the CRO were also often mentioned as important in selecting a partner.
Preethi S. Asooriar is a test engineer with 4 years of experience at Infosys. She has strong technical skills in testing methods like manual testing, functional testing, and regression testing. She is proficient with tools like Visual Studio, MS Office, and testing languages like Java, C/C++, HTML/CSS, and MySQL. Her work experience includes testing healthcare claims processing and an online provider directory, as well as customizing and submitting health plans for a central product library. Her responsibilities included requirement analysis, test case preparation, execution, defect management, and status reporting.
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Technology is disrupting the process behind drug development. Growing realization that current clinical trial strategies are not sustainable or feasible means one thing - change. But, where do pharmaceutical companies go from here? An integrated clinical trial ecosystem will arise through leveraging emerging business technologies. But, are companies prepared to take advantage?
Chemometrics Pharmacometrics Econometrics of QbD Swiss Pharma-6 2012Ajaz Hussain
The document discusses the potential role of mathematical modeling tools in improving regulatory communications on quality by design in the pharmaceutical industry. Specifically, it argues that chemometrics, pharmacometrics, and econometrics can provide objective ways to integrate scientific data across the product lifecycle in order to facilitate more risk-based regulatory decisions. Development reports that utilize chemometrics to predict critical quality attributes and verify predictions, along with explanations connecting these attributes to clinical outcomes, can give regulators a means to evaluate scientific understanding. Econometric modeling of manufacturing practices and their impact on product variability may allow facilities to be categorized by risk level. This integrated approach using multiple disciplines can help realize the goals of quality by design.
ISO 22000 is an internationally recognized food safety management standard that combines Hazard Analysis and Critical Control Point (HACCP) principles with other food safety requirements. The standard helps organizations demonstrate their ability to control food safety hazards at all levels of the food supply chain. Key benefits of ISO 22000 certification include improved food safety, quality assurance, management and communication, cost reductions from avoiding recalls, and an enhanced reputation.
This document summarizes McKinsey's perspectives on improving pharmaceutical R&D productivity. It finds that while scientific innovation is important, better management of costs, speed, and decision making can significantly increase returns. Modeling shows the average small molecule's return is below cost of capital. Improving management in costs (e.g. reducing failures' costs), speed (e.g. accelerating programs 18 months), and decision making (e.g. removing weak programs earlier) could boost the average small molecule's IRR from 7.5% to 13%, surpassing cost of capital. Better management offers a path to reinventing invention without radical changes to the scientific model.
quality management systems: Total quality management & Quality by designDr Ajay Kumar Tiwari
Total quality management (TQM) and quality by design (QbD) are important approaches for maintaining quality in the pharmaceutical industry. TQM focuses on continuous improvement and prevention of defects rather than detection. It involves strategic commitment, employee involvement, and precise techniques. QbD is a systematic approach that includes prior product and process understanding to design quality into the manufacturing process from the beginning. The main objectives of QbD are increasing efficiency, enhancing product quality, and avoiding regulatory issues. It involves defining quality target profiles, identifying critical quality attributes, assessing risks, and establishing control strategies.
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.
The document discusses the role and responsibilities of Medical Affairs departments within pharmaceutical companies. It describes how Medical Affairs operates medical information functions, provides insights from research to brand teams, cultivates relationships with key opinion leaders, and oversees publication planning and medical writing. Medical Affairs contributes to promotional review and provides market intelligence. The functions of Medical Affairs are organized globally and sometimes by business unit or therapeutic area at the local level. Key areas of specialization within Medical Affairs include medical services, medical research, and medical liaisons.
This document provides guidance on common GMP compliance observations that may be found during drug manufacturing inspections and how to properly document these observations in inspection reports. It outlines an integrated six-system model for inspections covering quality, facilities, materials, production, packaging and labeling, and laboratory control systems. Potential observations are grouped into categories like vague procedures, failure to investigate out-of-specification results, lack of standard operating procedures, inadequate cleaning procedures, and lack of in-process monitoring. The goal is to help inspectors comprehensively evaluate GMP compliance and write reports in a clear, consistent and credible manner.
A workshop presentation for Medical Affairs Strategic Summit West held in San Diego on September 23, 2019. The workshop covered the following learning objectives:
* Understand the factors involved in selecting and prioritizing indications
* Understand the importance of strategic market segmentation
* Understand how Medical Affairs can be involved in the process of new product planning
The document summarizes the strategic outsourcing of clinical trials to contract research organizations (CROs) with a focus on India and China as growing markets. It discusses the reasons for outsourcing clinical trials, including rising costs and complexity. CROs provide expertise and services to sponsors at lower costs than sponsors conducting all research internally. India and China offer lower costs than Western countries and have large patient populations and clinical trial infrastructure to support outsourced research. Both countries have seen significant growth in their CRO industries in recent years.
This document summarizes a research study on green supply chain management (GSCM) practices in the pharmaceutical industry in India. The study examines how external pressures and internal factors influence GSCM adoption. It also analyzes the relationships between GSCM practices, environmental performance, operational performance, and financial performance. Survey data was collected from 27 pharmaceutical companies in India that have ISO 14001 certification. Statistical analysis using exploratory factor analysis and structural equation modeling was conducted to test hypotheses about drivers of GSCM practices and their impact on organizational performance. The results indicate that pharmaceutical companies have adopted GSCM practices in response to environmental regulations and market pressures, and that these practices improve environmental, operational and financial performance.
This document provides guidance on implementing a quality system approach to ensure compliance with cGMP regulations in a harmonized manner consistent with modern pharmaceutical practices. It outlines key concepts of a quality system, including design quality into products, risk-based quality management, change control, periodic quality reviews, supplier qualification, calibration, validation, complaint handling and recalls. The document refers to FDA's six systems inspection model and outlines four major factors of a quality systems model: management responsibilities, resource management, process management and quality planning. The goal is to help manufacturers understand and implement modern science-based quality systems and risk management.
Medical Affairs Resources, Structures, and Trends (UPDATE) - Report SummaryBest Practices
The Update to the wildly popular Medical Affairs Resources, Structures, and Trends research from 2009 is ready! Contains linear data and new segmentation for emerging markets.
Charged with building and maintaining physician relationships, pharmaceutical Medical Affairs organizations typically oversee several important functions -- including publications, KOL programs, grants and medical education (CME) -- that have been impacted in recent years by a call for increased transparency. As such, forward-looking biopharmaceutical executives are beginning to evaluate Medical Affairs operations to ensure that the vital organization is appropriately structured and resourced to operate effectively in the current environment.
This Best Practices, LLC study explores how U.S. and global biopharmaceutical companies are structuring and managing their Medical Affairs organizations today. The study also examines recent trends in budget and staffing resources, key challenges and top success factors for the function.
The report is based on the insights of 68 Medical Affairs executives and managers at 50 leading global companies. The benchmark class in this study consists of a Mature Markets and Emerging Markets Segment. The Mature Market Segment includes 41 participants from pharma and 12 device respondents. The Emerging Markets Segment consists of 15 participants working in India, China, Brazil, and Turkey.
This document proposes a collaborative study between DRAP and medical/pharmacy schools in Pakistan to analyze drug brand names and promotional claims to reduce medication errors. The study would have students review 20 drug names for confusion potential. It would examine spelling, pronunciation, appearance in writing, product characteristics, and promotional material claims. The goal is to identify sources of ambiguity to minimize errors in prescribing, dispensing, and administering medications.
Benchmarking Quality: How Medical Device and Diagnostics Companies Manage Cos...Best Practices
Medical device and diagnostics companies spend millions to ensure their products meet quality standards at every stage of the product lifecycle, from R&D to post-market activity. Facing tight budgets and escalating regulations, quality leaders are preparing to shift resources, automate and outsource activities, develop and retain key talent, and build business plans that justify their budgets.
This Best Practices, LLC, report delivers comprehensive survey benchmarks on how medical device companies are defining and allocating Quality spend, identifying factors that impact spending levels, and investing in future mission-critical Quality activities.
Quality leaders can use the evidence-based metrics and insights for Quality spending, staffing, change request levels, outsourcing, software quality, inspections, lab testing, complaint management, trend insights and more.
Know about Contract manufacturing of pharma products marketactizapharma
Here's some discuss and news regarding actizapharma which are working on the contract pharmaceutical production worldwide. They proficient enough to customize the entire range of medicines, to meet client’s requirements.
Outsourcing in Drug Development: The Contract Research (Clinical Trial) MarketMarketResearch.com
The cost and time of developing and bringing a drug to market is over $1.3 billion and often takes as long as 15 years, if not longer. Because of this, major pharmaceutical marketers continue to outsource stages of development, and over the years Kalorama Information has observed this process. In past editions of our outsourcing market studies, we found that outsourcing moved from "should" to "must." for manufacturers. This trend has only continued in the past two years. Contract Research Organizations (CROs) and other entities can expect growing demand for their services.
The demand for new drugs remains unabated, but the cost and need to bring those drugs to market is ever-increasing and intensifying. A key cost driver is the large number of failures during the expensive clinical trial phases. Driven by pressures to reduce costs, companies are increasingly implementing outsourcing strategies to increase revenues through faster drug development. By decreasing their in-house facilities and staff, and outsourcing more of their R&D functions, pharmaceutical and biotechnology companies are reshaping the drug development services industry.
Kalorama Information's Outsourcing in Drug Development: The Contract Research (Clinical Trial) Market is the third edition of this study of the drivers for outsourcing drug development, the companies involved in this market and the opportunity for revenues.
Pathways to Efficient Drug Development - Advances in Modeling and Simulation ...ReportsnReports
The report examines ways the pharmaceutical industry is seeking to improve efficiency in drug development given rising costs and other challenges. It explores areas like precompetitive research collaboration, use of modeling and simulation in clinical trials, and novel business models. The 66-page report analyzes these topics based on primary interviews and secondary research to identify key innovations and their potential to help companies develop drugs more effectively.
Outsourcing of Regulatory Affairs Tasks in PharmaceuticalAnu Gummerus
The document summarizes a study on the outsourcing of regulatory affairs tasks in the pharmaceutical industry in Europe. The key findings are:
1) The most commonly outsourced regulatory task was translation of product information texts (75% of respondents).
2) The main reason for outsourcing regulatory affairs tasks to Contract Research Organizations (CROs) was the heavy workload in companies' regulatory departments. Ensuring outsourcing is cost-effective was also a key factor.
3) When choosing a CRO partner, companies valued the CRO's experience and knowledge most highly. Personal contacts with the CRO were also often mentioned as important in selecting a partner.
Preethi S. Asooriar is a test engineer with 4 years of experience at Infosys. She has strong technical skills in testing methods like manual testing, functional testing, and regression testing. She is proficient with tools like Visual Studio, MS Office, and testing languages like Java, C/C++, HTML/CSS, and MySQL. Her work experience includes testing healthcare claims processing and an online provider directory, as well as customizing and submitting health plans for a central product library. Her responsibilities included requirement analysis, test case preparation, execution, defect management, and status reporting.
reciclatge-- Created using PowToon -- Free sign up at http://www.powtoon.com/ -- Create animated videos and animated presentations for free. PowToon is a free tool that allows you to develop cool animated clips and animated presentations for your website, office meeting, sales pitch, nonprofit fundraiser, product launch, video resume, or anything else you could use an animated explainer video. PowToon's animation templates help you create animated presentations and animated explainer videos from scratch. Anyone can produce awesome animations quickly with PowToon, without the cost or hassle other professional animation services require.
The document discusses personality development and provides tips for improving personality. It defines personality as an individual's distinctive pattern of attitudes and behaviors. Some tips for developing a good personality include being kind, not being loud, having a sense of humor, and remembering that personality is not about looks. Additional advice includes not comparing oneself to others, focusing on positivity, avoiding gossip, setting goals, managing time well, serving others, developing leadership skills, and working as part of a team. The document also provides suggestions for how to get people to like you, such as showing genuine interest in others and being a good listener.
Organizasyonel teoride, Organizasyonel değişim süreçlerinde uygulanabilecek bir çok yöntem ve prensip mevcut. Bunlardan John Kotter a ait 8 adımlı değişim yönetimi, bana kalırsa en kapsamlı ve etkili olanı.
El documento presenta un plan de lección sobre introducción a los planes de emergencia y evacuación. El objetivo principal es que los participantes sean capaces de identificar qué es un plan de emergencia, listar sus partes y los factores de riesgo. La lección cubrirá qué es un plan de emergencia, dónde se debe implementar, y los factores de riesgo como la densidad de ocupación y características de los ocupantes.
Starbucks Corporation is an American global coffee company that is the largest coffeehouse company in the world. It has over 20,000 stores in 64 countries. Starbucks primarily sells hot and cold beverages, coffee beans, pastries and snacks. The majority of Starbucks' revenue comes from company-owned retail stores. Starbucks is looking to expand internationally through licensing and increasing its consumer packaged goods business. One of its main strengths is its strong brand loyalty and sophisticated loyalty program.
The document outlines the key HR goals and objectives for 2013, including addressing the war for talents, supporting innovations, implementing performance-driven compensation, developing talent, and establishing lean HR processes. It also discusses the economic outlook and need for efficiency. The goals are aimed at gaining a competitive advantage and supporting the business strategy. Future areas of focus include continuing pressure to automate non-value added HR work and simplify processes, as well as developing skills for in-demand technical jobs.
The study of scope and implementation of lean aspectsprj_publication
The document discusses the scope and implementation of lean aspects in the pharmaceutical industry. It begins by noting that pharmaceutical companies face challenges like rising costs and need to deliver quality products quickly within a competitive environment. While other industries have benefited from approaches like Lean and Six Sigma, the pharmaceutical industry has been slow to adopt lean manufacturing.
The study aims to outline the scope for applying lean management principles in the pharmaceutical industry in order to improve quality and efficiency. It conducted surveys at 6 pharmaceutical companies in Hyderabad, India to understand their quality systems and potential for lean implementation. The surveys found awareness of lean was highest through websites and management guides, while business processes showed the lowest awareness. This indicates pharmaceutical firms should look for more opportunities to apply
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.
Total Quality Management (TQM) Practices toward Product Quality Performance: ...IOSRJBM
The purpose of this research was to test and analyze the effect of TQM practices impelementation which consists of leadership, strategic planning, customer focus, information and analysis, people management, and process management to product quality performance. The population were 108 food and beverage companies in Makassar, Indonesia. Respondents are production managers or operation managers. Sample technique which used is population sampling. Method of analysis which use both descriptive statistic and Structural Equation Modelling (SEM). Data processing uses two statistic tools i.e: IBM SPSS and AMOS 19.00. The findings of research indicate that leadership has significant effect on product quality performance, strategic planning has significant effect on product quality performance, customer focus has significant effect on product quality performance, information and analysis has significant effect on product quality performance, people management has significant effect on product quality performance, and process management has significant effect on product quality performance. Leadership factor has dominant effect on product quality performance (critical ratio = 9.760 > t-table = 1.960; and probability = 0.000 < α = 0.05).
Shamisha Learning Center, Ahmedabad, Gujarat, India-Specialized Training, Workshops and courses on Quality, Regulatory, R & D, Supply Chain and Manufacturing
This document discusses critical success factors for implementing total quality management. It analyzes 14 TQM frameworks and identifies common critical success factors across the frameworks. Through frequency analysis of the frameworks, it determines that the top critical success factors are: top management commitment, quality culture, strategic quality management, design quality management, process management, supplier quality management, education and training, empowerment and involvement, information and analysis, and customer satisfaction. The document establishes these 10 factors as critical for successful TQM implementation based on their prevalence across the frameworks analyzed.
Running Head MEDICAL NEEDS 1MEDICAL NEEDS 4.docxtodd581
Running Head: MEDICAL NEEDS 1
MEDICAL NEEDS 4
MEDICAL NEEDS
Institution Affiliation
Student Name
Date
There are eight important dimensional qualities that can serve a huge part in the development of a business. Some of these dimensions are equally reinforcing and push business to do better and move to the next level. However, product service or good can rank high in one of the dimensions and rank low in another dimension. For medical Needs business to give better results they should focus on building in these dimensions, (Chvala & Johnson, 2017).
Performance: Medical Needs should ensure that they provide all the medical devices that the doctors prescribe to any patient. They should plan in such a way that all products are available in the required time.
Features: Medical Needs should have products or services that supplement their core functioning. Medical Needs can provide a free weighing machine and free BMI testing.
Reliability: Medical Needs should work on providing products on the stipulated time and the right quantities, with this, they will receive the benefit of reliability which every customer is looking for.
Conformity: Just as Medical needs stated regarding a provision of vendors in all areas and ensuring that all medical products are available to the patients, they should focus mainly on that.
Durability: Medical Needs should focus mainly on providing durable products and services. They should try not to fail customers at any point, (Garvin, 1987).
Serviceability: This business should mainly focus on the needs of the customers. They should offer fast services, courteous services, competent work, and original medical products.
Aesthetics: The outlook of each product is so important, so it is very important for Medical Needs to ensure that their products have a better outlook and an attractive customer service.
Perception: Customer’s perception is crucial for any business. Medical Needs should listen to their customer’s plea and perception towards their services and work towards bettering the services according to the customer’s perception, (Ross, 2017).
To achieve quality gains, the managers need to perceive things in a different outlook. For any upcoming business, it will be necessary to perform these eight dimensions to ensure that their business picks up and moves to the next level. Medical Needs have a classified goal which is going to be achieved along implementation of the eight-dimensional model.
References
Chvala, R. J., & Johnson, W. C. (2017). Why Total Quality in Marketing. In Total Quality in Marketing (pp. 1-26). Routledge.
Garvin, D. (1987). Competing on the eight dimensions of quality. Harv. Bus. Rev., 101-109.
Ross, J. E. (2017). Total quality management: Text, cases, and readings. Routledge.
Medical Needs Quality Assurance Integration
Connie Farris
Colorado Technical University
Project Performance and Quality Assurance
(MPM357-1902A-02)
Jason Lewis
Running he.
Running Head MEDICAL NEEDS 1MEDICAL NEEDS 4.docxglendar3
Running Head: MEDICAL NEEDS 1
MEDICAL NEEDS 4
MEDICAL NEEDS
Institution Affiliation
Student Name
Date
There are eight important dimensional qualities that can serve a huge part in the development of a business. Some of these dimensions are equally reinforcing and push business to do better and move to the next level. However, product service or good can rank high in one of the dimensions and rank low in another dimension. For medical Needs business to give better results they should focus on building in these dimensions, (Chvala & Johnson, 2017).
Performance: Medical Needs should ensure that they provide all the medical devices that the doctors prescribe to any patient. They should plan in such a way that all products are available in the required time.
Features: Medical Needs should have products or services that supplement their core functioning. Medical Needs can provide a free weighing machine and free BMI testing.
Reliability: Medical Needs should work on providing products on the stipulated time and the right quantities, with this, they will receive the benefit of reliability which every customer is looking for.
Conformity: Just as Medical needs stated regarding a provision of vendors in all areas and ensuring that all medical products are available to the patients, they should focus mainly on that.
Durability: Medical Needs should focus mainly on providing durable products and services. They should try not to fail customers at any point, (Garvin, 1987).
Serviceability: This business should mainly focus on the needs of the customers. They should offer fast services, courteous services, competent work, and original medical products.
Aesthetics: The outlook of each product is so important, so it is very important for Medical Needs to ensure that their products have a better outlook and an attractive customer service.
Perception: Customer’s perception is crucial for any business. Medical Needs should listen to their customer’s plea and perception towards their services and work towards bettering the services according to the customer’s perception, (Ross, 2017).
To achieve quality gains, the managers need to perceive things in a different outlook. For any upcoming business, it will be necessary to perform these eight dimensions to ensure that their business picks up and moves to the next level. Medical Needs have a classified goal which is going to be achieved along implementation of the eight-dimensional model.
References
Chvala, R. J., & Johnson, W. C. (2017). Why Total Quality in Marketing. In Total Quality in Marketing (pp. 1-26). Routledge.
Garvin, D. (1987). Competing on the eight dimensions of quality. Harv. Bus. Rev., 101-109.
Ross, J. E. (2017). Total quality management: Text, cases, and readings. Routledge.
Medical Needs Quality Assurance Integration
Connie Farris
Colorado Technical University
Project Performance and Quality Assurance
(MPM357-1902A-02)
Jason Lewis
Running he.
Quality Management System including the Quality management and certificationAshwiniRaikar1
Concept of Quality, Total Quality Management, Quality by Design, Six Sigma concept, Out of Specification, Change control, Introduction to ISO 9000 Series of quality system standards, ISO 14000,NABL, GLP
Report: Recruitment in Pharmaceutical & Medical Devices in VietnamNavigos Group
Ho Chi Minh City, June 22, 2020 - Navigos Group, the leading provider of human resources services in Vietnam, publishes a report on “Pharmaceutical and Medical devices industry: distinctive features in recruitment and working environment” (in the report, will be referred to as Pharmaceutical industry). The report was conducted based on the analysis of the survey results of 601 candidates and 43 employers in the field of Pharmaceutical and Medical Devices in the database of Navigos Group.
This document discusses a study on the implementation of total quality management (TQM) principles in hospitals. The study used a cross-sectional survey design to collect data from nurses across four hospitals representing different health sectors. Factor analysis identified five key TQM principles being implemented: continuous improvement, teamwork, training, top management commitment, and customer focus. The study found that private hospitals have implemented TQM more than other sectors, while implementation was not related to nurse demographics except for the availability of a dedicated TQM unit.
Here are the key advantages and disadvantages of digital technology discussed in the passage:
Advantages:
- Improved image quality and resolution compared to analog films. Digital images can be enhanced, filtered and manipulated more easily.
- Images are available immediately after acquisition and can be stored, distributed and shared electronically. This improves workflow efficiency.
- Digital images reduce the need for repeat exposures as images can be adjusted on screen for brightness, contrast etc. to improve diagnostic quality.
- Lower costs compared to analog films due to reduced consumables, chemicals and processing. Digital archives also save space.
Disadvantages:
- Higher initial capital costs for purchasing digital imaging equipment like DR systems compared to analog equipment.
-
TQM is the integration of all functions and processes within an organization in order to achieve continuous improvement of the quality of goods and services. The goal is customer satisfaction.
Review Article: PROCESS ANALYTICAL TECHNOLOGY- Innovative pharmaceutical deve...Vignan University
Process Analytical Technology in pharmaceutical production checks the quality of the raw material attributes
both physically and chemically, that too off-line, in-line or on-line. Process analytical technologies have been
applied to manufacturing processes for decades. PAT is a system for design, analysis, and control of
manufacturing processes, 1
based on continuous monitoring/rapid measurements of critical quality and
performance attributes of raw material, intermediates and products. PAT involves measurement science by
using conventional process sensors such as pressure, temperature and probes. The PAT initiative was initially
intended for traditional pharmaceutical manufacturers, but the FDA.s, PAT guidance now clearly states that it
applies to all manufacturers of human and veterinary drug products. PAT involves shift from testing the quality
to building quality into products by testing at several intermediate steps. It specifically requires that
quantifiable, causal, and predictive relationships be established among the raw materials. There by decreasing
the chances of contamination and cross contamination. It also saves a huge amount of time and money required
for sampling and analysis of the products. Overall PAT paves a way for producing a quality product thus
satisfying the customer needs and creating a good brand image for the organization. PAT that will encourage
the voluntary development and implementation of innovative pharmaceutical development, manufacturing, and
quality assurance as well as novel analyzer technologies.
Research Inventy : International Journal of Engineering and Science is published by the group of young academic and industrial researchers with 12 Issues per year. It is an online as well as print version open access journal that provides rapid publication (monthly) of articles in all areas of the subject such as: civil, mechanical, chemical, electronic and computer engineering as well as production and information technology. The Journal welcomes the submission of manuscripts that meet the general criteria of significance and scientific excellence. Papers will be published by rapid process within 20 days after acceptance and peer review process takes only 7 days. All articles published in Research Inventy will be peer-reviewed.
To Analyze the Use of Statistical Tool/S for Cost Effectiveness and Quality o...iosrjce
Companies can lose money because they fail to use significant opportunities to improve product
quality as well as product cost. In order to survive in a competitive market, reduce cost of product by improving
the quality and productivity of product is must for any company.
The objective of this study is to provide system/instructions and methodology to reduce cost of product by
implementing statistical tools in local plastic injection molding company. Injection molding Company deployed
some part of the “Seven Basic Tools” to improve the quality of the product used by our society and reduce cost
of the product. Companies may reluctant to their quality status and customer satisfactory status without
implementing any helping tool which may reduce cost by identifying and decreasing number of defects and
consequently improving product quality and productivity of the system/process. Statistical techniques like
“Seven Basic Statistical Tools” (SPC) provides a very valuable and cost effective way to meet these objectives.
The principle aim of this study is to train quality personnel that how to use these SPC tools and exploit these
data in Pareto analysis, control Chart, Cause & Effect Diagram and histogram analysis. The causes of nonconformity
and root causes of quality problems were specified and possible remedies were proposed to
organization to overcome their problems. Some significant Improvement was also observed after SPC
implementation in Process potential capability (Cp), Process Actual Capability (Cpk) and Defective parts per
million (DPM)
A State-Of-Art Review Of Total Quality Management Application In Service Sectorinventionjournals
International Journal of Business and Management Invention (IJBMI) is an international journal intended for professionals and researchers in all fields of Business and Management. IJBMI publishes research articles and reviews within the whole field Business and Management, new teaching methods, assessment, validation and the impact of new technologies and it will continue to provide information on the latest trends and developments in this ever-expanding subject. The publications of papers are selected through double peer reviewed to ensure originality, relevance, and readability. The articles published in our journal can be accessed online.
Best Practices of Total Quality ManagementImplementation in .docxikirkton
Best Practices of Total Quality Management
Implementation in Health Care Settings
FAISAL TALIB
Mechanical Engineering Section, University Polytechnic, Faculty of Engineering and
Technology, Aligarh Muslim University, Aligarh, India
ZILLUR RAHMAN and MOHAMMED AZAM
Department of Management Studies, Indian Institute of Technology Roorkee,
Roorkee, India
Due to the growing prominence of total quality management
(TQM) in health care, the present study was conducted to identify
the set of TQM practices for its successful implementation in
healthcare institutions through a systematic review of literature.
A research strategy was performed on the selected papers published
between 1995 and 2009. An appropriate database was chosen and
15 peer-reviewed research papers were identified through a
screening process and were finally reviewed for this study. Eight
supporting TQM practices, such as top-management commitment,
teamwork and participation, process management, customer focus
and satisfaction, resource management, organization behavior
and culture, continuous improvement, and training and educa-
tion were identified as best practices for TQM implementation in
any health care setting. The article concludes with a set of recom-
mendations for the future researchers to discuss, develop, and work
upon in order to achieve better precision and generalizations.
KEYWORDS health care institutions, total quality management,
TQM implementation, TQM practices
Address correspondence to Faisal Talib, Assistant Professor, Mechanical Engineering
Section, University Polytechnic, Faculty of Engineering and Technology, Aligarh Muslim
University, Aligarh-202002, Uttar Pradesh, India. E-mail: [email protected]
Health Marketing Quarterly, 28:232–252, 2011
Copyright # Taylor & Francis Group, LLC
ISSN: 0735-9683 print=1545-0864 online
DOI: 10.1080/07359683.2011.595643
232
INTRODUCTION
The health care and medical services are growing immensely due to a high
influx of the private sector, changing disease patterns, medical tourism,
and demographic variations. Development of new and advanced techniques,
increased awareness on patient’s safety, intensity of competition in health
care market, and new generation of purchasers and providers have forced
the health care institutions to improve the efficiency and introduce a
consumer culture in their institutions for effective cost and quality of care
(Mosadegh Rad, 2005; Lee, Ng, & Zhang, 2002; Short, 1995). Quality of care
is the vital issue for every health care institution and there is an immediate
need for health care reforms in order to address and resolve the problems
associated with quality of care, as well as patient preferences, safety, and
choice (Koeck, 1997). Another critical issue is the consistently increasing
operating costs of health care institutions. Rising health care expenditures
have created serious financial burdens for the ex-chequer (government
department in charge of national revenue or national ...
This study aims to classify the business models of pharmaceutical firms in Thailand. Through qualitative analysis of 12 in-depth interviews, the study identified 7 key themes (market, customer, product, price, strategy, cost management, performance) to classify business models as public health, innovative, or mixed. A public health model focuses on accessible pricing and standard products for public markets. An innovative model focuses on premium pricing and first-in-class products for private/self-pay markets. Many firms use a mixed model balancing public health and innovative approaches. The classification provides guidance for pharmaceutical management in determining suitable business models.
This document discusses concepts related to quality assurance and total quality management in the pharmaceutical industry. It provides definitions of quality assurance, outlines the responsibilities of manufacturers to ensure product quality, and explains that quality assurance involves controlling sources of variation and ensuring compliance with standards through testing. A total quality management approach aims to prevent defects through continuous improvement rather than just detecting defects. The document also summarizes various quality management techniques including statistical process control tools, Deming's plan-do-check-act cycle, and the contributions of quality gurus like Deming, Juran, Ishikawa and Taguchi.
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2228 | P a g e
directly with people’s lives and health. And the tiniest
error in production or environmental cleaning methods will
cause direct or indirect irretrievable damages to the social
or personal health. Hence, although there are several
standards issued by different organizations in this field, we
have decided to use the Total Quality Management as a
critical approach to this industry so that we would be able
to take a small step towards better quality and health
throughout the society.
Related works
Many researchers have been conducted concerning the
TQM and its effects on the performance of organizations.
By performance, we mean their financial performance,
quality of their products, the satisfaction of both employees
and customers, performance of the market, results and the
reduction of costs.
In an international quality search (IQS), conducted by
Ernst and Young, it is concluded that quality is considered
as an important factor in large American, German,
Japanese and Canadian corporations. There have also been
some studies about the relationship between the quality
and trade benefits of the organizations (Sohal & Eddy).
Kim (1997) researched on the strategies concerned with
quality and development plans in western manufacturing
companies and concluded that most successful companies
had used step by step method and had achieved the
competitive advantage through it. These steps include;
holding sessions (conferences), reliability, functionality
and custom-manufacturing.
In 2004 and 2005, several studies were conducted on the
relationship between the Total Quality Management and its
effects on the performance of organizations. It was
concluded that there was a positive relationship between
applying the quality management and the organizational
performance (Lassaad lakhal).
Calvin London conducted a research about the application
of quality policies in the pharmaceutical companies in
2005. He defined the limits of the study and discovered
that both middle and top management had significant roles
in the success of the organizational quality policies.
One of these studies was a research about the effects of the
Total Quality Management on the performance of Indian
pharmaceutical industry, as the result of which a series of
effective factors on the TQM were identified (Dr. R. S.
Dhalla, 2010).
Brown (2011) has provides an attitude towards the TQM as
a useful tool in integration, which clarifies the relationship
between main departments of an organization, namely
financial department, designing, marketing, production,
purchase, engineering and the human recourses in order to
result in both customer satisfaction and organizational
goals.
Many studies have been done on the TQM, all of which
insist on the critical factors of success, equipment and
different methodologies in order to execute a successful
application.
On the other hand, various methods are available for
decision-making such as Data Envelopment Analysis
(DEA), Analytic Hierarchy Process (AHP) and fuzzy
methods, etc.
Saati (1994 – 1996) used AHP,considered as one of the
most frequently used methods in decision-making with
multiple factors, to deal with complicated functional
problems. This method uses both quantitative and
qualitative data for analysis (Rowan, 2007). It is possible
to posit a balance and prioritization considering the main
factors and sub-factors in order to reach an effective
decision (Chin 2002).
Saati defines two types of fuzziness; one is in
understanding the phenomena and the other one exists in
meaning, which is related to the performance of the
phenomena. To calculate the phase AHP along with
several DM, two other researchers (Laerhon and Pedirsiz)
used the least squared logarithms for measuring the values,
and found the relations using the fuzzy triangle method.
The other method is known as buckley Method which is
famous as the fuzzy trapezium method.
One of the most common methodologies in multi-factor
decision-making is the Analytic Network Process (ANP),
which is in fact an improvement to the AHP. Actually it
was Saati who suggested ANP in order to extend his theory
about the AHP, in which there are interactions,
dependencies, both inside (inside a group) and outside
(between indicators of different kinds), among the
elements and clusters. There are also dependencies
between options and parameters as well. This will help us
choose the real-like optimal option.
This study attempts to use the combination of different
experts’ ideas in identifying important factors and use
fuzzy ANP to prioritize the effective factors on the TQM
(related to the Iranian pharmaceutical industry).
Research Main Goals
Major goal
Determining the existing priority among the TQM
influential indicators in the pharmaceutical industry in
order to reach a higher quality, and as the result, the health
of the patients and society
Minor goals
Determining the paired comparison matrix among the
Key Performance Indicators
Determining the paired comparison matrix between
the Key Performance Indicators and influential
indicators on the Total Quality Management
Determining the super-matrix
Determining the existing priorities among the TQM
indicators in the Iranian pharmaceutical industry
Research questions
What are the Key Performance Indicators in the
Iranian pharmaceutical industry?
What is the existing priority among the influential
indicators on the TQM, considering the key
indicators?
The Result
This study was conducted in order to improve the quality.
Its results would make the pharmaceutical manufacturers,
3. International Journal of Current Life Sciences - Vol.4, Issue, 6, pp.2227-2231, June, 2014
2229 | P a g e
especially the top managers, concentrate more on the key
points in their production so that, considering the
prioritization resulting from this study, they can overcome
the problems on the way of optimal production to reach a
higher organizational quality and social health.
METHODOLOGY
This study deals with two types of data; one type is the
initial data which is the Key Performance Indicator (KPI)
and the other one is the secondary data which includes the
influential indicators on the TQM and which was related to
the national pharmaceutical industry. In order to
distinguish these data, we have combined the experts’
ideas in this field and the previous studies.
1. The main data (Key Performance Indicators) include
customer satisfaction, employee satisfaction and the
effects on society
2. The secondary data (the influential indicators on the
TQM) consist of the top managers, employees,
customers, suppliers, distributors, education and the
team work.
The graph 1 represents the indicators and their
relationships.
The figure 1 identifies the indicators and the type of
relationships among them in the Super Decisions software.
Data Collection
The following methods and tools were used for gathering
data for this study;
The library and the Internet, including books, papers
and case studies, were used to provide theoretical
background.
The experts’ ideas were used in determining the Key
Performance Indicators (initial data).
The experts’ ideas and 13 GMP principles were
combined in order to determine the secondary data,
including the influential indicators on the TQM and
the indicators related to the national pharmaceutical
industry.
Sampling Population
The sampling population, in order to determine the
appropriate indicators and the values related to the initial
data, includes the middle managers of the pharmaceutical
companies of the country.
Sampling Method
We have applied the non-accidental access method in
which we have used the list of the pharmaceutical
companies in Tehran. We selected some of them and
distributed the questionnaires among their middle
managers
Paired comparisons and problem solution using the
Super Decisions software
The paired comparisons are conducted considering the
following 9 spectra;
The paired comparison tables were defined as the
following, after being completed by the experts and having
the date entered into the software;
Comparison
status
Equal
importance
Almost more
important
More
important
Much more
important
Extremely
important
Preferred value 1 3 5 7 9
Table 1 paired comparison for the key performance
indicators
Key
Performance
Indicators
Customer
satisfaction
Employee
satisfaction
Effects
on
society
Customer
satisfaction
1.000000 7.000000 8.000000
Employee
satisfaction
1.142860 1.000000 4.000000
Effects on
society
0.125000 0.250000 1.000000
Table 2 paired comparison for the influential indicators on the TQM considering the customer satisfaction
Customer
satisfaction
Customers Distributors Employees Suppliers
Team
work
Top managers Education
Customers 1.00000 8.00000 7.00000 8.00000 6.00000 4.00000 4.00000
Distributors 0.12500 1.00000 2.00000 1.00000 1.00000 0.12500 3.00000
Employees 0.14286 0.50000 1.00000 4.00000 1.00000 0.25000 4.00000
Suppliers 0.12500 1.00000 0.25000 1.00000 0.25000 0.12500 0.25000
Team work 0.16667 1.00000 1.00000 4.00000 1.00000 0.12500 1.00000
Top managers 0.25000 8.00000 4.00000 8.00000 8.00000 1.00000 7.00000
Education 0.25000 0.33333 0.25000 4.00000 1.00000 0.14286 1.00000
4. International Journal of Current Life Sciences - Vol.4, Issue, 6, pp.2227-2231, June, 2014
2230 | P a g e
As an example, the method of entering the date related to
the paired comparison is presented in the figure 2, which
can be done in three ways of graphics, matrix and verbal,
as it can be seen.
Table 3 paired comparison for the influential indicators on the TQM considering the employee satisfaction
Employee
satisfaction
Customers Distributors Employees Suppliers
Team
work
Top managers Education
Customers 1.00000 4.00000 0.25000 4.00000 1.00000 0.25000 0.25000
Distributors 0.25000 1.00000 0.14290 1.00000 0.25000 0.20000 0.25000
Employees 4.00000 6.99790 1.00000 7.00000 1.00000 0.14286 1.00000
Suppliers 0.25000 1.00000 0.14286 1.00000 0.25000 0.25000 0.12500
Team work 1.00000 4.00000 1.00000 4.00000 1.00000 0.25000 1.00000
Top managers 4.00000 5.00000 7.00010 4.00000 4.00000 1.00000 1.00000
Education 0.40000 4.00000 1.00000 8.00000 1.00000 1.00000 1.00000
Table 4 paired comparison for the influential indicators considering the effects on society
effects on society Customers Distributors Employees Suppliers Team work
Top
mana
gers
Education
Customers 1.00000 3.00000 0.25000 3.00000 0.25000 0.11111 0.25000
Distributors 0.33333 1.00000 0.16667 1.00000 0.25000 0.12500 0.14286
Employees 4.00000 5.99999 1.00000 7.00000 1.00000 0.14286 1.00000
Suppliers 0.33333 1.00000 0.14286 1.00000 0.25000 0.12500 0.14286
Team work 4.00000 4.00000 1.00000 4.00000 1.00000 1.00000 1.00000
Top managers 9.00001 8.00000 7.00001 8.00000 1.00000 1.00000 1.00000
Education 4.00000 7.00001 1.00000 7.00001 1.00000 1.00000 1.00000
Table 12 the following figure is a part of the super-
matrix calculated by the software
Table 5 paired comparison for the Key Performance
Indicators considering the customers
Customers
Customer
satisfaction
Employee
satisfaction
effects on
society
Customer
satisfaction
1.00000 7.00000 6.00000
Employee
satisfacti
on
0.14286 1.00000 1.00000
effects on the
society
0.16667 1.00000 1.00000
Table 6 paired comparison for the Key Performance
Indicators considering the distributors
Distributors
Customer
satisfaction
Employee
satisfaction
effects on
society
Customer
satisfaction
1.00000 4.00000 5.00000
Employee
satisfaction
0.25000 1.00000 5.00000
ffects on society 0.20000 0.20000 1.00000
Table 7 paired comparison for the Key Performance
Indicators considering the employees
Employees
Customer
satisfaction
Employee
satisfaction
effects on
society
Customer
satisfaction
1.00000 0.20000 4.00000
Employee
satisfaction
5.00000 1.00000 6.00000
effects on
society
0.25000 0.16667 1.00000
Table 8 paired comparison for the Key Performance
Indicators considering the suppliers
Suppliers
Customer
satisfaction
Employee
satisfaction
effects on
society
Customer
satisfaction
1.00000 0.33330 1.00000
Employee
satisfaction
3.00030 1.00000 4.00000
effects on
society
1.00000 0.25000 1.00000
Table 9 paired comparison for the Key Performance
Indicators considering the team work
Team work
Customer
satisfaction
Employee
satisfaction
effects on
society
Customer
satisfaction
1.00000 0.16670 1.00000
Employee
satisfaction
5.99880 1.00000 7.00000
effects on
society
1.00000 0.14286 1.00000
Table 10 paired comparison for the Key Performance
Indicators considering the top managers[
Top managers
Customer
satisfaction
Employee
satisfaction
effects on
society
Customer
satisfaction
1.00000 3.00000 5.00000
Employee
satisfaction
0.33333 1.00000 6.00000
effects on
society
0.20000 0.25000 1.00000
Table 11 paired comparison for the Key Performance
Indicators considering the education
Education
Customer
satisfaction
Employee
satisfaction
effects on
society
Customer
satisfaction
1.00000 0.25000 1.00000
Employee
satisfaction
4.00000 1.00000 6.00000
effects on
society
1.00000 0.16667 1.00000
5. International Journal of Current Life Sciences - Vol.4, Issue, 6, pp.2227-2231, June, 2014
2231 | P a g e
CONCLUSION
After the paired comparisons and super-matrix calculations
by the software, the existing priority among the indicators
was determined as presented in the following table
The important point to get from the above-mentioned
priorities is the fact that the organizational top managers
have the highest sensitivity, which is similar to conclusions
of the previous studies. As the result, paying more
attention to them will help us achieve the higher quality
and consequently the customer satisfaction.
Considering the resulted priorities and comparing it to the
previous studies, it can be seen that the customers are
highly important in the pharmaceutical industry, which
shows the sensitivity of the practices in that industry since
it deals with people’s health.
The other important point to pay attention to is the higher
importance which the medicine distributors give to the
suppliers who must have a better management concerning
the medicine distribution and supervision.
Sources
1. Arawati Agus .Za faran hasan (2011).Enhancing
production performance and customer performance
through total quality management (TQM).Social and
behavioral sciences 24,1650-1662
2. Asgharpour, Mohammad Javad (1390 A.H.).
Multifunctional Decision Making. Tehran; Tehran
University Publications
3. Bhaskar Mazumder (Jun- Mar 2011). Total Quality
Management in Pharmaceuticals: A Review
International Journal of Pharm Tech Research.
4. Cebeci.u.. and Runan.D.(2007). A multi-attribute
comparison of Turkish quality consults by fuzzyAHP.
International journal of information technology
&decision making.6(1).p.191-207
5. Dr.R.S.Dhalla (January 9-10.2010). Effect of Total
quality management on performance of India
Pharmaceutical Industries. International Conference
on Industrial Engineering and operations
Management Dhaka. Bangladesh.
6. Fattahi, Parviz (1388 A.H.). Quality Management and
Utilization. Tehran; Payam-e Noor University
Publications
7. Momeni Mansour (1388 A.H.). Multi-indicator
Decision-making models and software. Tehran;
SAMT Publications
Figure 2 the method for entering the date related to the paired
comparison in the software
Table 13 the final report provided by the software
Indicators Total normal ideal Ranking
Customers 0.1109 0.1789 0.6948 3
Distributors 0.0187 0.0303 0.1175 6
Employees 0.1397 0.2254 0.8755 2
Suppliers 0.0116 0.0187 0.0756 7
Team work 0.1093 0.1763 0.6847 4
Top managers 0.1596 0.2575 1.0000 1
Education 0.0699 0.1129 0.4383 5
********