The document discusses how automated systems can help improve food safety in the processing industry. It notes that while automation has increased production efficiency, there have still been many food safety failures. An automated food safety management system could help companies by standardizing procedures, improving traceability and transparency throughout the supply chain, enabling real-time trend analysis across all processes and products, and reducing risks and costs from failures and recalls. Implementing automated systems that track errors, schedule audits, and analyze data could help address current inefficiencies and systemic problems in ensuring food safety.
The document discusses the challenges faced by contract formulation laboratories in meeting increasing demands from pharmaceutical companies to rapidly develop new drugs while maintaining high quality and regulatory compliance standards. It outlines some of the key pressures contract labs face, including tight timelines, changing regulations, and managing resources effectively. It then provides an example of a university-affiliated contract lab, CUPSI, that enforces strict GMP training and procedures for students. The document concludes that as demands increase, contract labs need integrated quality management systems to streamline documentation, improve compliance, and reduce costs and risks.
The document discusses the need for medical device manufacturers to comply with ISO 13485:2003 quality standards. It notes that situations like Medtronic paying $268 million to settle lawsuits over faulty defibrillator leads emphasize the importance of standards to ensure quality and manage risk. ISO 13485:2003 provides requirements for a quality management system to consistently meet customer and regulatory requirements. It shifts the focus from end-of-production quality inspection to quality control throughout the production process. Following the standard helps manufacturers realize better quality, cost-effectiveness and time to market for their medical devices.
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.
Implementing a quality management system (QMS) provides regulatory benefits, improves market positioning, and enables continuous improvement. Regulatory bodies in the EU and US recognize QMS standards like ISO 13485 for medical devices. A QMS also increases customer satisfaction, reduces costs, and strengthens competitiveness. Continuous improvement, including preventative action, is a key benefit but also often underutilized aspect of a QMS. While establishing a QMS requires time and money for training and certification, the long-term advantages make it worthwhile for companies.
SMi Group's Pre-filled Syringes West Coast 2020 conferenceDale Butler
This document provides an agenda for the 5th annual Pre-Filled Syringes West Coast conference taking place June 15-17, 2020 in San Diego, CA. The conference will focus on innovations in device design and technology, advances in human factors engineering, combination product regulatory insights, and design controls and risk management. It will feature presentations from industry leaders at companies like Genentech and AstraZeneca as well as regulators from the FDA. There will also be two post-conference workshops on June 17th focusing on navigating FDA requirements for connected devices and digital health, and post-market safety reporting for combination products.
Your Best Recall is the One You Never Have to DoSparta Systems
This document discusses product recalls and the importance of managing quality across the supply chain. It notes that recalls have significantly increased since 2006 and about half are due to issues with suppliers or contract manufacturers. Recalls can cost companies between $10-90 million on average. The document then provides an example of the peanut corporation of America recall that cost over $1 billion. It emphasizes that identifying issues earlier in the supply chain reduces costs according to Deming's 1-10-100 rule. The rest of the document discusses how companies can implement strategies like HACCP and supplier relationship management to proactively monitor quality and ensure compliance across the extended supply chain using a quality management system.
The document provides an overview of MedAccred, an industry-managed supplier quality accreditation program focusing on critical manufacturing processes for medical devices. It describes the benefits of MedAccred accreditation for both OEM subscribers and suppliers. Key points include that MedAccred aims to improve quality and consistency through standardized audits of critical suppliers, reducing risk and costs for OEMs while increasing opportunities for accredited suppliers. The audit process and requirements for initial and ongoing accreditation are summarized.
Life Sciences benchmark survey on enabling technology used to support Quality Management Systems. The Benchmark Survey collected responses from LinkedIn's Quality & Regulatory Network.
The document discusses the challenges faced by contract formulation laboratories in meeting increasing demands from pharmaceutical companies to rapidly develop new drugs while maintaining high quality and regulatory compliance standards. It outlines some of the key pressures contract labs face, including tight timelines, changing regulations, and managing resources effectively. It then provides an example of a university-affiliated contract lab, CUPSI, that enforces strict GMP training and procedures for students. The document concludes that as demands increase, contract labs need integrated quality management systems to streamline documentation, improve compliance, and reduce costs and risks.
The document discusses the need for medical device manufacturers to comply with ISO 13485:2003 quality standards. It notes that situations like Medtronic paying $268 million to settle lawsuits over faulty defibrillator leads emphasize the importance of standards to ensure quality and manage risk. ISO 13485:2003 provides requirements for a quality management system to consistently meet customer and regulatory requirements. It shifts the focus from end-of-production quality inspection to quality control throughout the production process. Following the standard helps manufacturers realize better quality, cost-effectiveness and time to market for their medical devices.
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.
Implementing a quality management system (QMS) provides regulatory benefits, improves market positioning, and enables continuous improvement. Regulatory bodies in the EU and US recognize QMS standards like ISO 13485 for medical devices. A QMS also increases customer satisfaction, reduces costs, and strengthens competitiveness. Continuous improvement, including preventative action, is a key benefit but also often underutilized aspect of a QMS. While establishing a QMS requires time and money for training and certification, the long-term advantages make it worthwhile for companies.
SMi Group's Pre-filled Syringes West Coast 2020 conferenceDale Butler
This document provides an agenda for the 5th annual Pre-Filled Syringes West Coast conference taking place June 15-17, 2020 in San Diego, CA. The conference will focus on innovations in device design and technology, advances in human factors engineering, combination product regulatory insights, and design controls and risk management. It will feature presentations from industry leaders at companies like Genentech and AstraZeneca as well as regulators from the FDA. There will also be two post-conference workshops on June 17th focusing on navigating FDA requirements for connected devices and digital health, and post-market safety reporting for combination products.
Your Best Recall is the One You Never Have to DoSparta Systems
This document discusses product recalls and the importance of managing quality across the supply chain. It notes that recalls have significantly increased since 2006 and about half are due to issues with suppliers or contract manufacturers. Recalls can cost companies between $10-90 million on average. The document then provides an example of the peanut corporation of America recall that cost over $1 billion. It emphasizes that identifying issues earlier in the supply chain reduces costs according to Deming's 1-10-100 rule. The rest of the document discusses how companies can implement strategies like HACCP and supplier relationship management to proactively monitor quality and ensure compliance across the extended supply chain using a quality management system.
The document provides an overview of MedAccred, an industry-managed supplier quality accreditation program focusing on critical manufacturing processes for medical devices. It describes the benefits of MedAccred accreditation for both OEM subscribers and suppliers. Key points include that MedAccred aims to improve quality and consistency through standardized audits of critical suppliers, reducing risk and costs for OEMs while increasing opportunities for accredited suppliers. The audit process and requirements for initial and ongoing accreditation are summarized.
Life Sciences benchmark survey on enabling technology used to support Quality Management Systems. The Benchmark Survey collected responses from LinkedIn's Quality & Regulatory Network.
How to Assess New Technology - OMTEC 2017April Bright
Creating robust product pipelines is a top priority for most global orthopaedic device companies, yet our industry’s commercial success rate for new product launches remains less than 20%. Traditionally one of the largest contributors to the less-than-stellar success rate is failure in the very first steps of the development process: a new technology assessment. We will examine the ways that companies address challenges associated with new technology assessments, and some of the key lessons learned.
TransCelerate Overview - Quality Management System Initiave TransCelerate
TransCelerate BioPharma is a non-profit organization whose mission is to collaborate across the biopharmaceutical industry to identify and implement solutions to improve the delivery of new medicines. The Quality Management System initiative aims to advance quality management across the industry by developing a conceptual framework for clinical quality management systems. The initiative has published several papers outlining its frameworks and tools. Its upcoming milestones include releasing additional tools and publishing additional framework papers on risk management and processes.
Pharmaceutical industry is a very vital segment of the
our health care system, which deals with manufacturing
and marketing of pharmaceuticals and biological
products and medicinal devices, used for the diagnosis
and treatment of diseases as well as conducts research
for development of new products for human welfare
TQM involves
building quality in a pharmaceutical product as it
involve complete records such as standard operating
procedures for every step, validation records, master
formula records and batch production records etc.
This document discusses Good Manufacturing Practices (GMP) for pharmaceutical products as outlined by the World Health Organization (WHO). It provides definitions and explanations of key GMP concepts including quality assurance, quality management, and ensuring consistent production of pharmaceuticals according to appropriate quality standards. It also discusses WHO involvement in establishing GMP guidelines and differences between GMP and current Good Manufacturing Practice (cGMP). The document outlines basic GMP principles for quality management, sanitation, qualification and validation, complaints and recalls, and more. It emphasizes that quality failures can result in regulatory warnings, market withdrawals, supply disruptions, and loss of credibility with patients and regulators.
This document summarizes a presentation on quality metrics and culture given at Habib University in Karachi. It discusses key quality metrics like lot acceptance rate, product complaint rate, and CAPA effectiveness. It also identifies attributes of a strong quality culture like leadership emphasis, message credibility, peer involvement, and employee ownership. Finally, it stresses that quality is everyone's responsibility and a mature quality system relies on systems thinking and a culture that prioritizes quality and continuous improvement.
Adherence to the Cuurent Good manufacturing Practices (CGMP) Regulations in t...Obaid Ali / Roohi B. Obaid
The document discusses several key challenges facing the pharmaceutical industry in adhering to CGMP regulations and SOP compliance. It notes that simply trying to meet standards is not enough and that human factors must be considered more closely in designing manufacturing processes using insights from behavioral economics. Industry is often trapped in a "file first, figure it out later" mindset. The document also highlights progress being made in areas like QbD and PAT-based manufacturing that can help address issues if more widely adopted. Overall, it argues the industry must overcome its natural immunity to change by better accounting for human behaviors and designing quality management systems in a more human-centric way.
Performance metrics are an essential element of the management review process.
Quality metrics may include elements such as customer satisfaction, supplier performance, manufacturing defects, complaints, cycle times and many other internal or external processes.
This presentation provides a framework for establishing right quality indicators for evaluating the performance of the quality system.
Quality Metrics are used to monitor the overall quality of pharmaceutical products and helps to improve product quality and implementing the culture in manufacturing facility.
7 Strategies for Building a Culture of Quality in Manufacturing - Paul A. Arr...marcus evans Network
The medical device industry is facing increased challenges such as cost constraints, decreased spending, and new regulations. Paul Arrendell advises that companies must promote a culture of quality by understanding regulations, validating processes, making quality decisions, and integrating quality throughout the business. He discusses seven strategies for building a quality culture, including design and reliability engineering, robust post-production monitoring, supplier management, quality metrics, incorporating quality into roles and incentives, and learning from other companies' mistakes. Arrendell was speaking at the marcus evans Medical Device Manufacturing and R&D Summits in June 2014.
Achieving Quality and Compliance Excellence in PharmaceuticalsAlicia Tébar
This document provides an introduction to a master class guide on achieving quality and compliance excellence in pharmaceuticals. It contains contributions from various experts in the pharmaceutical industry on topics related to quality assurance, compliance, and regulatory affairs. The editor's goal is to help pharmaceutical professionals implement robust quality systems and ensure adherence to regulations. The book is intended to provide guidance on all aspects of quality and compliance for drug products and operations.
Maetrics: The ROI of Good Quality & ComplianceGeneris
The document discusses investing in quality and compliance programs to justify costs. It outlines how to quantify direct and indirect quality costs, examines the FDA's increasing focus on medical devices, and explores the impacts of non-compliance. Proactive quality systems can reduce costs compared to reactive systems. Good investments include dedicated CAPA resources, risk management programs, quality metrics, and harmonizing quality systems during acquisitions.
This webinar discusses establishing a reduced testing program for incoming components in accordance with GMP quality principles and regulations. It will review the reduced testing lifecycle, including specifications, supplier qualification, auditing, and validation. Examples will demonstrate how to design systems to reduce costs while ensuring compliance. Attendees will learn how to qualify suppliers, control specifications, and reduce testing while maintaining quality. The speaker has 30+ years of experience implementing quality systems and will discuss applying quality assurance principles to medical devices and pharmaceuticals.
Campden BRI and Alchemy in partnership with BRC, SGS, SQF and TSI have released the results of the fourth annual global survey of food safety training. The survey questioned food and drink manufacturers and processors worldwide to identify the needs, effectiveness and challenges of food safety training in the industry.
The results reveal some interesting trends:
Improving food safety culture was the top training goal for almost 80% of those surveyed
Many companies are not exploiting the specialist expertise available in their HR departments
Traditional training methods are still favored over online methods
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.
Course Objectives:
How does industry use Metrics?
FDA Challenges and Requirements and Use of Quality Metrics
Complexities of Implementation (Industry Feedback)
What does it all mean?
Key in Risk identification – systematic use of information to identify potential sources of harm (hazards)
referring to the risk question or problem description.
Enables the detection of potential problems as early as possible to plan corrective and preventive
actions
Provides indication that controls are losing effectiveness Important in achieving problem resolution and problem prevention
Another important concept of modern quality systems is the use of trending to examine processes as a whole.
Driving wrong behaviors and unintended consequence
• Establishing excessive or overly complex metrics
Comparing data that is not consistently defined or comparison of single data values
Using metrics as a quality “surrogate”
RCM Technologies (NASDAQ: RCMT) is a premier provider of business and technology solutions uniquely designed to enhance and maximize operational performance for over 35 years. RCM helped a Fortune 100 pharmaceutical company remediate its computer systems to comply with FDA consent decrees, assessing documentation, identifying issues, and validating a major system release with new processes. RCM experts completed the assessment ahead of schedule and under budget, and supported quality assurance initiatives through expertise, consistency, immediate productivity and cultural alignment.
This document outlines areas for research to advance Good Manufacturing Practices in the 21st century. It discusses investigating and evaluating novel manufacturing methods and their impact on product failure rates and quality. It also addresses developing improved analytical methods to evaluate product quality using emerging technologies, and developing sensitive methods to detect and reduce microbial contamination. The overall goals are to enable development and evaluation of important manufacturing improvements, lower the cost of manufacturing, and improve the ability of regulatory agencies to ensure safety, quality and efficacy.
1) The document announces a training session on Good Manufacturing Practices (GMP) of the 21st century to be held on April 4th, 2021. It discusses how GMP standards have evolved over time to focus more on product development, process understanding and control strategies.
2) GMP via a quality management system is important for ensuring drug quality and preventing errors, as testing a small sample cannot guarantee the quality of an entire batch. Advances in technology are reshaping GMP requirements.
3) The training methodology will include tutorials, interactive discussions, and real-world case studies to describe regulatory expectations and keep learning objectives aligned. Participants will be assessed in real-time.
This document summarizes a full day workshop on quality culture for success. It discusses the importance of quality culture in ensuring product quality and safety. Quality culture is defined as an environment where everyone understands the importance of product quality and patient safety. It is the single most important indicator for delivering quality drugs. However, quality culture does not happen by accident - it must be intentionally created through relevant processes, controls, and behaviors that are understood and followed. The document provides examples of how quality culture can be measured and discusses the criticality of quality culture and how to maintain it despite pressures to reduce costs. It outlines potential symptoms and actions if an organization lacks a strong quality culture.
Cleaning validation for the 21 th century pharmaceutical onlineEmma Aguinaga
This eBook is a collection of articles written from May of 2017 through August 2018 and are part of the cleaning validation for the "Cleaning Validation for teh 21 st Century" series.
1) Food, beverage, and CPG manufacturers need to take a holistic approach to quality that touches every aspect of manufacturing and the supply chain. When quality is embraced as a core competency, the organization transforms how it operates.
2) Being prepared for potential product recalls is critical, as recalls can be very costly. Companies need recall plans in place and technology to accurately track ingredients to quickly contain issues and limit the scope of recalls.
3) Manufacturers also need robust traceability systems to gather and provide consumers with information about products and supply chains to meet demands for transparency and influence purchasing decisions. Advanced tracking technology helps ensure quality, support marketing claims, and improve recall readiness.
How to Assess New Technology - OMTEC 2017April Bright
Creating robust product pipelines is a top priority for most global orthopaedic device companies, yet our industry’s commercial success rate for new product launches remains less than 20%. Traditionally one of the largest contributors to the less-than-stellar success rate is failure in the very first steps of the development process: a new technology assessment. We will examine the ways that companies address challenges associated with new technology assessments, and some of the key lessons learned.
TransCelerate Overview - Quality Management System Initiave TransCelerate
TransCelerate BioPharma is a non-profit organization whose mission is to collaborate across the biopharmaceutical industry to identify and implement solutions to improve the delivery of new medicines. The Quality Management System initiative aims to advance quality management across the industry by developing a conceptual framework for clinical quality management systems. The initiative has published several papers outlining its frameworks and tools. Its upcoming milestones include releasing additional tools and publishing additional framework papers on risk management and processes.
Pharmaceutical industry is a very vital segment of the
our health care system, which deals with manufacturing
and marketing of pharmaceuticals and biological
products and medicinal devices, used for the diagnosis
and treatment of diseases as well as conducts research
for development of new products for human welfare
TQM involves
building quality in a pharmaceutical product as it
involve complete records such as standard operating
procedures for every step, validation records, master
formula records and batch production records etc.
This document discusses Good Manufacturing Practices (GMP) for pharmaceutical products as outlined by the World Health Organization (WHO). It provides definitions and explanations of key GMP concepts including quality assurance, quality management, and ensuring consistent production of pharmaceuticals according to appropriate quality standards. It also discusses WHO involvement in establishing GMP guidelines and differences between GMP and current Good Manufacturing Practice (cGMP). The document outlines basic GMP principles for quality management, sanitation, qualification and validation, complaints and recalls, and more. It emphasizes that quality failures can result in regulatory warnings, market withdrawals, supply disruptions, and loss of credibility with patients and regulators.
This document summarizes a presentation on quality metrics and culture given at Habib University in Karachi. It discusses key quality metrics like lot acceptance rate, product complaint rate, and CAPA effectiveness. It also identifies attributes of a strong quality culture like leadership emphasis, message credibility, peer involvement, and employee ownership. Finally, it stresses that quality is everyone's responsibility and a mature quality system relies on systems thinking and a culture that prioritizes quality and continuous improvement.
Adherence to the Cuurent Good manufacturing Practices (CGMP) Regulations in t...Obaid Ali / Roohi B. Obaid
The document discusses several key challenges facing the pharmaceutical industry in adhering to CGMP regulations and SOP compliance. It notes that simply trying to meet standards is not enough and that human factors must be considered more closely in designing manufacturing processes using insights from behavioral economics. Industry is often trapped in a "file first, figure it out later" mindset. The document also highlights progress being made in areas like QbD and PAT-based manufacturing that can help address issues if more widely adopted. Overall, it argues the industry must overcome its natural immunity to change by better accounting for human behaviors and designing quality management systems in a more human-centric way.
Performance metrics are an essential element of the management review process.
Quality metrics may include elements such as customer satisfaction, supplier performance, manufacturing defects, complaints, cycle times and many other internal or external processes.
This presentation provides a framework for establishing right quality indicators for evaluating the performance of the quality system.
Quality Metrics are used to monitor the overall quality of pharmaceutical products and helps to improve product quality and implementing the culture in manufacturing facility.
7 Strategies for Building a Culture of Quality in Manufacturing - Paul A. Arr...marcus evans Network
The medical device industry is facing increased challenges such as cost constraints, decreased spending, and new regulations. Paul Arrendell advises that companies must promote a culture of quality by understanding regulations, validating processes, making quality decisions, and integrating quality throughout the business. He discusses seven strategies for building a quality culture, including design and reliability engineering, robust post-production monitoring, supplier management, quality metrics, incorporating quality into roles and incentives, and learning from other companies' mistakes. Arrendell was speaking at the marcus evans Medical Device Manufacturing and R&D Summits in June 2014.
Achieving Quality and Compliance Excellence in PharmaceuticalsAlicia Tébar
This document provides an introduction to a master class guide on achieving quality and compliance excellence in pharmaceuticals. It contains contributions from various experts in the pharmaceutical industry on topics related to quality assurance, compliance, and regulatory affairs. The editor's goal is to help pharmaceutical professionals implement robust quality systems and ensure adherence to regulations. The book is intended to provide guidance on all aspects of quality and compliance for drug products and operations.
Maetrics: The ROI of Good Quality & ComplianceGeneris
The document discusses investing in quality and compliance programs to justify costs. It outlines how to quantify direct and indirect quality costs, examines the FDA's increasing focus on medical devices, and explores the impacts of non-compliance. Proactive quality systems can reduce costs compared to reactive systems. Good investments include dedicated CAPA resources, risk management programs, quality metrics, and harmonizing quality systems during acquisitions.
This webinar discusses establishing a reduced testing program for incoming components in accordance with GMP quality principles and regulations. It will review the reduced testing lifecycle, including specifications, supplier qualification, auditing, and validation. Examples will demonstrate how to design systems to reduce costs while ensuring compliance. Attendees will learn how to qualify suppliers, control specifications, and reduce testing while maintaining quality. The speaker has 30+ years of experience implementing quality systems and will discuss applying quality assurance principles to medical devices and pharmaceuticals.
Campden BRI and Alchemy in partnership with BRC, SGS, SQF and TSI have released the results of the fourth annual global survey of food safety training. The survey questioned food and drink manufacturers and processors worldwide to identify the needs, effectiveness and challenges of food safety training in the industry.
The results reveal some interesting trends:
Improving food safety culture was the top training goal for almost 80% of those surveyed
Many companies are not exploiting the specialist expertise available in their HR departments
Traditional training methods are still favored over online methods
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.
Course Objectives:
How does industry use Metrics?
FDA Challenges and Requirements and Use of Quality Metrics
Complexities of Implementation (Industry Feedback)
What does it all mean?
Key in Risk identification – systematic use of information to identify potential sources of harm (hazards)
referring to the risk question or problem description.
Enables the detection of potential problems as early as possible to plan corrective and preventive
actions
Provides indication that controls are losing effectiveness Important in achieving problem resolution and problem prevention
Another important concept of modern quality systems is the use of trending to examine processes as a whole.
Driving wrong behaviors and unintended consequence
• Establishing excessive or overly complex metrics
Comparing data that is not consistently defined or comparison of single data values
Using metrics as a quality “surrogate”
RCM Technologies (NASDAQ: RCMT) is a premier provider of business and technology solutions uniquely designed to enhance and maximize operational performance for over 35 years. RCM helped a Fortune 100 pharmaceutical company remediate its computer systems to comply with FDA consent decrees, assessing documentation, identifying issues, and validating a major system release with new processes. RCM experts completed the assessment ahead of schedule and under budget, and supported quality assurance initiatives through expertise, consistency, immediate productivity and cultural alignment.
This document outlines areas for research to advance Good Manufacturing Practices in the 21st century. It discusses investigating and evaluating novel manufacturing methods and their impact on product failure rates and quality. It also addresses developing improved analytical methods to evaluate product quality using emerging technologies, and developing sensitive methods to detect and reduce microbial contamination. The overall goals are to enable development and evaluation of important manufacturing improvements, lower the cost of manufacturing, and improve the ability of regulatory agencies to ensure safety, quality and efficacy.
1) The document announces a training session on Good Manufacturing Practices (GMP) of the 21st century to be held on April 4th, 2021. It discusses how GMP standards have evolved over time to focus more on product development, process understanding and control strategies.
2) GMP via a quality management system is important for ensuring drug quality and preventing errors, as testing a small sample cannot guarantee the quality of an entire batch. Advances in technology are reshaping GMP requirements.
3) The training methodology will include tutorials, interactive discussions, and real-world case studies to describe regulatory expectations and keep learning objectives aligned. Participants will be assessed in real-time.
This document summarizes a full day workshop on quality culture for success. It discusses the importance of quality culture in ensuring product quality and safety. Quality culture is defined as an environment where everyone understands the importance of product quality and patient safety. It is the single most important indicator for delivering quality drugs. However, quality culture does not happen by accident - it must be intentionally created through relevant processes, controls, and behaviors that are understood and followed. The document provides examples of how quality culture can be measured and discusses the criticality of quality culture and how to maintain it despite pressures to reduce costs. It outlines potential symptoms and actions if an organization lacks a strong quality culture.
Cleaning validation for the 21 th century pharmaceutical onlineEmma Aguinaga
This eBook is a collection of articles written from May of 2017 through August 2018 and are part of the cleaning validation for the "Cleaning Validation for teh 21 st Century" series.
1) Food, beverage, and CPG manufacturers need to take a holistic approach to quality that touches every aspect of manufacturing and the supply chain. When quality is embraced as a core competency, the organization transforms how it operates.
2) Being prepared for potential product recalls is critical, as recalls can be very costly. Companies need recall plans in place and technology to accurately track ingredients to quickly contain issues and limit the scope of recalls.
3) Manufacturers also need robust traceability systems to gather and provide consumers with information about products and supply chains to meet demands for transparency and influence purchasing decisions. Advanced tracking technology helps ensure quality, support marketing claims, and improve recall readiness.
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.
The document discusses the importance of food safety management programs in retail food businesses. It argues that an effective program requires commitment from organizational leadership, appropriate structure and resources, and knowledge of foodborne illness hazards that could arise from business operations. A key responsibility of the food safety management team is to define risks by investigating hazards in all areas of the business, including suppliers and retail food preparation. This helps ensure the business is prepared for potential food safety issues rather than learning about risks only after problems occur.
1. Process analytical technology (PAT) aims to shift pharmaceutical development and manufacturing from testing quality through sampling to building quality into products using continuous monitoring and control strategies.
2. PAT involves establishing quantitative relationships between raw materials, process parameters, and product quality attributes to decrease variability, contamination, and costs while improving quality.
3. The goals of PAT include encouraging innovation through a risk-based regulatory framework that facilitates new manufacturing technologies and ensures consistent application of regulations.
How can Food Safety Practitioners prepare for the FSMA Regulations?Beth Mitchell
The document discusses how food safety practitioners can prepare for new FSMA regulations. Key points:
1) The FSMA represents the biggest reform of US food safety laws in over 70 years, shifting the focus from responding to contamination to preventing it.
2) The new regulations include requirements for hazard analysis and preventive controls, environmental monitoring, supplier verification, recall plans, and ensuring qualified staff.
3) Companies must improve processes, documentation, communication and ensure competent staff understand hazards and controls to comply with the risk-based regulations. Independent certification helps verify effectiveness and drive continuous improvement.
“Pharmaceutical Quality Matrices in determining overall state of Quality and ...Marcep Inc.
Introduction to Quality Matrices
•What is Quality metrics
Background&Glossary
•Modernization of Regulatory Oversight of Drug Quality and Promotion of Post-Approval Improvements
•Use of Quality Metrics by FDA for Risk-Based Inspection Scheduling and Prediction of Drug Shortages
Legal authority
•Records Associated with the Process Validation Lifecycle and PQS Assessment
•Authority to Inspect Records and Request in Advance of or In Lieu of an Inspection
The Use of Quality Metrics and Effect of Non-Reporting
•How FDA Intends to Use Quality Metrics
•Effect of Non-Reporting
Group Discussion:
Implementing Trending of Quality Indices in Your Organization
The importance of the right culture and people
• Role of leadership in trending of Quality Indices
• Developing anonline data base for Quality Indices
•Analysis, interpretation and reporting of Quality Indices
The Process Flow
• Establishing the ground rules, procedures, forms and mechanismfor data collection for Quality indices
• Determining responsibilities and roles for the implementation of trending of Quality Indices
Starting the Quality Indices Management Process
•Review of Quality Indices and Gap evaluation
•Preparation of Data bases for Data acquisition
•Collection data for completeness and Accuracy
•Processing and Reporting of Quality Metrics
Day Two
Reporting of Quality data and Calculation of Quality Metrics
• Who Reports and Who May Contribute to the Report
• Quality Metrics that FDA Intends to Calculate
• What Quality Data Would Be Reported
• How to Report Quality Data to FDA
Instructions for Quality Metric Data Submission
•Worksheet for Data Tables
•Product Specific Information
•Mandatory Data •ICH Q9
•Optional Metrics
Recognizing and Understanding the Trending of Quality Indices
Working Session, I:
•Participants will be divided into groups and given acase study and be asked to perform a trend analysis on a given data. Each group will present theresults of its analysis
Working Session II:
•Participants will be divided into groups and given acase study and be asked to perform a trend analysis and propose a Quality metric by using Risk Based approach for the specific set of data. The results of the analyses willbe shared in the class.
Complexities of Implementation Quality Metrics
•Overcoming the pitfalls
•Benefits and Risks
General Discussion and Questions
This document describes the application of Hazard Analysis and Critical Control Points (HACCP) quality control method to the production of pastry products without yeast. It identifies potential hazards in the production process and establishes critical control points to monitor and control hazards. Key points include identifying raw materials and the production process, establishing physicochemical and microbiological standards for the finished product, and procedures for verifying and reviewing the HACCP plan on a regular basis to ensure food safety.
This document discusses quality risk management standard operating procedures (SOPs). It provides links to additional quality management resources and outlines the contents of a quality risk management SOP, including quality risk management principles, tools like check sheets and control charts, and ensuring focus on protecting patients.
Why validation matters: A Brief Guide to a Critical Aspect of the Pharmaceut...Barry Peters
Validation is a critical process in the pharmaceutical manufacturing lifecycle to ensure quality and safety. It involves proving all aspects of manufacturing and distribution that impact quality, from facilities and equipment to software and risk management. The FDA provides recommendations for validation at all stages and inspects manufacturers' processes. Validation demonstrates processes are capable of consistently producing quality products. It is a legal requirement and important for reducing recalls, lawsuits, and investigations. Thorough documentation is needed to show validation was properly carried out across the entire product lifecycle.
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Automated HACCP can Improve Safety
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Automated HACCP Can Improve Safety
August 15, 2010 • By Nikki Willett
The food processing industry has done an incredible job of building new industrial
automation systems to improve overall production processes, reduce time and cost of
production, and increase overall throughput, product yields, and e ciency. In the past
18 months, however, the industry has seen an unprecedented number of supply chain
safety and quality failures.
In 2008, annual nationwide estimates held steady at 87 million cases of food-related
illnesses, with 371,000 hospitalizations and 5,700 deaths, according to the Centers for
Disease Control and Prevention (CDC). These statistics have fueled a reduction in overall
consumer con dence and increased scrutiny by Senate committees and a number of
domestic and international government agencies and groups.
Food processing companies also face the continuing challenge of maximizing food
safety while complying with a growing number of regulations: ISO 22000, FDA 21 CFR
Part 110, the FDA Bioterrorism Act of 2002, hazard analysis and critical control points
(HACCP), safe quality foods (SQF), and others. Timely information about supplier
controls and the production process is needed to adequately analyze and detect
problematic processing trends and take immediate corrective action when needed.
Because the food processing industry is dependent on extended supply chains with
multiple vendors, several variables can have a negative impact on the process, including
increasing prices, diverse standards among suppliers, geographic distance, and tight
timelines. Even though risk and quality management are critical, most organizations still
use a paper-based approach for their food safety and quality management system.
They generate and track myriad paper-based documents within a process that leads to
resource overload, untimely data, and ine ciencies. The long-term e ects of such a
system range from enormous costs for failures due to recalls and suspensions to loss
of retail and consumer con dence.
The food industry must improve its safety record to maintain the good faith of
consumers. Yet even with more focus on quality, problems continue, including:
contamination of raw materials prior to or during processing;
unclean equipment and lack of preventive maintenance;
insu cient employee training; and
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incorrect labeling or packaging.
Fragmented Processes and Systemic Problems
These problems persist for several reasons: Processes are fragmented and
disconnected, procedures may not be well documented, the required steps in the
process are not always completed, and employees don’t know or understand their
responsibility or authority. Points of potential noncompliance are often not identi ed,
and suppliers are not closely monitored or compelled to enforce their own quality
process improvements. Companies may neglect to do a comprehensive review of the
processes and procedures within their food safety and quality systems. Their focus is
on the food product rather than on e orts to resolve systemic issues. If a problem
occurs, these companies react quickly to nd a solution but neglect to identify the root
cause of the problem.
These operational de ciencies are key contributors to recent events. Last spring,
headlines about food contamination focused the spotlight on weaknesses within supply
chain management and the food processing industry itself.
“We recognize that we have reached a plateau in the prevention of foodborne disease,”
said Robert Tauxe, MD, MPH, deputy director of the CDC’s Division of Foodborne,
Bacterial, and Mycotic Diseases. During a brie ng in April, Dr. Tauxe called for new
farm-to-fork e orts to evaluate food safety, including improved methods to quickly
trace the source of contaminated produce.
Several months later, too many food processing companies are not yet following and
enforcing standard and consistent procedures, and they have not implemented
organization-wide trending data to predict quality and safety across all food products
and processes. Without good reporting and trending capabilities, top management at
these companies cannot make accurate assessments about the issues, risks, and costs
facing the organization.
Good quality planning, independent 3rd party gap-assessment audits, and automated
systems can address these de ciencies. The same principles of industrial automation
should be applied to best practices in quality and safety management automation with
a system-wide program that trains employees, implements well-documented standard
operating procedures (SOPs), and properly utilizes technology to put global practices
and procedures in place.
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Table 1. Applying Hazard Analysis and
Critical Control Points (HACCP) to Process
Automation
Many companies within the pharmaceutical industry, which parallels the food
processing industry in several ways, have recognized the bene ts of an integrated and
automated quality and safety platform.
Steps in the Process
Planning and Documentation: The
foundation of a successful quality and
safety management system is adequate
planning and setup. De ne code rules
and ownership, and determine the
rules and the variances to those rules.
Determine the processes and the
owners of those processes. Decide how
severity levels for issues will be de ned,
as well as who will enter the
information.
The new system must be scalable,
simple, risk-based, and easily integrated
throughout the organization. Ensure
that su cient mechanisms are in place so that all steps are completed for each event.
Determine the right people to involve in the quality and safety process and when to
involve them. Determine how procedure revisions will be handled and how these rules
and procedures should be enforced on a global level.
With good documentation standards and practices, fully automated document
management and SOP training, and an e ective enforcement system, companies can
demonstrate a commitment to food and consumer safety that will be an asset in any
future liability litigation.
Error Tracking: Many companies lack connected data sources, while others cross-
reference by hand any errors, deviations, and events across les, dates, lots, and other
criteria, a time-consuming process that often misses impacts and trends. It is an
ine cient approach that allows for repeated mistakes.
The rst step should be to identify, collect, and record information that can occur
anywhere throughout the process, including potential problems in the supply chain,
nal processing, labeling, distribution life cycle, and any potential for customer
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complaints. Being able to identify the root cause of a problem and focus on prevention
and corrective actions are key. The more information there is available, the faster the
response to a problem will be. Tracking problems allows companies to develop best
practices and verify e ectiveness.
Without an integrated system, identifying root causes is little more than guesswork.
Assumptions are made based on rumor and conjecture, not on accurate and reliable
data. Islands of information created by multiple data streams lead to inconsistencies
and waste. Genuine measuring tools enable managers to determine precisely where,
when, and why mistakes are occurring.
Auditing: Food processing companies need to have transparency about their supplier
performance across the entire organization and all products to ensure consistency,
quality control, and compliance. This means that organizations need to start focusing
on global audit programs and planning. With paper-based solutions, the approach to
global planning becomes more resource and time intensive.
Ensuring the rollout of a good audit program requires appropriate schedules for pre-
quali cation as well as for ongoing performance. But with suppliers all over the world,
limited resources for internal auditors or costly third-party auditors, and limited
availability of supplier teams, both initial and follow-up scheduling can be a nightmare.
Follow-up audits may not happen.
Automated central systems for supplier audits can provide a complete closed-loop
mechanism with checklists, schedules, ndings, actions, and follow-up, helping
standardize and streamline audit processes and cycles and ensuring that the
management and quality team are more productive and e cient. These systems mean
no document overload, as well as simpli ed and consistent reporting with complete
traceability.
Trending, Analysis, and Risk Management: Collected data should be used to help a
company detect minor problems before they become major ones, by applying risk
management techniques throughout the food safety and quality program, with
assessment of failures considered part of the overall product processing and packaging
cycle.
Many companies continue to place risk techniques at the front or back part of the
process, so that each department must individually track, trend, or analyze data.
Progressive companies, however, are proactive rather than reactive. They implement
and integrate risk techniques as part of the overall process so that the focus is on
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identifying and establishing priorities
about potential problems. Management
becomes more aware of critical
problems, and each department
identi es key areas that can improve
e cacy and food safety.
Trending is key within an organization,
helping to monitor the overall health of
a company’s safety and quality systems.
Measurement, data analysis tools, and
processes should be implemented at
di erent levels of the organization, with
linkages between processes and safety
and quality systems, and across multiple locations. Data should be con gured so that
problems related to suppliers, processes, or the quality system can be identi ed and
acted upon quickly. Leverage as much information as possible to draw targets and
assess e ectiveness. Harmonization of sources, failures, and their root causes is
essential to drawing meaningful conclusions.
HACCP and Process Automation
Re-engineering processes allows a company to get rid of all the waste and ine ciency
in its systems. Automated, simple, and intuitive procedures and robust process
architecture can result in quick navigation with a focus on problem solving rather than
navigating the maze of paper. With automated work ow (business rules engine),
noti cations, and record tracking, companies can eliminate lengthy manual steps,
streamline collaboration across the food value chain, and re ne their HACCP approach
to reduce risk and improve overall food safety. There are numerous examples of how
companies can take many of the key information system components from
International Standards Organization 22000 and see key results for HACCP from their
process automation (see Table 1).
In summary, an automated food safety management system has several bene ts:
It achieves consistent yield and uniformity from product to product and batch to
batch;
It increases traceability, data accessibility, transparency, and reporting accuracy;
It reduces supply chain risk and improves safety and quality;
It reduces the necessity of multiple audits;
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It improves cycle time for key processes: SOP approvals, changes, corrective
actions;
It reduces overhead, waste, and costs;
It ensures the food safety process is validated, veri ed, implemented, monitored,
and managed;
It increases trust along the entire production process for complete sustainability;
and
It increases awareness across the enterprise.
A great recipe is no longer enough. Today’s business climate requires continuous
process improvement and implementation of an automated and integrated safety and
quality system. A constant ow of information across the value chain can reduce the
time required to diagnose and resolve problems, can prevent supplier failures, and will
allow a company to meet consumer expectations. A well-designed and implemented
safety and quality management system can reduce risk and improve performance and
pro tability. ■
Willett is vice president of marketing and regulatory aᴀ洅airs at Pilgrim Software Inc. Reach her
at willettn@pilgrimsoftware.com or (813) 915-1663.
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haccp-can-improve-safety/