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.
Enterprise Labeling for the Medical Device IndustryLoftware
IT’S TIME FOR POWERFUL NEW SOLUTIONS IN MEDICAL
DEVICE LABELING. For medical device manufacturers, labeling is growing in importance, and there are a number of reasons why.
A brief introduction of the outsourcing methods in Pharma Supply Chain, Types of Outsourcing, Framework to decide correct outsourcing partner, factors to consider while selecting a partner, Process of outsourcing and Outsourcing models.
FDA has made several efforts to secure the pharmaceutical supply chain:
1. The Office of Compliance within CDER was reorganized to better address threats like counterfeiting, diversion, and intentional adulteration. A new Office of Drug Security, Integrity, and Recalls was created.
2. Preliminary analysis of FDA criminal case information from 2003-2008 found that the top five branded drugs targeted were Zyprexa, Viagra, Lipitor, Zoloft, and Risperdal, and that solid oral dosage forms were most at risk.
3. FDA is working on track and trace standards and held a public workshop on the topic in 2011. A track and trace system
The pharmaceutical supply chain is complex and highly regulated. It involves multiple players from drug discovery and development to manufacturing and distribution. Ensuring patient safety is the top priority and challenge, as the supply chain is vulnerable to counterfeiting and issues regarding product quality. Emerging technologies around tracking and authentication aim to address these problems. Regulation and compliance add further complexity, as the industry works to balance costs and efficiencies with ethical and safety requirements.
Impax reported its fourth quarter and full year 2016 financial results. Revenue declined year-over-year due to continued pricing pressures and volatility in the generic drug market. The company reported a net loss for the year due to non-cash impairment charges related to intangible assets. Looking ahead, Impax expects the challenging market conditions to continue but believes its specialty drug portfolio and generic pipeline can drive growth. Key priorities for 2017 include reducing debt, improving efficiency, and investing in R&D and generic launches.
The document discusses establishing a supply chain department in a pharmaceutical industry. It outlines objectives to improve planning capabilities, reconfigure the supply chain footprint, make product design and packaging more flexible, adopt tailored business streams, and create a network of third-party suppliers. It also discusses the company's vision, mission, products/services, target markets, participants, manufacturing locations, SWOT analysis, seasonal aspects, forecasting techniques and objectives, production strategy, master production scheduling, bill of materials, and challenges with production and material planning.
This document provides an overview of the pharmaceutical formulation landscape as of April 2005. It discusses key aspects of pharmaceutics including the diverse scientific disciplines involved. It outlines market segments and trends driving increased outsourcing and emphasis on formulation. These include industry downsizing, emergence of biologics, and need for specialized expertise. The document also provides estimates for the size of the US formulation and manufacturing services market and maps some of the major competitors.
The document summarizes the current state and challenges facing India's pharmaceutical supply chain. It finds that while the industry has grown significantly, Indian pharma companies are still lagging best practices in key performance areas like customer service, inventory levels, and supply chain costs. Major challenges include issues with quality and regulatory compliance that are affecting exports and domestic sales, as well as high product proliferation, supply chain fragmentation, and some infrastructure gaps. Addressing these challenges will be important for the industry to sustain growth and gain a competitive advantage.
Enterprise Labeling for the Medical Device IndustryLoftware
IT’S TIME FOR POWERFUL NEW SOLUTIONS IN MEDICAL
DEVICE LABELING. For medical device manufacturers, labeling is growing in importance, and there are a number of reasons why.
A brief introduction of the outsourcing methods in Pharma Supply Chain, Types of Outsourcing, Framework to decide correct outsourcing partner, factors to consider while selecting a partner, Process of outsourcing and Outsourcing models.
FDA has made several efforts to secure the pharmaceutical supply chain:
1. The Office of Compliance within CDER was reorganized to better address threats like counterfeiting, diversion, and intentional adulteration. A new Office of Drug Security, Integrity, and Recalls was created.
2. Preliminary analysis of FDA criminal case information from 2003-2008 found that the top five branded drugs targeted were Zyprexa, Viagra, Lipitor, Zoloft, and Risperdal, and that solid oral dosage forms were most at risk.
3. FDA is working on track and trace standards and held a public workshop on the topic in 2011. A track and trace system
The pharmaceutical supply chain is complex and highly regulated. It involves multiple players from drug discovery and development to manufacturing and distribution. Ensuring patient safety is the top priority and challenge, as the supply chain is vulnerable to counterfeiting and issues regarding product quality. Emerging technologies around tracking and authentication aim to address these problems. Regulation and compliance add further complexity, as the industry works to balance costs and efficiencies with ethical and safety requirements.
Impax reported its fourth quarter and full year 2016 financial results. Revenue declined year-over-year due to continued pricing pressures and volatility in the generic drug market. The company reported a net loss for the year due to non-cash impairment charges related to intangible assets. Looking ahead, Impax expects the challenging market conditions to continue but believes its specialty drug portfolio and generic pipeline can drive growth. Key priorities for 2017 include reducing debt, improving efficiency, and investing in R&D and generic launches.
The document discusses establishing a supply chain department in a pharmaceutical industry. It outlines objectives to improve planning capabilities, reconfigure the supply chain footprint, make product design and packaging more flexible, adopt tailored business streams, and create a network of third-party suppliers. It also discusses the company's vision, mission, products/services, target markets, participants, manufacturing locations, SWOT analysis, seasonal aspects, forecasting techniques and objectives, production strategy, master production scheduling, bill of materials, and challenges with production and material planning.
This document provides an overview of the pharmaceutical formulation landscape as of April 2005. It discusses key aspects of pharmaceutics including the diverse scientific disciplines involved. It outlines market segments and trends driving increased outsourcing and emphasis on formulation. These include industry downsizing, emergence of biologics, and need for specialized expertise. The document also provides estimates for the size of the US formulation and manufacturing services market and maps some of the major competitors.
The document summarizes the current state and challenges facing India's pharmaceutical supply chain. It finds that while the industry has grown significantly, Indian pharma companies are still lagging best practices in key performance areas like customer service, inventory levels, and supply chain costs. Major challenges include issues with quality and regulatory compliance that are affecting exports and domestic sales, as well as high product proliferation, supply chain fragmentation, and some infrastructure gaps. Addressing these challenges will be important for the industry to sustain growth and gain a competitive advantage.
Risk management in pharmaceutical supply chainMohammad Fat'hy
In the modern day, a company's competitive advantage in most industries will be determined by maximizing its relationships and the diligent management of its forward and backwards facing supply chains.
The ability to effectively manage risks in a supply chain is an absolute must in the skill set of any current supply chain professional. This course will equip and develop procurement and supply chain professionals to be able to operate diligently and effectively with their supply base, mitigating any risks and maximizing all opportunities to gain competitive advantage in their market place.
Cowen and Company 37th Annual Health Care Conference Presentationimpax-labs
Impax provides a forward-looking statement regarding risks and uncertainties for its business. It discusses various risks including fluctuations in revenues and operating income, reliance on key customers and products, supply chain risks, competition, product development risks, and regulatory risks. Impax also outlines steps it has taken to reduce costs and optimize operations, with estimated annual savings of $40-50 million by 2018. Its priorities for 2017 include focusing on quality, executing specialty product growth, maximizing generics profits, and exploring more efficiencies.
Impax Labs - 35th Annual JP Morgan Healthcare Conferenceimpax-labs
1) Impax provides a forward-looking statement regarding risks and uncertainties that could impact future performance.
2) Impax operates both a generic pharmaceutical division and specialty pharmaceutical division focused on central nervous system disorders.
3) Impax is focusing on growth opportunities including product development and approvals, marketing execution, and business development activities while also improving operations and reducing debt.
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.
Transforming Pharmaceutical Operational Performance with Supply Chain Traceab...SupplyScape
This document discusses how track and trace technologies can transform pharmaceutical business performance by enabling supply chain as a strategic asset. It provides an overview of trends driving increased focus on supply chains, describes implications of track and trace on supply chain operations and security. The document also presents two case studies, one on a global pharmaceutical manufacturer and one on a leading drug store chain, analyzing potential benefits of track and trace technologies across various operational areas like inventory management, out-of-stock reduction, returns management, and more. It concludes by suggesting pharmaceutical companies need to address compliance responsibilities globally and prioritize an implementation plan to leverage investments in track and trace.
Chinas Changing Role in the Global Pharmaceutical Supply ChainRobert W. Kennedy
The document discusses China's growing role in the global pharmaceutical supply chain. It notes that China now has over 150 established API manufacturers, up from around 100 in 2005. Regulatory filings by Chinese companies to markets like the US and Europe have also increased significantly in recent years. However, challenges remain around compliance, quality assurance, and technology theft. The document compares China's API manufacturing landscape to countries like India and Italy, finding that while China lags in experience it is making progress. It also explores China's moves towards finished dosage form production and US ANDA approvals.
Supply Chain Management of Pharmaceuticals CompanyRageeb Hasan
This document analyzes the supply chain management of Eskayef Pharmaceuticals Ltd., a leading pharmaceutical company in Bangladesh. It begins with an executive summary that outlines the objectives of studying Eskayef's supply chain and how it is managed. The document then provides background on Eskayef and states the research questions. It describes the methodology used, which included surveys of Eskayef employees, retailers, and customers. The findings suggest that Eskayef faces challenges like lack of coordination and inventory management issues. However, respondents also reported benefits of Eskayef's supply chain like reduced costs and cycle times. In closing, the document notes the importance of effective supply chain management in the pharmaceutical industry.
The New Pharma Ecosystem: 2014 Trends Reshaping the Pharmaceutical Supply ChainLaura Olson
The pharmaceutical industry is undergoing tremendous changes. Numerous forces are re-shaping the new pharmaceutical ecosystem. Technology, demographics, regulations and shifts in wealth are creating transformative change. Increasingly becoming a more patient-centric world, patients use Smart devices to monitor research and evaluate pharmaceutical products. Healthcare reform regulations, the devaluation of the existing pharma model and trend towards patient empowerment and access to information are shaping the changing pharma industry, much as the retail industry was shaped by the multichannel and omni channel retailing trends of recent years. Regulators have become increasingly more cautious when improving innovative medicines. As pharmaceuticals have become more successful in prolonging life and treating illness, many medical conditions are now chronic. Today healthcare providers have become increasingly interested in measuring the outcomes of pharma performance and basing pricing accordingly. There has been a dramatic increase in prescription volume and an increased production and use of generic drugs. Producing pharmaceuticals in other countries can be complicated. Customs, local regulations and other factors impact products and require brands to adapt. Generic pharmaceuticals are becoming the dominant category globally, especially in developing rather than just industrial countries. Adding to the complexity, a large number of pharmaceutical products are made by multiple countries. These factors and the move towards specialty pharmaceuticals and greater production of pharmaceutical products globally have resulted in more pressure on global supply chains. Because supply chains have moved from local to global in operation, even one significant event can interrupt the global supply chain. Events such as hurricanes and typhoons, earthquakes, political and economic upheaval can have serious impacts on global supply chains, adding unforeseen costs and delays. Health care reform magnifies the effect of longer supply chains and increases the intense cost pressure on drug manufacturers. In order to reduce costs, more production as well as research and development are being offshored and outsourced.
Waste in hospitals - everywhere - is massive. Up to 50% of consumables and devices purchased are never used on a patient. Support activities are highly manual, repetitive and done by professional clinical staff...
This presentation sets out the strategic environment and discusses the development and successful implementation of a leading-edge process and supply chain solution for hospitals.
Pfizer is the world's largest pharmaceutical company by revenue. It has over 103,700 employees worldwide and had $67.42 billion in revenue in 2011. In India, Pfizer has over 3,000 employees and a manufacturing facility in Thane, Maharashtra. The pharmaceutical industry is forecast to have 5-8% annual growth to 2015 despite economic challenges. Companies are focusing on supply chain management and cost cutting to drive efficiency. Effective management of transportation, inventory, expiration dates and recalls is important for pharmaceutical supply chains.
This document discusses issues with CAPA (Corrective and Preventive Action) programs and best practices for improvement. It notes that CAPA continues to be a top citation for pharmaceutical companies. It recommends taking a holistic approach to CAPA, with planning, source error tracking across the product lifecycle into a sole database, trend analysis integrated with risk management, and employee training and accountability. With these improvements, companies can better identify and address quality issues.
Corporate Research Project on Pharmaceutical Industry of SingaporeSanket Golechha
This document outlines a capstone research project on logistics and supply chains in the pharmaceutical industry. The project aims to study supply chain regulations and security in Singapore to eliminate counterfeit drugs. The research framework includes examining the pharmaceutical business environment, logistics environment, supply chain complexity, regulations, and counterfeiting risks. Primary research will involve interviews with industry and academic experts. Secondary research methods include reviewing literature, reports, and case studies. Key findings and recommendations will aim to suggest improvements to supply chain security for the pharmaceutical industry in Singapore.
Medical device companies struggle with CAPA compliance due to fragmented and manual systems. An effective CAPA system requires planning, integrated data sources, risk-based prioritization of issues, and trend analysis. It also needs employee training and management processes to monitor performance and drive accountability. A comprehensive electronic CAPA management system can help companies achieve compliance by connecting people, procedures, and data across the organization.
Developing And Executing A Program For Labeling ComplianceChris Miller
The document discusses developing a program for labeling compliance. It notes that labeling has become complex due to increasing regulations from various government bodies. An ideal solution would be one that adapts to regulatory changes and lowers risks of non-compliance. Key aspects of implementing a solution include user training, validation, label design, documentation, and supplier management. The document provides an overview of developing a holistic labeling compliance program.
Pfizer is the world's largest pharmaceutical company with revenues of $49.6 billion in 2014. It has over 78,000 employees worldwide and key products include Lipitor, Lyrica, Viagra, and Celebrex. In India, Pfizer has over 3,000 employees and a manufacturing facility in Thane, Maharashtra. Pfizer utilizes a complex global supply chain network involving over 300 suppliers to procure and deliver materials and finished products to customers in over 175 distribution centers worldwide while managing risks such as cargo theft and counterfeiting.
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.
Impax Announces Agreement to Acquire Generic Products - June 21, 2016impax-labs
Impax announces it has agreed to acquire a portfolio of 18 generic products from an undisclosed party for $586 million in cash. The acquisition expands Impax's portfolio of solid oral, injectable, inhalable, and topical generic drugs. It is expected to add $80 million in revenue and $50 million in EBITDA in the second half of 2016 and be immediately accretive to earnings per share. Impax provides updated 2016 financial guidance incorporating the acquisition, projecting at least 15% revenue growth over 2015 to over $860 million.
Impax provides concise summaries of forward-looking statements and highlights its focus on four key areas:
1) Continued focus on quality to resolve regulatory issues and gain approvals of generic products.
2) Maximization of its generic and specialty pharmaceutical platforms through pipeline of potential launches representing billions in sales.
3) Optimization of its generic research and development pipeline including first-to-file opportunities representing $19 billion in potential sales.
4) Pursuit of business development to accelerate growth including advancement of its next-generation brand pipeline programs.
The document discusses the supply chain of the pharmaceutical industry. It describes the typical supply chain process including raw material sourcing, manufacturing, distribution and dispensing. It highlights several critical issues in managing pharmaceutical supply chains including maintaining temperature control, complex network design, and focus on research and development. It also discusses risks in pharmaceutical supply chains such as uncertainty in demand and the product development pipeline. Finally, it provides an overview of the current distribution system in India which involves clearing and forwarding agents and stockists.
Paper chromatography is a technique used to separate mixtures into individual components. It works by allowing the molecules in a mixture to distribute themselves between a stationary phase (filter paper) and a mobile phase (solvent). Different molecules will travel different distances up the paper depending on how strongly they interact with each phase. Paper chromatography has been replaced in many applications by thin layer chromatography, which provides faster runs and better separation. However, paper chromatography is still useful for teaching chromatography principles in educational settings.
Paper chromatography (PC) was introduced in 1865 and is considered the simplest chromatographic technique. It involves using filter paper as the stationary phase and a solvent as the mobile phase. There are two types of PC - adsorption chromatography where the paper is coated with an adsorbent like silica or alumina, and partition chromatography where moisture in the paper acts as the stationary phase. Compounds are separated based on their partitioning between the stationary and mobile phases. PC is useful for separating mixtures and identifying compounds due to its low cost, simplicity, and good resolving power.
Risk management in pharmaceutical supply chainMohammad Fat'hy
In the modern day, a company's competitive advantage in most industries will be determined by maximizing its relationships and the diligent management of its forward and backwards facing supply chains.
The ability to effectively manage risks in a supply chain is an absolute must in the skill set of any current supply chain professional. This course will equip and develop procurement and supply chain professionals to be able to operate diligently and effectively with their supply base, mitigating any risks and maximizing all opportunities to gain competitive advantage in their market place.
Cowen and Company 37th Annual Health Care Conference Presentationimpax-labs
Impax provides a forward-looking statement regarding risks and uncertainties for its business. It discusses various risks including fluctuations in revenues and operating income, reliance on key customers and products, supply chain risks, competition, product development risks, and regulatory risks. Impax also outlines steps it has taken to reduce costs and optimize operations, with estimated annual savings of $40-50 million by 2018. Its priorities for 2017 include focusing on quality, executing specialty product growth, maximizing generics profits, and exploring more efficiencies.
Impax Labs - 35th Annual JP Morgan Healthcare Conferenceimpax-labs
1) Impax provides a forward-looking statement regarding risks and uncertainties that could impact future performance.
2) Impax operates both a generic pharmaceutical division and specialty pharmaceutical division focused on central nervous system disorders.
3) Impax is focusing on growth opportunities including product development and approvals, marketing execution, and business development activities while also improving operations and reducing debt.
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.
Transforming Pharmaceutical Operational Performance with Supply Chain Traceab...SupplyScape
This document discusses how track and trace technologies can transform pharmaceutical business performance by enabling supply chain as a strategic asset. It provides an overview of trends driving increased focus on supply chains, describes implications of track and trace on supply chain operations and security. The document also presents two case studies, one on a global pharmaceutical manufacturer and one on a leading drug store chain, analyzing potential benefits of track and trace technologies across various operational areas like inventory management, out-of-stock reduction, returns management, and more. It concludes by suggesting pharmaceutical companies need to address compliance responsibilities globally and prioritize an implementation plan to leverage investments in track and trace.
Chinas Changing Role in the Global Pharmaceutical Supply ChainRobert W. Kennedy
The document discusses China's growing role in the global pharmaceutical supply chain. It notes that China now has over 150 established API manufacturers, up from around 100 in 2005. Regulatory filings by Chinese companies to markets like the US and Europe have also increased significantly in recent years. However, challenges remain around compliance, quality assurance, and technology theft. The document compares China's API manufacturing landscape to countries like India and Italy, finding that while China lags in experience it is making progress. It also explores China's moves towards finished dosage form production and US ANDA approvals.
Supply Chain Management of Pharmaceuticals CompanyRageeb Hasan
This document analyzes the supply chain management of Eskayef Pharmaceuticals Ltd., a leading pharmaceutical company in Bangladesh. It begins with an executive summary that outlines the objectives of studying Eskayef's supply chain and how it is managed. The document then provides background on Eskayef and states the research questions. It describes the methodology used, which included surveys of Eskayef employees, retailers, and customers. The findings suggest that Eskayef faces challenges like lack of coordination and inventory management issues. However, respondents also reported benefits of Eskayef's supply chain like reduced costs and cycle times. In closing, the document notes the importance of effective supply chain management in the pharmaceutical industry.
The New Pharma Ecosystem: 2014 Trends Reshaping the Pharmaceutical Supply ChainLaura Olson
The pharmaceutical industry is undergoing tremendous changes. Numerous forces are re-shaping the new pharmaceutical ecosystem. Technology, demographics, regulations and shifts in wealth are creating transformative change. Increasingly becoming a more patient-centric world, patients use Smart devices to monitor research and evaluate pharmaceutical products. Healthcare reform regulations, the devaluation of the existing pharma model and trend towards patient empowerment and access to information are shaping the changing pharma industry, much as the retail industry was shaped by the multichannel and omni channel retailing trends of recent years. Regulators have become increasingly more cautious when improving innovative medicines. As pharmaceuticals have become more successful in prolonging life and treating illness, many medical conditions are now chronic. Today healthcare providers have become increasingly interested in measuring the outcomes of pharma performance and basing pricing accordingly. There has been a dramatic increase in prescription volume and an increased production and use of generic drugs. Producing pharmaceuticals in other countries can be complicated. Customs, local regulations and other factors impact products and require brands to adapt. Generic pharmaceuticals are becoming the dominant category globally, especially in developing rather than just industrial countries. Adding to the complexity, a large number of pharmaceutical products are made by multiple countries. These factors and the move towards specialty pharmaceuticals and greater production of pharmaceutical products globally have resulted in more pressure on global supply chains. Because supply chains have moved from local to global in operation, even one significant event can interrupt the global supply chain. Events such as hurricanes and typhoons, earthquakes, political and economic upheaval can have serious impacts on global supply chains, adding unforeseen costs and delays. Health care reform magnifies the effect of longer supply chains and increases the intense cost pressure on drug manufacturers. In order to reduce costs, more production as well as research and development are being offshored and outsourced.
Waste in hospitals - everywhere - is massive. Up to 50% of consumables and devices purchased are never used on a patient. Support activities are highly manual, repetitive and done by professional clinical staff...
This presentation sets out the strategic environment and discusses the development and successful implementation of a leading-edge process and supply chain solution for hospitals.
Pfizer is the world's largest pharmaceutical company by revenue. It has over 103,700 employees worldwide and had $67.42 billion in revenue in 2011. In India, Pfizer has over 3,000 employees and a manufacturing facility in Thane, Maharashtra. The pharmaceutical industry is forecast to have 5-8% annual growth to 2015 despite economic challenges. Companies are focusing on supply chain management and cost cutting to drive efficiency. Effective management of transportation, inventory, expiration dates and recalls is important for pharmaceutical supply chains.
This document discusses issues with CAPA (Corrective and Preventive Action) programs and best practices for improvement. It notes that CAPA continues to be a top citation for pharmaceutical companies. It recommends taking a holistic approach to CAPA, with planning, source error tracking across the product lifecycle into a sole database, trend analysis integrated with risk management, and employee training and accountability. With these improvements, companies can better identify and address quality issues.
Corporate Research Project on Pharmaceutical Industry of SingaporeSanket Golechha
This document outlines a capstone research project on logistics and supply chains in the pharmaceutical industry. The project aims to study supply chain regulations and security in Singapore to eliminate counterfeit drugs. The research framework includes examining the pharmaceutical business environment, logistics environment, supply chain complexity, regulations, and counterfeiting risks. Primary research will involve interviews with industry and academic experts. Secondary research methods include reviewing literature, reports, and case studies. Key findings and recommendations will aim to suggest improvements to supply chain security for the pharmaceutical industry in Singapore.
Medical device companies struggle with CAPA compliance due to fragmented and manual systems. An effective CAPA system requires planning, integrated data sources, risk-based prioritization of issues, and trend analysis. It also needs employee training and management processes to monitor performance and drive accountability. A comprehensive electronic CAPA management system can help companies achieve compliance by connecting people, procedures, and data across the organization.
Developing And Executing A Program For Labeling ComplianceChris Miller
The document discusses developing a program for labeling compliance. It notes that labeling has become complex due to increasing regulations from various government bodies. An ideal solution would be one that adapts to regulatory changes and lowers risks of non-compliance. Key aspects of implementing a solution include user training, validation, label design, documentation, and supplier management. The document provides an overview of developing a holistic labeling compliance program.
Pfizer is the world's largest pharmaceutical company with revenues of $49.6 billion in 2014. It has over 78,000 employees worldwide and key products include Lipitor, Lyrica, Viagra, and Celebrex. In India, Pfizer has over 3,000 employees and a manufacturing facility in Thane, Maharashtra. Pfizer utilizes a complex global supply chain network involving over 300 suppliers to procure and deliver materials and finished products to customers in over 175 distribution centers worldwide while managing risks such as cargo theft and counterfeiting.
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.
Impax Announces Agreement to Acquire Generic Products - June 21, 2016impax-labs
Impax announces it has agreed to acquire a portfolio of 18 generic products from an undisclosed party for $586 million in cash. The acquisition expands Impax's portfolio of solid oral, injectable, inhalable, and topical generic drugs. It is expected to add $80 million in revenue and $50 million in EBITDA in the second half of 2016 and be immediately accretive to earnings per share. Impax provides updated 2016 financial guidance incorporating the acquisition, projecting at least 15% revenue growth over 2015 to over $860 million.
Impax provides concise summaries of forward-looking statements and highlights its focus on four key areas:
1) Continued focus on quality to resolve regulatory issues and gain approvals of generic products.
2) Maximization of its generic and specialty pharmaceutical platforms through pipeline of potential launches representing billions in sales.
3) Optimization of its generic research and development pipeline including first-to-file opportunities representing $19 billion in potential sales.
4) Pursuit of business development to accelerate growth including advancement of its next-generation brand pipeline programs.
The document discusses the supply chain of the pharmaceutical industry. It describes the typical supply chain process including raw material sourcing, manufacturing, distribution and dispensing. It highlights several critical issues in managing pharmaceutical supply chains including maintaining temperature control, complex network design, and focus on research and development. It also discusses risks in pharmaceutical supply chains such as uncertainty in demand and the product development pipeline. Finally, it provides an overview of the current distribution system in India which involves clearing and forwarding agents and stockists.
Paper chromatography is a technique used to separate mixtures into individual components. It works by allowing the molecules in a mixture to distribute themselves between a stationary phase (filter paper) and a mobile phase (solvent). Different molecules will travel different distances up the paper depending on how strongly they interact with each phase. Paper chromatography has been replaced in many applications by thin layer chromatography, which provides faster runs and better separation. However, paper chromatography is still useful for teaching chromatography principles in educational settings.
Paper chromatography (PC) was introduced in 1865 and is considered the simplest chromatographic technique. It involves using filter paper as the stationary phase and a solvent as the mobile phase. There are two types of PC - adsorption chromatography where the paper is coated with an adsorbent like silica or alumina, and partition chromatography where moisture in the paper acts as the stationary phase. Compounds are separated based on their partitioning between the stationary and mobile phases. PC is useful for separating mixtures and identifying compounds due to its low cost, simplicity, and good resolving power.
This document discusses thin layer chromatography techniques. It covers topics like adsorbents used for TLC plates, methods for preparing chromatoplates, selecting mobile phases, development techniques like ascending and two-dimensional development. It also discusses detection methods and compares TLC to HPTLC, noting enhancements in HPTLC like pre-conditioning of chambers and multiple development techniques to improve resolution.
Presentation on principle of paper chromatography and Rf ValueManoj Kumar Tekuri
This presentation discusses paper chromatography, including its principle, types, advantages, and calculation of Rf values. Paper chromatography separates compounds based on their differential partitioning between a stationary phase (paper) and mobile phase (solvent). It has advantages like simple equipment and ability to separate closely related compounds. The distance migrated by a compound divided by the distance traveled by the solvent front gives the retention factor (Rf value), which is useful for identification. Factors like solvent composition, temperature, paper quality can influence Rf values.
A separation technique in which the mobile phase is a gas. Gas chromatography is always carried out in a column.
Separating mixtures of gases or volatile materials based primarily on their physical properties.
Thin layer chromatography (TLC) is a method used to separate and analyze mixtures. TLC involves spotting a sample onto a thin layer of adsorbent material like silica gel coated onto a plate. The plate is then placed in a developing chamber with a solvent that carries different components of the mixture at different rates based on their interactions with the stationary and mobile phases. This causes the components to separate into distinct spots on the plate. The spots are then visualized using techniques like UV light or staining reagents to identify the different components of the original mixture. TLC is a simple, fast, and inexpensive technique that can be used to determine purity, identify unknown compounds, monitor reactions, and purify samples.
Chromatography is a technique used to separate mixtures into individual components. It works by using the differential affinities of components for a mobile phase and stationary phase. The document defines chromatography and describes various types including liquid chromatography, gas chromatography, paper chromatography, and thin layer chromatography. It also provides examples of how chromatography is used in fields like pharmaceuticals, forensics, environmental testing, and manufacturing. The rest of the document outlines a paper chromatography experiment using markers to demonstrate how the technique separates dyes based on solubility in solvent solutions.
High Performance Liquid Chromatography (HPLC) is described. HPLC uses high pressure to force a mobile phase through a column at a fast rate, increasing resolution. It discusses the types of chromatography used in HPLC, including normal phase, reverse phase, ion-exchange, and size-exclusion. The instrumentation of HPLC is also summarized, including components like the pump, mixing unit, degasser, injector, column, and detector.
Paper chromatography is a technique introduced in 1865 that separates mixtures by analyzing how compounds partition between a stationary phase (cellulose paper) and a mobile phase (solvent). It is simple and widely used. Compounds are separated based on how they partition between the water in cellulose fibers and an organic solvent. Samples are applied to a line on paper and developed in a chamber saturated with solvent vapors. Compounds form separate spots visualized with detectors like iodine or UV light. Quantification is done by comparing spot intensities to a standard.
Gas chromatography is a technique used to separate and analyze compounds that can be vaporized, with typical uses being testing purity or separating mixture components. It works by having an inert carrier gas move compounds through a column coated with a liquid or polymer stationary phase. Each compound interacts differently with the stationary phase and elutes from the column at different retention times, allowing separation and analysis. Key aspects of gas chromatography include the carrier gas, sample injection port, column temperature control, and various detector types that can identify and quantify the separated compounds.
Thin layer chromatography (TLC) is a technique used to separate mixtures into their components. It involves a stationary phase, such as a silica gel-coated plate, and a mobile phase, which can be a solvent or solvent mixture. Samples are spotted onto the plate and the mobile phase is allowed to travel up the plate, separating the samples based on how strongly they interact with each phase. TLC provides a simple, low-cost method for analyzing mixtures and is useful in fields like pharmaceuticals, biochemistry, and food and cosmetic analysis.
HIGH PERFORMANCE LIQUID CHROMATOGRAPHY (HPLC)Suneal Saini
This document provides an introduction to high performance liquid chromatography (HPLC). It discusses the basic components and principles of HPLC, including the stationary and mobile phases, pumps to move the mobile phase through the column at high pressure, and various detectors used to analyze the separated components as they elute from the column. It also describes the different types of HPLC based on the mode of separation, elution technique, scale of operation, and type of analysis performed.
Thin layer chromatography (TLC) is a simple, inexpensive technique used to separate and identify components in organic compounds. In TLC, compounds are distributed between a stationary phase, like silica gel, and a mobile phase, like a solvent or solvent mixture. As the mobile phase travels up the plate, different components travel at different rates depending on their solubility, allowing separation. Common adsorbents and solvent systems used for lipid separation are described. Various detection reagents can be used to visualize separated components under UV light or by producing colored spots. Examples are given of separations achieved for different lipid classes and subclasses using TLC.
This document discusses various detectors used in gas chromatography. It begins by introducing gas chromatography and its principles of separation. It then describes several common detectors including the thermal conductivity detector, flame ionization detector, electron capture detector, flame photometric detector, argon ionization detector, and nitrogen-phosphorus detector. For each detector, it provides details on its working principle, advantages, disadvantages, and applications. The document concludes by comparing different detectors based on their selectivity, sensitivity and dynamic range.
Thin layer chromatography (TLC) is a chromatography technique used to separate mixtures by distributing the components between a stationary phase, such as silica gel coated on a plate, and a mobile phase, such as a solvent mixture, which moves up the plate by capillary action. TLC involves spotting a sample mixture onto the plate, developing it in a solvent system, and visualizing the separated components, which travel at different rates depending on how they partition between the stationary and mobile phases. TLC is a simple, fast, and inexpensive analytical technique used for qualitative and quantitative analysis of organic compounds and testing compound purity.
Gas chromatography is a technique used to separate and analyze volatile compounds. It works by injecting a sample into a column through which an inert gas flows, carrying the separated components out at different rates depending on their interactions with the stationary phase coating the column. The separated components are detected to produce a chromatogram showing peaks that can be analyzed to determine the identity and quantity of each component in the original sample.
HPLC Principle,Instrumentation and ApplicationAlakesh Pradhan
HPLC Chromatography and its principle
Liquid chromatography
High Performance Liquid Chromatography ( HPLC )
The components of the high performance liquid chromatograph (HPLC).
The separation process.
The chromatogram
Report - Food and Beverage - Improve TraceabilityLoftware
As the food and beverage industry has become more global in scope, health and safety concerns—and regulations—have mounted, and the risk of product recalls has put a greater focus on traceability across the extended food supply chain. Competition is intense to begin with, and mergers and acquisitions intensify it even more so, putting pressure on companies to become more efficient if they want to stay both competitive and profitable. Consumers are more demanding, calling not only for greater variety but for more information on the product they’re consuming. (What’s in it? Where does it come from?) In this environment, as labeling is growing in importance, Enterprise Labeling is providing a powerful new solution that helps companies improve traceability, sustain compliance, reduce costs, and drive overall operational efficiency.
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
What Are the Challenges Faced by Medicine Distributors in the Industry?go4distributors
Medicine distributors must navigate a complex landscape of regulatory requirements that vary from country to country and even within regions of the same country. Compliance with the Food and Drug Administration (FDA) in the United States, the European Medicines Agency (EMA) in Europe, and similar regulatory bodies worldwide involves meticulous documentation, regular audits, and adherence to Good Distribution Practices (GDP). These regulations are essential to ensure the safety and efficacy of pharmaceuticals, but they also add a significant burden to distributors. Non-compliance can result in severe penalties, product recalls, and loss of business licenses, making it a critical challenge for distributors.
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.
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 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.
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.
Serialization: Driving Business Value Beyond ComplianceCognizant
As serialization and track-and-trace capabilities go mainstream to meet regulatory compliance mandates, pharmaceuticals companies should simultaneously explore how these tools and techniques can improve supply chain planning and operations, elevate patient and doctor engagement, and increase sales and marketing effectiveness.
Serialization: Driving Business Value Beyond ComplianceCognizant
Serialization and track-and-trace capabilities are not just useful for meeting regulatory compliance mandates; pharmaceutical companies can also explore their use to improve supply chain planning and operations, elevate patient engagement, and increase sales and marketing effectiveness.
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.
As a very critical industry for the health and well-being of people all over the world, the global food industry is subject to a vast amount of regulations throughout the global supply chain. With ongoing technical progress in automation and data processing, regulations will not only continue to grow, but will also demand more and more input from all participants in the supply chain. To achieve compliance with growing global regulations, it will become necessary
to provide fully traceable evidence about all supply chain movements from raw materials to the finished product. Looking beyond regulations, having full transparency and control over your supply chain can also result in fundamental advantages over the competition. If the available data is used properly, it can be harnessed and leveraged to gain a strategic business advantage including improvements in the overall supply chain procedures and a boost in customer trust and confidence by providing transparency about food origins.
Now is the time to take action and evolve your supply chain strategy...
Now is the time to move beyond simply meeting the minimum expectations of regulatory guidelines and evolve to a more strategic approach to complete supply chain integrity...
Now is the time to keep your company out of the headlines because of a recall or compromised link in your extended supply chain...
The document discusses emerging business and operational models in the pharmaceutical industry. It notes that the traditional vertically integrated model is shifting to a more fragmented model. It also discusses factors driving changes like rising costs and competition. The document analyzes current blockbuster and niche models and potential future models involving more specialization. It proposes a "progressive drug development model" to reduce risks and costs through targeted development.
Over the past several decades, manufacturing has gone through many profound changes. Globalization has resulted in a widely dispersed supply chain, opened up many new markets, introduced a new body of regulations, and greatly intensified competition. Customers today are more knowledgeable about their options, and more demanding of the companies they work with. They’re looking for high quality, delivery as promised, and lightning-fast responsiveness. Technology–automation, robotics, mass customization, 3D printing, the Internet of Things–is altering the production process in many ways.
Today, manufacturing has to move fast. Products become more rapidly obsolescent, and with shorter product lifecycles, manufacturers are less forgiving of hiccups in their supply and distribution chains. Factor in cyclical swings and slowdowns, and the picture becomes even more complex and challenging.
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.
Pharmaceutical Supply Chains Require New Operational and Technology Models to...Cognizant
The pharmaceutical supply chain requires new operational and technology models to enable collaboration and efficiency. Pharmaceutical companies face slowed growth, industry pressures, and declining margins. They must embrace demand-chain thinking and cloud solutions to share real-time data with partners. This will help manage unpredictable demand, gain inventory visibility, and serve diverse markets. Cloud platforms can provide a common space for stakeholders to connect and share data, fostering transparency and accountability.
Is your company ready to meet today’s challenges?Lidia Gasparotto
Visit us online at:
www.ibm.com/electronics/medicaldevices
Is your company ready to meet today’s challenges?
Ask yourself the following questions:
Are your products linked to clinical information systems? •
Is your supply chain optimized to track inventory, handle complaints and •
recalls and manage assets?
Can you comply efficiently with divergent security and privacy regula- •
tions?
Does your company get new products to market as quickly as your •
competitors?
Are your operations efficient and profitable? •
Does your company’s IT environment facilitate the formation of strategic •
alliances with insurance companies, HMOs, hospital buying groups and
supply chain logistics companies?
Can you reduce your tax liabilities through the use of commissionaires?
IBM has developed and refined the tools you need.
McKinsey Sağlık Tedarik Zinciriyle, FMCG Tedarik Zinciri karşılaştırıyor. Sağlık Tedarik Zincirindeki iyileştirme fırsatına ve toplumsal boyutuna dikkat çekiyor.
The document discusses marketing strategies used by pharmaceutical companies. It notes that companies are shifting from acute therapies to focusing more on chronic therapies that require long-term treatment. This allows companies to build more stable customer bases. The document also outlines some of the challenges companies face, such as increased competition, high costs of research and development, and complex decision-making processes involving doctors, patients, and other stakeholders. It discusses two common business models - the "super core model" involving a small number of highly successful chronic drugs, and the "core model" involving marketing a larger number of acute drugs.
The document discusses marketing strategies used by pharmaceutical companies. It notes that companies are shifting from acute therapies to focusing more on chronic therapies. This represents a long-term strategy change as chronic therapies require doctors to prescribe the same drugs for longer periods. The document also outlines some of the challenges pharmaceutical companies face in marketing to different customers in the supply chain from doctors to patients. It discusses strategies around patents, research and development, and pursuing either a "super core" model focused on a small number of chronic drugs or a "core" model marketing more acute drugs.
This document discusses trends in enterprise labeling from a survey of 500 supply chain professionals. The top trends are: 1) Businesses are standardizing labeling for consistency and efficiency across global supply chains; 2) Labeling needs to be integrated with business systems and allow for dynamic, data-driven changes; 3) Labeling intersects the supply chain at all levels from production to distribution; 4) Technology advances like cloud computing are influencing how labeling solutions are deployed and accessed.
Similar to Enterprise Labeling for the Pharmaceutical Industry (20)
Infographic for 2017 Top 5 Trends in Enterprise Labeling Report. Businesses today are relying on labeling professionals for best practices, implementation, training, and knowledge transfer to ensure requirements are met and to eliminate supply chain disruptions
Enterprise Labeling for the Automotive IndustryLoftware
The document discusses how enterprise labeling can help automotive companies address the complex challenges of their global supply chains. It notes that the automotive supply chain is highly complex, with parts sourced globally and assembly occurring thousands of miles away. Enterprise labeling can improve operational efficiency, meet customer and regulatory requirements, and enhance traceability. The document presents examples of large automotive companies that have implemented enterprise labeling solutions to gain benefits such as reduced costs, improved quality and responsiveness to customers.
The survey, which polled approximately
175 professionals from global companies,
uncovered the challenges manufacturing professionals face when it comes to barcode labeling in a global supply chain.
Infographic - Food and Beverage Barcode LabelingLoftware
The survey, which polled approximately 182 professionals from global companies, uncovered the challenges Food & Beverage professionals face when it comes to barcode labeling in a global supply chain.
What is the GHS?
As a response to the multiple definitions of hazard and multiple ways of communicating these hazards, the United Nations adopted the Globally Harmonized System for Classification and Labeling of Chemicals (GHS) in 2003. OSHA’s revised Hazard Communication Standard has presented manufacturers, formulators and distributors with the challenge of revising their Safety Data Sheets (SDSs) and the product labels by June 1, 2015.
Compliance With Udi Labeling Mandates A Proven MethodologyLoftware
There has never been a better or more urgent time for manufacturers of healthcare products to make a close examination of their product labeling systems. Why? Because in most cases, existing solutions were developed over time, usually organically and often departmentally, individually and separately by each manufacturing entity to a labeling standard of their own choice. This approach has mostly worked, albeit at great expense, with much inefficiency, and at the tremendous risk of error, manufacturing interruptions, counterfeit labels and a host of other problems. But in addition to these well-known limitations, there is one additional major reason why now is a good time to explore labeling solution alternatives. New labeling mandates from the FDA – now expected to be imposed no later than September, 2013 – are going to require all healthcare products manufacturers in the United States to adhere to a uniform set of Unique Device Identification (UDI) labeling standards. This means that proprietary labels and any labels that are not part of a universally-accessible database for common use by all other manufacturers and at all checkpoints in any supply chain will, virtually overnight, be a thing of the past in the United States. In fact, it is likely the FDA initiative will further drive the global effort occurring at this time to effect this same kind of UDI solution worldwide.
Unique Device Identification and GS1: Defining Elements in the Future of Glob...Loftware
This white paper, as the title suggests, is about new national and international mandates for a global standard to be used
in the Unique Device Identification (UDI) of medical devices and other healthcare products. It examines the global trading
opportunities, on an enormous scale, that can be captured by early adopters or forfeited by default by those who wait,
dismiss the idea, or discount the powerful market and competitive forces that UDI developments are driving. Also offered
is a starting blueprint for regulatory compliance professionals, packaging engineers, C-suite executives and manufacturing experts who agree the time to start meeting the UDI opportunity has clearly arrived.
This presentation covers the issues around integration, the global preponderance of GS1-compliant markets and the up-coming US Food and Drug Administration regulations on Unique Device Identification.
How to Model the Labeling Requirements In Your Global Supply ChainLoftware
This document outlines five building blocks for understanding how to model labeling requirements in a global supply chain. The building blocks are: 1) centralized labeling control from headquarters, 2) labeling through distribution centers, 3) labeling with third party business partners, 4) labeling at a manufacturing campus, and 5) in-country labeling compliance. The document explains each building block and how Loftware software can be used to implement the different options to meet global supply chain labeling challenges.
Local Advanced Lung Cancer: Artificial Intelligence, Synergetics, Complex Sys...Oleg Kshivets
Overall life span (LS) was 1671.7±1721.6 days and cumulative 5YS reached 62.4%, 10 years – 50.4%, 20 years – 44.6%. 94 LCP lived more than 5 years without cancer (LS=2958.6±1723.6 days), 22 – more than 10 years (LS=5571±1841.8 days). 67 LCP died because of LC (LS=471.9±344 days). AT significantly improved 5YS (68% vs. 53.7%) (P=0.028 by log-rank test). Cox modeling displayed that 5YS of LCP significantly depended on: N0-N12, T3-4, blood cell circuit, cell ratio factors (ratio between cancer cells-CC and blood cells subpopulations), LC cell dynamics, recalcification time, heparin tolerance, prothrombin index, protein, AT, procedure type (P=0.000-0.031). Neural networks, genetic algorithm selection and bootstrap simulation revealed relationships between 5YS and N0-12 (rank=1), thrombocytes/CC (rank=2), segmented neutrophils/CC (3), eosinophils/CC (4), erythrocytes/CC (5), healthy cells/CC (6), lymphocytes/CC (7), stick neutrophils/CC (8), leucocytes/CC (9), monocytes/CC (10). Correct prediction of 5YS was 100% by neural networks computing (error=0.000; area under ROC curve=1.0).
Cell Therapy Expansion and Challenges in Autoimmune DiseaseHealth Advances
There is increasing confidence that cell therapies will soon play a role in the treatment of autoimmune disorders, but the extent of this impact remains to be seen. Early readouts on autologous CAR-Ts in lupus are encouraging, but manufacturing and cost limitations are likely to restrict access to highly refractory patients. Allogeneic CAR-Ts have the potential to broaden access to earlier lines of treatment due to their inherent cost benefits, however they will need to demonstrate comparable or improved efficacy to established modalities.
In addition to infrastructure and capacity constraints, CAR-Ts face a very different risk-benefit dynamic in autoimmune compared to oncology, highlighting the need for tolerable therapies with low adverse event risk. CAR-NK and Treg-based therapies are also being developed in certain autoimmune disorders and may demonstrate favorable safety profiles. Several novel non-cell therapies such as bispecific antibodies, nanobodies, and RNAi drugs, may also offer future alternative competitive solutions with variable value propositions.
Widespread adoption of cell therapies will not only require strong efficacy and safety data, but also adapted pricing and access strategies. At oncology-based price points, CAR-Ts are unlikely to achieve broad market access in autoimmune disorders, with eligible patient populations that are potentially orders of magnitude greater than the number of currently addressable cancer patients. Developers have made strides towards reducing cell therapy COGS while improving manufacturing efficiency, but payors will inevitably restrict access until more sustainable pricing is achieved.
Despite these headwinds, industry leaders and investors remain confident that cell therapies are poised to address significant unmet need in patients suffering from autoimmune disorders. However, the extent of this impact on the treatment landscape remains to be seen, as the industry rapidly approaches an inflection point.
Basavarajeeyam is a Sreshta Sangraha grantha (Compiled book ), written by Neelkanta kotturu Basavaraja Virachita. It contains 25 Prakaranas, First 24 Chapters related to Rogas& 25th to Rasadravyas.
These lecture slides, by Dr Sidra Arshad, offer a quick overview of the physiological basis of a normal electrocardiogram.
Learning objectives:
1. Define an electrocardiogram (ECG) and electrocardiography
2. Describe how dipoles generated by the heart produce the waveforms of the ECG
3. Describe the components of a normal electrocardiogram of a typical bipolar lead (limb II)
4. Differentiate between intervals and segments
5. Enlist some common indications for obtaining an ECG
6. Describe the flow of current around the heart during the cardiac cycle
7. Discuss the placement and polarity of the leads of electrocardiograph
8. Describe the normal electrocardiograms recorded from the limb leads and explain the physiological basis of the different records that are obtained
9. Define mean electrical vector (axis) of the heart and give the normal range
10. Define the mean QRS vector
11. Describe the axes of leads (hexagonal reference system)
12. Comprehend the vectorial analysis of the normal ECG
13. Determine the mean electrical axis of the ventricular QRS and appreciate the mean axis deviation
14. Explain the concepts of current of injury, J point, and their significance
Study Resources:
1. Chapter 11, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 9, Human Physiology - From Cells to Systems, Lauralee Sherwood, 9th edition
3. Chapter 29, Ganong’s Review of Medical Physiology, 26th edition
4. Electrocardiogram, StatPearls - https://www.ncbi.nlm.nih.gov/books/NBK549803/
5. ECG in Medical Practice by ABM Abdullah, 4th edition
6. Chapter 3, Cardiology Explained, https://www.ncbi.nlm.nih.gov/books/NBK2214/
7. ECG Basics, http://www.nataliescasebook.com/tag/e-c-g-basics
Rasamanikya is a excellent preparation in the field of Rasashastra, it is used in various Kushtha Roga, Shwasa, Vicharchika, Bhagandara, Vatarakta, and Phiranga Roga. In this article Preparation& Comparative analytical profile for both Formulationon i.e Rasamanikya prepared by Kushmanda swarasa & Churnodhaka Shodita Haratala. The study aims to provide insights into the comparative efficacy and analytical aspects of these formulations for enhanced therapeutic outcomes.
Promoting Wellbeing - Applied Social Psychology - Psychology SuperNotesPsychoTech Services
A proprietary approach developed by bringing together the best of learning theories from Psychology, design principles from the world of visualization, and pedagogical methods from over a decade of training experience, that enables you to: Learn better, faster!
Promoting Wellbeing - Applied Social Psychology - Psychology SuperNotes
Enterprise Labeling for the Pharmaceutical Industry
1. 1
ENTERPRISE LABELING FOR THE PHARMACEUTICAL INDUSTRY
UNLOCK THE POWER OF LABELING
TO GAIN STRATEGIC EDGE
INDUSTRY REPORT
2. 2
IT’S TIME FOR POWERFUL NEW SOLUTIONS
IN PHARMACEUTICAL LABELING
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.
REGULATORY REQUIREMENTS
In a world of complexity and regulation, few industries are as complex and regulated as pharmaceuticals.
Standards for quality, safety, and procedural accuracy are exceedingly high – as are the stakes – and failure
to meet these standards can have profound consequences, including loss of life.
The global nature of the pharmaceutical industry – with worldwide manufacture and markets – means that
regulations are growing around the globe. In addition, the GS1 System of Standards is aimed at improving
supply chain efficiencies in numerous industries, including pharmaceuticals, and these standards are
continuously evolving.
In the United States, the Food and Drug Administration (FDA) has broad jurisdiction over pharmaceutical
shipments crossing US borders, as well as within the country. For the FDA, labeling violations are the
easiest violations to find. They require no site inspections, no product testing. Mislabeled shipments - where
the label is not correct for a variety of reasons - often result in refusal and/or return of product as well
as hefty customs fines. The FDA also has labeling-related guidelines for GxP (Good x Practices) for the
pharmaceutical industry that should be followed. The Code of Federal Regulations for Electronic Records
and Electronic Signatures, or 21 CFR Part 11, has been set forth as guidance for some time, but now the
electronics transactional data and eSignatures either are or will be required.
The regulation that is greatly impacting pharmaceutical labeling in the US is Title II of the Drug Quality and
Security Act (DQSA), the Drug Supply Chain Security Act (DSCSA). The goal of DSCSA is to create a system
that can trace drugs throughout the supply chain so that legitimate products can be verified, illegitimate
products detected, and drug product recalls facilitated. Provisions covered under DSCSA cover the full
supply chain: manufacturers, wholesaler drug distributers, repackagers, and dispensers. In an ongoing
rollout, the following elements will be part of the comprehensive track and trace plan: product identification,
tracing, and verification; detection and response; notification; wholesaler licensing; and third-party logistics.
All stakeholders will share responsibility for securing the pharmaceutical supply chain to protect providers
and patients, and to guard against mishandling of products through counterfeiting, gray marketing, and
diversion.
3. 3
A WIDELY DISPERSED SUPPLY CHAIN
Beyond satisfying regulatory requirements, there are a number of other challenges in the pharmaceutical
world – challenges that can be met through better labeling. The pharmaceutical supply chain is highly
complex, with many steps, as ingredients are often shipped in bulk, repackaged and reshipped, before
they find their way to the manufacturer producing the branded end-products. Multiple tiers of wholesalers
are often involved. Oftentimes, borders are crossed. Labeling is essential to the smooth flow of the
pharmaceutical supply chain, where problems can arise at any juncture in the chain, or may “wait” to become
manifest only in a finished product.
COMPETITIVE PRESSURES
Within the pharmaceutical industry, global competition is fierce, and competitive pressures – as well
as pressures from health care providers and insurers to keep costs from skyrocketing – result in an
increasing focus on maintaining costs and on operational efficiency. Here, the right labeling approach
can yield big dividends.
MARKET EXPANSION
Entering new markets is essential for success–they’re where many of the opportunities for growth are–but
each new market presents unique challenges–and unique labeling needs, as pharmaceutical companies
must satisfy local language, shipping, and regulatory demands.
TAKING A STRATEGIC PERSPECTIVE ON LABELING
In this world of complexity and regulation, labeling must be viewed from a systemic perspective. Yesterday’s
approach to labeling, often done on an operational and departmental level, with insufficient strategic
planning for organization-wide standards or policies, has resulted in a disparate, piecemeal labeling
“solution” that’s expensive, inefficient, and error-prone. Mislabeled shipments, if the labels aren’t corrected
within a short period of time, are rejected, or languish in customs. Fines may be levied. Lost or faulty product
shipments can’t be tracked, putting pharmaceutical firms at risk. The labeling requirements of trading
partners and customers can’t be easily met. Opportunities to reinforce brand are missed.
Today, forward-thinking global pharmaceutical companies increasingly want to look at labeling from a
strategic, systemic perspective. They recognize that labeling is a critical mechanism for maintaining
compliance, ensuring brand consistency, improving operational efficiency, and supporting business growth.
4. 4
WHAT HAPPENS IN THE ABSENCE OF A STRATEGIC
LABELING PROCESS
Failure to treat labeling as a strategic process can prove costly. Without a strategic approach to labeling,
a pharmaceutical company is likely to experience:
EXCESSIVE REGULATORY COSTS
Pharmaceutical companies must comply with specific regulatory requirements in each market where their
products are sold. New intended uses for a drug must be indicated on labels. This may mean label changes
multiple times each year – changes that must be understood, designed, approved and implemented. Failure
to rapidly respond to regulatory changes results in supply disruptions, lost revenue, and customs fines.
INEFFICIENT ACCESS TO CRITICAL LABEL DATA
Pharmaceutical companies have invested heavily in enterprise-wide business systems. Yet device and
packaging labels are often created using disparate processes that aren’t integrated automatically to sources
of truth residing in key data repositories. The resultant errors, redundancies, inefficiencies and mislabeling
can significantly impact the bottom line.
LOCAL LABELING INEFFICIENCIES
In today’s global supply chains, product design, manufacturing and packaging processes occur in multiple
locations around the world. In the past, label design, control, approval, and printing were driven locally.
While localities were able to comply with regional requirements, the variety of labeling solutions and systems
that resulted often lacked accuracy and were operationally inefficient. This hampered a manufacturer’s
ability to meet broader market requirements in a timely manner, increasing the risk of supply chain disruption
due to regulatory action. It also meant that when a local labeling system was down, production would shut
down as well.
INCONSISTENT BRANDING
Brands convey expertise, innovation, breadth of care, safety, and concern for the patient. Disjointed
labeling processes make it challenging to consistently apply branding guidelines and standards to globally
manufactured and distributed products. This can translate into lost sales, increased regulatory scrutiny,
delayed entry into new markets – and even place patient safety at risk. With the wrong approach to labeling,
for instance, it’s difficult (and perhaps even impossible) to track down recalled product batches.
5. 5
CASE IN POINT
IMPROVING LABELING EFFICIENCY AND ACCURACY BY
REPLACING A TIME-CONSUMING, ERROR-PRONE
MANUAL PROCESS
With over 4,000 employees in 50 countries, and with product distribution in 100 countries
worldwide, this pharmaceutical company has a complex manufacturing and distribution network.
The company recognized that labeling is a critical component of their process. The inability to
identify products can have security, health, and financial impacts. The company printed multiple
labels for a wide range of needs: pallet, loading unit, shipping box, QA/QC, etc. Any new label
design was a major challenge, and modifications to existing labels required a huge effort.
The company is in the process of implementing a global ERP system (Oracle), and chose the
opportunity to deploy an enterprise labeling solution.
TAPPING BUSINESS RULES AND DRAWING ON A SINGLE SOURCE OF TRUTH.
This pharmaceutical manufacturer looked to Loftware to meet their labeling needs. With Loftware,
they have been able to:
• Create a single source of truth by integrating with Oracle ERP system•
Automate a largely manual process, saving time and effort
• Reduce label development times by empowering business us-
ers to easily make required changes, without IT support
• Use sophisticated business rules to drive more consistent and accurate label production
• Easily scale labeling as their business grows
• Keep track of templates and template changes for regulatory purposes
And is also now able to use labeling to help investigate when something has gone wrong in their
supply chain.
6. 6
ACHIEVING STRATEGIC GOALS WITH LOFTWARE’S
ENTERPRISE LABELING SOLUTIONS
By treating labeling as a strategic process – and by implementing an enterprise labeling solution –
pharmaceutical companies are able to achieve consistent branding, reduce regulatory costs, eliminate
data redundancy, and improve overall labeling efficiencies. Loftware Enterprise Labeling Solutions provide
a new level of visibility and control for validated label management. Pharmaceutical manufacturers can
enjoy these benefits:
SINGLE SOURCES OF TRUTH LABELING REDUCES COSTS AND ERRORS
Pharmaceutical companies have invested heavily in enterprise systems that contain single sources
of truth for managing their business and reporting to regulators. Unlike legacy labeling solutions that
maintain off-line data sources (often relying on manual data entry or the use of individual productivity tools
like spreadsheets) and increase the risk of mislabeling, Loftware sources label data directly from single
sources of truth, i.e., from key data repositories, ERP systems, and other applications, utilizing business rules
in its processes. Data replication and synchronization costs and complexity are reduced or eliminated.
INTEGRATED LABEL PROCESSES PROMOTE QUALITY AND EFFICIENCY
When labeling is integrated to the enterprise business processes, as well as with an existing authoring
solution, rather than existing in a stand-alone system, processes are simplified and non-value added
activities are reduced. Loftware enables operators to perform their value-added manufacturing, packaging,
and distribution tasks without having to access separate labeling systems or worry about keeping labeling
synchronized with process or operational data. Loftware software applies business rules to
operational data to automatically determine the right label format, content and device based on the
context of the business transaction.
DATA- AND RULES-DRIVEN LABELING ENABLES RAPID RESPONSE TO CHANGING REGULATIONS
Loftware enables pharmaceutical companies to rapidly respond to changing regional and international
regulatory requirements for labeling, including those being established by DSCSA. By leveraging a
built-in business rules engine, companies can support labeling variations using configurable rules in a
controlled manner, removing the risk of manual errors and mislabeling. Using data-driven label content
and configurable business rules provides the flexibility to address requirements quickly while minimizing
validation and approval activities necessary to implement those label changes into production.
7. CASE IN POINT
REDUCING TCO, WHILE IMPROVING ACCURACY
AND EFFICIENCY WITH LOFTWARE
As a major division of one of the world’s foremost pharmaceutical companies, this manufacturer
understands that labeling plays a critical role throughout the supply chain (manufacturers, labs,
warehouses, etc.) and that without labeling, manufacturing stops. The company deals with many
different label types – incoming materials, weigh-dispense, WIP, sampling labels, shipper box, pallets,
finished goods – which have different layout and data requirements. While specific requirements
may differ, there is a consistent requirement for standardization and consistency, and reliance on
accurate source data. The company recognized that using multiple disparate labeling approaches
was costly to support, challenging to manage, and difficult to adapt to changes. With a goal of
simplifying their labeling landscape, and reducing the Total Cost of Ownership (TCO) for labeling, this
pharmaceutical manufacturer decided to implement an enterprise-wide labeling solution.
With Loftware Enterprise Labeling, this pharmaceutical company is able to:
• Minimize TCO by centralizing labeling and enabling sharing across sites
• Increase label accuracy and quality by integrating with
SAP and creating a single source of truth
• Meet various labeling requirements through use of business rules
• Adapt to expanding and future needs with a scalable solution
• Reduce regulatory burden with GxP compliance company-wide
• Eliminate manufacturing downtime with high-availability labeling architecture
…and are avoiding the risks associated with the use of legacy systems (in-house and old installs),
including the risk of those with knowledge of those systems leaving the company.
8. 8
FLEXIBLE APPROACH HELPS MEET CUSTOMER-SPECIFIC REQUIREMENTS
Organizations within the pharmaceutical supply chain are increasingly required to respond to their customer
and partner labeling demands. These requirements are varied: logo placement or other branding demands,
language variations, location-specific information, country-specific regulations, parts labeling that conforms
to a customer’s existing systems, labeling that enables health care providers to better monitor patient care
and help them achieve faster reimbursement and more. With Loftware, pharmaceutical manufacturers are
able to quickly respond to customers’ requirements, reducing what was once a month-long process to a
matter of a few days.
EASY-TO-USE-INTERFACE EMPOWERS BUSINESS USERS
In the pharmaceutical industry, frequent label changes are a matter of course. New regulations emerge with
increasing frequency. Additional intended uses must be reflected in labeling. Mislabeled shipments languish
in customs. Entering new markets means accommodating new languages and country-specific rules.
Customers or supply chain partners make requests that they’d like to see rapidly met. Branding guidelines
are updated. With Loftware Enterprise Labeling, non-technical business users can quickly make label
changes. This both speeds up the labeling process, and reduces demand on scarce IT resources.
ENTERPRISE LABEL PRINTING SUPPORTS THE GLOBAL ENTERPRISE
Loftware’s Enterprise Labeling Solutions enable pharmaceutical companies to produce labels anywhere in
the global landscape – labels based on approved templates and using common labeling infrastructure. With
an enterprise approach, pharmaceutical companies can ensure consistency by controlling label content and
format including layout, graphics, text and barcodes. In addition to labeling, corporate branding guidelines
can be deployed with minimal time and IT involvement. With Loftware, product labels will project a global
brand image regardless of where products are manufactured, packaged or sold.
DRUG SUPPLY CHAIN SECURITY ACT (DSCSA)
IMPLEMENTATION PLAN
In 2013, the Drug Quality and Security Act (DQSA) was signed into
law. Title II of the DQSA, the Drug Supply Chain Security Act, is aimed
at creating an electronic, interoperable system that will be able to
identify and trace certain prescription drugs distributed within the US.
Track and trace regulations will cover over 70% of pharma by 2017.
The implementation timeframes extend over a 10-year period.
9. 9
A MISSION-CRITICAL PROCESS DEMANDS A MISSION-
CRITICAL SOLUTION
Across the pharmaceutical industry landscape, labeling is increasingly recognized as a mission-critical
process that helps further an organization’s strategic goals. First and foremost: meeting exacting regulatory
compliance standards. This means a labeling solution that supports labeling that is GS1, DSCSA, and
21 CFR Part 11 compliant. In addition to offering labeling that helps ensure compliance, a labeling solution
should be able to stand up to audit demands.
Beyond regulation, pharmaceutical companies require a labeling solution that’s standardized and centralized,
and taps into the data and business rules of existing enterprise systems. Such a solution enables
organizations to become more operationally efficient – saving on costs, avoiding expensive mistakes, and
ensuring that even the most remote facility is in compliance with governmental and industry regulations,
while also meeting overall internal branding standards.
That’s why some of the world’s foremost pharmaceutical manufacturers rely on Loftware to help them take a
strategic approach to labeling.
See how Loftware can provide you a competitive edge to stay compliant while improving the bottom line.
Visit www.loftware.com and keep up with the latest industry news by subscribing to our Blog.
10. PORTSMOUTH, NH, US • GERMANY • UK • SINGAPORE WWW.LOFTWARE.COM
Loftware, Inc. (www.loftware.com) is the global market leader in Enterprise Labeling
Solutions with more than 5,000 customers in over 100 countries. Offering the industry’s most
comprehensive labeling solution, Loftware’s enterprise software integrates SAP®, Oracle®
and other enterprise applications to produce mission-critical barcode labels, documents, and
RFID Smart tags across the supply chain. Loftware’s design, native print, and built-in business
rules functionality drives topline revenue, increases customer satisfaction, and maximizes
supply chain efficiency for customers. With over 25 years of industry leadership, Loftware’s
Enterprise Labeling Solutions and best practices enable leading companies to meet their
customer-specific and regulatory requirements with unprecedented speed and agility.