Good Manufacturing Practices (GMP) provide quality assurance guidelines for manufacturing medicines safely, effectively and consistently. GMP involves defining and documenting manufacturing processes, training personnel, validating equipment and facilities, controlling materials, documenting procedures, and inspecting to ensure compliance. Following GMP helps ensure medicines are produced and controlled according to their marketing authorization and quality standards through all stages of manufacture.
Good Manufacturing Practices (GMP) provide assurance that medicines are manufactured safely, effectively and with quality. GMP involves implementing quality management systems and following inspection guidelines to ensure compliance with standards during production. Inspections verify that manufacturing matches the authorized dossier and marketing approval. GMP guidelines cover APIs, finished pharmaceuticals, and other areas like personnel, facilities, equipment, materials, documentation, production, and quality control. Senior management plays a key role in continuously improving GMP implementation.
This document provides an overview of key quality management principles for pharmaceutical manufacturing, including quality assurance, good manufacturing practices, and quality control. It discusses the basic elements of a quality management system, including infrastructure, procedures, processes, and resources. Quality assurance aims to ensure that products satisfy requirements for quality and safety. It encompasses good manufacturing practices and involves design, development, production, and controls. Regular product quality reviews and quality risk management are important aspects of a quality assurance program.
Tony seruga yolanda seruga business expert. Tony Seruga Yolanda Seruga hates scam and fraud and any kinds of ripoff. Tony Seruga a business i con knows pros and cons and has got very good reviews as he got the best review of internet marketer.In the early years, Tony Seruga started a professional lawn service, employing college kids to do the actual work when he was only 14 years old building revenues to over $12,000 per year by the time he was 17. Tony built his first computer from a kit in 1976 and started his first “online” business in the early 1980s, using AOL and Compuserve.
Tony is a serial entrepreneur, having personally started over 240 businesses and over 600 with business partners. Tony has mentored thousands upon thousands of business owners.
Tony has been an early stage investor and entrepreneur since 1987. Tony has over two decades of experience in the venture capital, technology and entertainment industries in a multitude of investing, operational and engineering roles acting as a key adviser. In addition to his investing efforts, Tony has been active with several non-profit organizations. Tony holds a Juris Doctorate, although he never chose to practice law, opting for buying and selling businesses and investing in those projects he felt had the best chance of success.
Tony was co-owner of half a dozen early search engines including three pay-per-click search engines and was an early angel investor and adviser to four different businesses that went on to become multi-billion dollar companies. As a business adviser, Tony’s past client roster included a number of household names and celebrities.
And while Tony enjoyed speaking at business and marketing events all over the world, his real passion is to empower entrepreneurs and business owners to create massive success. Tony loves to help people to understand specifically what it takes to build a successful business. He has a very successful background in venture capital, investing and marketing. He has spent two decades working with start-ups to major global brands increasing sales, productivity and overall success and is an innovator with a remarkable ability to determine and dictate success strategies that enable companies to seize global market opportunities.
For everyone that either wishes to start their own business, currently owns a business or would like to capitalize the entrepreneurial dream, Tony’s message will enlighten them with knowledge and actionable principles to turn that passion into success. Tony has an extensive background in starting businesses, commercial real estate development and building companies around the world. Over the past two decades, he has specialized in helping companies launch, grow and create exponential valuation in the marketplace.
For more info about Tony Seruga visit http://tonyserugatonyserugatonyseruga.blogspot.com/
The document provides an overview of quality assurance (QA) from Quality Square Industry Ltd. In 3 sentences:
QA ensures that pharmaceutical products meet the quality required for their intended use by controlling all aspects that influence quality, including raw materials, equipment, personnel, manufacturing processes, and finished products. It aims to give customers assurance that they will receive products of the claimed quality. QA involves establishing procedures, conducting audits and reviews, ensuring documentation standards, and continuously improving quality.
Quality assurance and validation processes are essential for ensuring safe and effective pharmaceutical products. Key aspects of quality management include adhering to ISO, WHO, and other certification standards. Quality assurance focuses on preventing defects during development, while quality control identifies defects after production. Laboratories must follow strict safety protocols like prohibiting food/drinks, regularly disinfecting surfaces, and properly disposing of contaminated materials. Organizations should implement quality planning, control, assurance, and improvement systems.
Documentation control - principles of GMPAJAYKUMAR4872
Documentation is an essential part of QA and relates to all aspects of GMP.
The pharmaceutical industry must have a good document framework (infrastructure).
It is important for a manufacturer to get the documentation right in order to get the product right.
It is the documented act of proving that any procedure, process, equipment, material, activity or system actually leads to the expected result.
It is the confirmation by examination and the provision of objective evidence that the particular requirements for a specific intended use are fulfilled.
Q.R are planned and documented by an inspections of a review item
The review item may be a product, a group of related products or a part of a product
If the error identified earlier the cost of implication is less and the penalty for failing to conduct adequate reviews.
Good Manufacturing Practices (GMP) provide assurance that medicines are manufactured safely, effectively and with quality. GMP involves implementing quality management systems and following inspection guidelines to ensure compliance with standards during production. Inspections verify that manufacturing matches the authorized dossier and marketing approval. GMP guidelines cover APIs, finished pharmaceuticals, and other areas like personnel, facilities, equipment, materials, documentation, production, and quality control. Senior management plays a key role in continuously improving GMP implementation.
This document provides an overview of key quality management principles for pharmaceutical manufacturing, including quality assurance, good manufacturing practices, and quality control. It discusses the basic elements of a quality management system, including infrastructure, procedures, processes, and resources. Quality assurance aims to ensure that products satisfy requirements for quality and safety. It encompasses good manufacturing practices and involves design, development, production, and controls. Regular product quality reviews and quality risk management are important aspects of a quality assurance program.
Tony seruga yolanda seruga business expert. Tony Seruga Yolanda Seruga hates scam and fraud and any kinds of ripoff. Tony Seruga a business i con knows pros and cons and has got very good reviews as he got the best review of internet marketer.In the early years, Tony Seruga started a professional lawn service, employing college kids to do the actual work when he was only 14 years old building revenues to over $12,000 per year by the time he was 17. Tony built his first computer from a kit in 1976 and started his first “online” business in the early 1980s, using AOL and Compuserve.
Tony is a serial entrepreneur, having personally started over 240 businesses and over 600 with business partners. Tony has mentored thousands upon thousands of business owners.
Tony has been an early stage investor and entrepreneur since 1987. Tony has over two decades of experience in the venture capital, technology and entertainment industries in a multitude of investing, operational and engineering roles acting as a key adviser. In addition to his investing efforts, Tony has been active with several non-profit organizations. Tony holds a Juris Doctorate, although he never chose to practice law, opting for buying and selling businesses and investing in those projects he felt had the best chance of success.
Tony was co-owner of half a dozen early search engines including three pay-per-click search engines and was an early angel investor and adviser to four different businesses that went on to become multi-billion dollar companies. As a business adviser, Tony’s past client roster included a number of household names and celebrities.
And while Tony enjoyed speaking at business and marketing events all over the world, his real passion is to empower entrepreneurs and business owners to create massive success. Tony loves to help people to understand specifically what it takes to build a successful business. He has a very successful background in venture capital, investing and marketing. He has spent two decades working with start-ups to major global brands increasing sales, productivity and overall success and is an innovator with a remarkable ability to determine and dictate success strategies that enable companies to seize global market opportunities.
For everyone that either wishes to start their own business, currently owns a business or would like to capitalize the entrepreneurial dream, Tony’s message will enlighten them with knowledge and actionable principles to turn that passion into success. Tony has an extensive background in starting businesses, commercial real estate development and building companies around the world. Over the past two decades, he has specialized in helping companies launch, grow and create exponential valuation in the marketplace.
For more info about Tony Seruga visit http://tonyserugatonyserugatonyseruga.blogspot.com/
The document provides an overview of quality assurance (QA) from Quality Square Industry Ltd. In 3 sentences:
QA ensures that pharmaceutical products meet the quality required for their intended use by controlling all aspects that influence quality, including raw materials, equipment, personnel, manufacturing processes, and finished products. It aims to give customers assurance that they will receive products of the claimed quality. QA involves establishing procedures, conducting audits and reviews, ensuring documentation standards, and continuously improving quality.
Quality assurance and validation processes are essential for ensuring safe and effective pharmaceutical products. Key aspects of quality management include adhering to ISO, WHO, and other certification standards. Quality assurance focuses on preventing defects during development, while quality control identifies defects after production. Laboratories must follow strict safety protocols like prohibiting food/drinks, regularly disinfecting surfaces, and properly disposing of contaminated materials. Organizations should implement quality planning, control, assurance, and improvement systems.
Documentation control - principles of GMPAJAYKUMAR4872
Documentation is an essential part of QA and relates to all aspects of GMP.
The pharmaceutical industry must have a good document framework (infrastructure).
It is important for a manufacturer to get the documentation right in order to get the product right.
It is the documented act of proving that any procedure, process, equipment, material, activity or system actually leads to the expected result.
It is the confirmation by examination and the provision of objective evidence that the particular requirements for a specific intended use are fulfilled.
Q.R are planned and documented by an inspections of a review item
The review item may be a product, a group of related products or a part of a product
If the error identified earlier the cost of implication is less and the penalty for failing to conduct adequate reviews.
This document discusses personnel requirements and responsibilities under Good Manufacturing Practices (GMP). It outlines key principles such as having sufficient qualified personnel, defined individual responsibilities, and training programs. It describes responsibilities for key personnel like the heads of production and quality units. These include approving documentation, monitoring production and quality systems, and ensuring compliance. The document emphasizes the importance of qualified personnel for effective quality assurance and control.
This document discusses quality control and good manufacturing practices. It defines quality control and quality assurance, explaining that quality control focuses on detecting errors while quality assurance aims to prevent failures. The document then covers key aspects of good manufacturing practices, including requirements for facilities, equipment, materials, processes, packaging, labeling, documentation, and personnel. It describes the duties of various quality control roles to ensure products meet defined standards and comply with regulations. The objectives are full compliance with drug rules and GMP standards while introducing new products annually, to be measured by key performance indicators.
GMP & Quality Assurance Training by Fakultas Farmasi Universitas AndalasAtlantic Training, LLC.
GMP and quality assurance systems ensure that products are consistently manufactured and controlled according to quality standards for their intended use. QA encompasses all aspects that influence quality, including GMP and quality control. GMP specifies the production and control procedures that need to be followed. QC, as part of GMP, covers sampling, testing, and release of products to ensure the necessary tests are conducted and products meet specifications before release. Together, QA, GMP and QC work to build quality into every aspect of production from start to finish.
The document provides an overview of Good Manufacturing Practice (GMP) Auditor Training. It discusses the objectives of GMP audits, which is to plan, perform, and monitor GMP audits and identify roles and benefits. It defines GMP audits and outlines audit roles, scope, activities, documentation and principles. Key aspects covered are personnel hygiene, premises design, waste management, sanitation, and cleaning procedures.
Quality Assurance is of Tremendous Importance in Pharma and Health care sector.
A brief of that is try to explain here..
A Trust of the Customer on Product is solely based on the Effective QA
Quality assurance and good manufacturing practices are important to ensure drug quality and safety. Quality assurance covers all factors that influence a product's quality and requires adequate resources. Good manufacturing practices provide quality standards for production and controls to ensure products meet their intended use as required by regulations. Key elements of good manufacturing practices include facilities, equipment, documentation, materials management, production controls, packaging and labeling, storage, and validation. While GMPs vary between countries, the overall goals are similar in requiring design and maintenance standards, standard operating procedures, quality control, trained personnel, and management oversight.
This document provides an overview of Good Manufacturing Practices (GMPs) and how the InstantGMP software guides users through GMP compliance. It discusses GMP requirements for batch production records, master production records, materials management, and quality systems. The InstantGMP software enforces GMP workflows for purchasing, receiving, inventory management, and production. It also offers consulting services to help customers understand GMPs and transition to electronic systems.
GMP aims to ensure quality, safety and efficacy of medicines by requiring manufacturers to follow quality standards and comply with marketing authorizations. Inspections verify compliance and identify any deviations between dossiers and actual practices. Quality assurance, GMP, quality control, and quality risk management are interrelated aspects of quality management that are important for producing pharmaceuticals to the required standards.
role of quality system and audit in pharmaceutical manufacturing environment....MridulBindra2
This document discusses quality systems and audits in pharmaceutical manufacturing. It covers cGMP regulations which provide minimum standards for manufacturing drugs to ensure safety, identity, strength and quality. It describes quality assurance functions like assuring quality at every stage of manufacturing and coordinating with quality control. It also discusses the quality system approach of having management commitment to quality and establishing responsibilities. Key resources like human resources, infrastructure and work environment are also outlined.
Quality assurance is the totality of arrangements to ensure pharmaceutical products are of the required quality. It includes in-process quality checks, validation of facilities, equipment and processes, complaint handling, and stability studies. Regulatory compliance describes conforming to rules like specifications, policies, standards or laws. For pharmaceutical products, this includes complying with requirements for approvals in countries or regions like the US, Europe, and India.
The document discusses Good Manufacturing Practices (GMP) with a focus on quality control. It outlines key aspects of GMP compliance that should be reviewed during an on-site quality control laboratory inspection, including documentation, personnel qualifications, equipment and instrument validation, testing procedures, data verification, and facilities and environmental monitoring. The inspection aims to ensure proper implementation of quality standards and systems across all aspects of the quality control process.
Quality assurance & quality managmentAshok Kasetty
Quality assurance, quality control, and good manufacturing practices (GMP) are interrelated aspects of quality management in the pharmaceutical industry. Quality assurance ensures that adequate quality systems and processes are in place, quality control checks finished products, and GMP provides standards for production and controls to ensure consistent quality. Together they form a system to minimize risks and ensure that pharmaceutical products meet quality standards for patient safety.
The document discusses the role of quality assurance (QA) in the pharmaceutical industry. QA acts as key personnel to ensure customer safety, product quality, and efficacy. QA is involved throughout the product life cycle, from design and development by authorizing documents, evaluating and auditing vendors, to manufacturing through environmental monitoring, calibration, and validation. In post-production, QA oversees stability testing, sample retention, product complaints, and recalls. QA also ensures compliance through activities like change control, deviation handling, audits, and documentation. The overall goals are to build quality into products and make quality the responsibility of all involved in manufacturing.
This document outlines the process for finished product release, quality review, and batch release for pharmaceutical products. It defines a finished product and discusses who is authorized to release batches. It also describes sampling plans and techniques, testing procedures, quality review phases, and required batch release documents. Key parties involved include quality assurance, receiving and shipping, and regulatory affairs. The document provides references for further information on good manufacturing practices.
Quality Control in Pharmaceutical IndustryPrashant Tomar
Quality control is responsible for sampling, testing, and release of materials and products. It must be independent of production and have qualified staff and resources to effectively carry out quality control arrangements. Adequate facilities and approved procedures must be in place for sampling, inspecting, testing of starting materials, packaging materials, and finished products. All quality control methods, particularly testing methods, must be validated. Comprehensive records must be kept of all quality control procedures and any deviations investigated. Finished products must meet specifications for ingredients, purity, packaging, and labeling.
This document discusses quality assurance and provides definitions and explanations of key concepts. It defines quality assurance as activities that provide confidence that quality-related activities are being performed effectively. Quality can refer to technical, philosophical, practical, or metaphysical interpretations. Quality assurance is important in the pharmaceutical industry to ensure high quality standards. Quality objectives and goals help organizations improve and are identified through various inputs and analyses. An effective quality management system uses a process approach.
The document discusses Good Manufacturing Practices (GMP) and current Good Manufacturing Practices (cGMP). It defines GMP as ensuring products are consistently manufactured and controlled according to quality standards for their intended use. cGMP emphasizes that expectations are dynamic and evolve over time. The document outlines several key GMP considerations including organization and personnel qualifications, facility and equipment design, production and process control, packaging and labeling, handling and distribution, and documentation through records and reports.
This document discusses personnel requirements and responsibilities under Good Manufacturing Practices (GMP). It outlines key principles such as having sufficient qualified personnel, defined individual responsibilities, and training programs. It describes responsibilities for key personnel like the heads of production and quality units. These include approving documentation, monitoring production and quality systems, and ensuring compliance. The document emphasizes the importance of qualified personnel for effective quality assurance and control.
This document discusses quality control and good manufacturing practices. It defines quality control and quality assurance, explaining that quality control focuses on detecting errors while quality assurance aims to prevent failures. The document then covers key aspects of good manufacturing practices, including requirements for facilities, equipment, materials, processes, packaging, labeling, documentation, and personnel. It describes the duties of various quality control roles to ensure products meet defined standards and comply with regulations. The objectives are full compliance with drug rules and GMP standards while introducing new products annually, to be measured by key performance indicators.
GMP & Quality Assurance Training by Fakultas Farmasi Universitas AndalasAtlantic Training, LLC.
GMP and quality assurance systems ensure that products are consistently manufactured and controlled according to quality standards for their intended use. QA encompasses all aspects that influence quality, including GMP and quality control. GMP specifies the production and control procedures that need to be followed. QC, as part of GMP, covers sampling, testing, and release of products to ensure the necessary tests are conducted and products meet specifications before release. Together, QA, GMP and QC work to build quality into every aspect of production from start to finish.
The document provides an overview of Good Manufacturing Practice (GMP) Auditor Training. It discusses the objectives of GMP audits, which is to plan, perform, and monitor GMP audits and identify roles and benefits. It defines GMP audits and outlines audit roles, scope, activities, documentation and principles. Key aspects covered are personnel hygiene, premises design, waste management, sanitation, and cleaning procedures.
Quality Assurance is of Tremendous Importance in Pharma and Health care sector.
A brief of that is try to explain here..
A Trust of the Customer on Product is solely based on the Effective QA
Quality assurance and good manufacturing practices are important to ensure drug quality and safety. Quality assurance covers all factors that influence a product's quality and requires adequate resources. Good manufacturing practices provide quality standards for production and controls to ensure products meet their intended use as required by regulations. Key elements of good manufacturing practices include facilities, equipment, documentation, materials management, production controls, packaging and labeling, storage, and validation. While GMPs vary between countries, the overall goals are similar in requiring design and maintenance standards, standard operating procedures, quality control, trained personnel, and management oversight.
This document provides an overview of Good Manufacturing Practices (GMPs) and how the InstantGMP software guides users through GMP compliance. It discusses GMP requirements for batch production records, master production records, materials management, and quality systems. The InstantGMP software enforces GMP workflows for purchasing, receiving, inventory management, and production. It also offers consulting services to help customers understand GMPs and transition to electronic systems.
GMP aims to ensure quality, safety and efficacy of medicines by requiring manufacturers to follow quality standards and comply with marketing authorizations. Inspections verify compliance and identify any deviations between dossiers and actual practices. Quality assurance, GMP, quality control, and quality risk management are interrelated aspects of quality management that are important for producing pharmaceuticals to the required standards.
role of quality system and audit in pharmaceutical manufacturing environment....MridulBindra2
This document discusses quality systems and audits in pharmaceutical manufacturing. It covers cGMP regulations which provide minimum standards for manufacturing drugs to ensure safety, identity, strength and quality. It describes quality assurance functions like assuring quality at every stage of manufacturing and coordinating with quality control. It also discusses the quality system approach of having management commitment to quality and establishing responsibilities. Key resources like human resources, infrastructure and work environment are also outlined.
Quality assurance is the totality of arrangements to ensure pharmaceutical products are of the required quality. It includes in-process quality checks, validation of facilities, equipment and processes, complaint handling, and stability studies. Regulatory compliance describes conforming to rules like specifications, policies, standards or laws. For pharmaceutical products, this includes complying with requirements for approvals in countries or regions like the US, Europe, and India.
The document discusses Good Manufacturing Practices (GMP) with a focus on quality control. It outlines key aspects of GMP compliance that should be reviewed during an on-site quality control laboratory inspection, including documentation, personnel qualifications, equipment and instrument validation, testing procedures, data verification, and facilities and environmental monitoring. The inspection aims to ensure proper implementation of quality standards and systems across all aspects of the quality control process.
Quality assurance & quality managmentAshok Kasetty
Quality assurance, quality control, and good manufacturing practices (GMP) are interrelated aspects of quality management in the pharmaceutical industry. Quality assurance ensures that adequate quality systems and processes are in place, quality control checks finished products, and GMP provides standards for production and controls to ensure consistent quality. Together they form a system to minimize risks and ensure that pharmaceutical products meet quality standards for patient safety.
The document discusses the role of quality assurance (QA) in the pharmaceutical industry. QA acts as key personnel to ensure customer safety, product quality, and efficacy. QA is involved throughout the product life cycle, from design and development by authorizing documents, evaluating and auditing vendors, to manufacturing through environmental monitoring, calibration, and validation. In post-production, QA oversees stability testing, sample retention, product complaints, and recalls. QA also ensures compliance through activities like change control, deviation handling, audits, and documentation. The overall goals are to build quality into products and make quality the responsibility of all involved in manufacturing.
This document outlines the process for finished product release, quality review, and batch release for pharmaceutical products. It defines a finished product and discusses who is authorized to release batches. It also describes sampling plans and techniques, testing procedures, quality review phases, and required batch release documents. Key parties involved include quality assurance, receiving and shipping, and regulatory affairs. The document provides references for further information on good manufacturing practices.
Quality Control in Pharmaceutical IndustryPrashant Tomar
Quality control is responsible for sampling, testing, and release of materials and products. It must be independent of production and have qualified staff and resources to effectively carry out quality control arrangements. Adequate facilities and approved procedures must be in place for sampling, inspecting, testing of starting materials, packaging materials, and finished products. All quality control methods, particularly testing methods, must be validated. Comprehensive records must be kept of all quality control procedures and any deviations investigated. Finished products must meet specifications for ingredients, purity, packaging, and labeling.
This document discusses quality assurance and provides definitions and explanations of key concepts. It defines quality assurance as activities that provide confidence that quality-related activities are being performed effectively. Quality can refer to technical, philosophical, practical, or metaphysical interpretations. Quality assurance is important in the pharmaceutical industry to ensure high quality standards. Quality objectives and goals help organizations improve and are identified through various inputs and analyses. An effective quality management system uses a process approach.
The document discusses Good Manufacturing Practices (GMP) and current Good Manufacturing Practices (cGMP). It defines GMP as ensuring products are consistently manufactured and controlled according to quality standards for their intended use. cGMP emphasizes that expectations are dynamic and evolve over time. The document outlines several key GMP considerations including organization and personnel qualifications, facility and equipment design, production and process control, packaging and labeling, handling and distribution, and documentation through records and reports.
This document provides an overview of good manufacturing practices (GMP) in the pharmaceutical industry. It begins with definitions of GMP and discusses its early history starting in the 1900s with no regulations. Key events that led to increased regulation include Upton Sinclair's 1905 book The Jungle exposing unsanitary meat plants and the 1906 Pure Food and Drug Act. The document then outlines the timeline of major GMP regulations from 1902 to the present. It provides details on key areas covered by GMP including personnel, premises, equipment, process validation, and quality assurance.
The document outlines the key aspects of current good manufacturing practices (cGMPs) that pharmaceutical manufacturers must follow. cGMPs come from the Food, Drug and Cosmetic Act and are enforced by the FDA. They help ensure safety and quality by requiring strict control over facilities, equipment, components, packaging, labeling, and processes. Key parts of cGMP regulations address organization, buildings, equipment, materials control, production, packaging, holding, distribution, and records. Failure to comply can result in serious legal and business consequences like product recalls or plant shutdowns.
The document describes an industry program in pharmaceutical quality assurance and quality control offered through distance learning. The 12-month program aims to enhance knowledge of quality professionals and provide in-depth training in areas like GMP, quality assurance, regulation, and statistics. It covers 7 modules and career prospects in quality assurance, control, auditing, and management are discussed. The program awards a certificate upon completion.
This document is a proposal for an M.E. thesis on studying and analyzing product quality control. The proposal outlines introducing quality and quality control, aims of quality control like improvement and reduction of costs, the scope focusing on materials selection and quality control methods, an implementation plan to study theory and do case studies, and expected outcomes of improving product quality, productivity, and reducing costs.
Here are the key points about scope management:
- Scope management involves defining and controlling what work needs to be done to deliver the project objectives and meet stakeholder requirements. It aims to identify all required work, and only the work required, to complete the project successfully.
- The main scope management processes are collect requirements, define scope, create WBS, verify scope, and control scope.
- Collect requirements involves gathering stakeholder needs and documenting them as the project requirements. This forms the basis for all subsequent planning.
- Define scope develops a detailed description of the project and deliverables based on the requirements.
- Create WBS breaks the project deliverables and work down into smaller, more manageable components in
This document provides an introduction and overview of Good Manufacturing Practices (GMPs). It discusses the history and importance of GMPs in ensuring drug safety. GMPs are regulations followed by pharmaceutical companies and enforced by government agencies to ensure consistency and quality in manufacturing. The document outlines the key aspects of GMPs, including requirements for facilities, equipment, personnel, sanitation, materials testing, manufacturing controls, quality control, documentation, and specific rules for sterile products.
This document discusses quality control procedures for evaluating a project. It outlines several ways to assess quality, including submitting progress reports, conducting pre-and post-tests, providing a warranty, and acknowledging limitations. Quality control focuses on controlling elements of production, ensuring competence, and addressing soft elements like culture. It emphasizes testing products for defects and reporting issues to management.
This document discusses Good Manufacturing Practice (GMP) in the pharmaceutical industry. It provides the history and regulations around GMP, explains why following GMP is important, and outlines the key elements that make up a GMP system.
GMP guidelines were established in the 1960s after thousands of babies were born with birth defects due to the drug Thalidomide. Regulations were put in place to ensure drug safety and quality. Following GMP helps build quality into manufacturing processes and products to avoid mistakes that could harm patients. Key aspects of GMP include controlling quality, using well-trained staff, thorough documentation, and adequate premises and equipment. The overall goal is to establish a system that consistently produces high quality pharmaceutical products.
The document outlines good manufacturing practices (GMP) that must be followed to produce safe products. It discusses personnel hygiene practices, facility requirements, storage practices, process equipment guidelines, cleaning and sanitation procedures, pest control measures, and documentation standards that are necessary to ensure product quality and safety.
Good Manufacturing Practice (“GMP”) Compliance: GMPs EXPLAINED by SIDLEY AUST...Atlantic Training, LLC.
The document outlines Good Manufacturing Practices (GMP) that must be followed in the pharmaceutical industry to ensure safety, identity, strength, quality, and purity of drugs. It discusses GMP requirements for facilities, equipment, production, packaging, labeling, quality control, auditing and more. Failure to comply with GMPs can result in severe consequences for companies such as product seizures, recalls, injunctions and criminal penalties. The document was presented at a pharmaceutical regulatory conference to explain GMP compliance.
Quality control is a process used to ensure a certain level of quality in products or services. It involves examining and testing products or services to ensure they meet requirements for being dependable, satisfactory, safe, and financially sound. Quality control can occur at different stages, such as when raw materials are received, during production, or after a product is finished. Some common quality control methods include check sheets, control charts, histograms, Ishikawa diagrams, Pareto charts, scatter diagrams, and flow charts. Problems with quality control include that it does not add value, is costly, and is sometimes done too late or by the wrong people. Quality assurance focuses on examining the production process to reduce quality issues, while quality control examines the final
Quality refers to the characteristics of a product that satisfy customer needs. Quality control aims to ensure economical production of uniform, dependable products that meet customer expectations. It involves establishing quality standards and monitoring production to identify and address defects. Common quality control techniques include just-in-time production, quality at the source, inspection, statistical process control, quality circles, and total quality management. The overall goal is to prevent defects and continuously improve processes and customer satisfaction.
The document discusses quality assurance and control. It emphasizes the importance of quality assurance and control in improving customer satisfaction and conforming to specifications. It outlines several key aspects of quality assurance including quality planning, assurance, and control. It also discusses how to integrate quality assurance with customer satisfaction and conformance to requirements.
The document discusses Good Manufacturing Practices (GMP) and contamination prevention. It covers types of contamination, sources, and how to prevent them through practices like personal hygiene, sanitation, cleaning, and equipment maintenance. GMP regulations require facilities, equipment, personnel training, and documentation to help assure product quality and safety.
Quality assurance aims to ensure that pharmaceutical products meet quality standards by building quality into every stage of design, development, and manufacturing. It involves planned and documented activities like process validation, quality audits, and staff training to verify that products satisfy quality requirements. Quality control is the part of GMP concerned with testing and release of materials and products to ensure they meet specifications before release or use. Together, quality assurance and quality control comprise a quality system that helps deliver pharmaceuticals free of contamination and suitable for their intended use.
Quality control involves sampling, testing, and ensuring products meet specifications before release. It is focused on identifying defects in finished products. Key responsibilities include testing raw materials, conducting in-process testing, and approving or rejecting starting materials, packaging, intermediates, and finished products. Quality control aims to fulfill quality requirements and ensure only products passing tests are released.
1. The document discusses the key differences between quality assurance (QA) and quality control (QC). QA focuses on processes and aims to prevent defects, while QC focuses on products and aims to identify defects.
2. It also provides an overview of Good Manufacturing Practices (GMP), which ensure products are consistently produced according to quality standards. GMP covers all aspects of production from materials to equipment to personnel.
3. The main GMP principles are that manufacturing processes are clearly defined and validated, adequate resources are provided, instructions are written clearly, procedures are followed correctly, and comprehensive records are kept.
Good Laboratory Practice (GLP) guidelines provide standards for laboratory experiments and tests performed to support research, nonclinical studies, and regulatory submissions. The key goals of GLP are to ensure quality, reliability, and integrity of data through adherence to standard operating procedures, trained personnel, appropriate facilities and equipment, records management, and quality control. GLP aims to promote valid and robust research that can be reproduced internationally and supports regulatory review and decision making.
2-Quality-assurance-6th-Sem Quality control and GMPVenkatesh Mantha
The document defines key concepts in quality assurance, quality control, and good manufacturing practices (GMP) for pharmaceuticals. It discusses that quality assurance is a process-oriented approach to ensuring quality, while quality control is a product-oriented approach focused on identifying defects. GMP involves all aspects of pharmaceutical production to minimize risks and ensure quality, safety, and efficacy. It outlines responsibilities for quality control, production, and procedures to verify that medicines meet specifications from raw materials to patient use.
This document provides an overview of key quality assurance and quality management concepts including quality management systems, quality assurance, quality control, and good manufacturing practices (GMP). It defines these terms and describes their purposes and responsibilities. A quality management system consists of quality planning, assurance, control, and improvement to ensure products meet requirements. Quality assurance focuses on preventing defects, quality control identifies defects, and GMP provides minimum standards for pharmaceutical production and quality.
1. GMP aims to ensure quality, safety and efficacy of pharmaceutical products through proper manufacturing and quality control.
2. Key aspects of GMP include facilities and equipment design, sanitation, personnel training, validation processes, documentation systems, and quality control testing.
3. Adhering to GMP guidelines helps manufacturers consistently produce pharmaceuticals that meet specifications and protects patients from defective products.
WHO inspections of manufacturing facilities and contract research organizations follow standardized procedures to evaluate compliance with Good Manufacturing Practices and Good Clinical Practices. Inspections are conducted by teams and include reviewing documentation, processes, and data. Common observations include incomplete validation, deficient quality systems, and unreliable data. The number of inspections has increased annually across different types of facilities from 2005 to 2009.
Quality assurance and quality control are important concepts in pharmaceutical manufacturing. Quality assurance refers to planned and systematic activities that ensure quality in processes, while quality control refers to activities that ensure quality in products. Some key differences are that quality assurance focuses on preventing defects through proper processes, while quality control identifies defects in finished products. Total quality management aims to produce perfect products through quality measures at every stage of production and requires team effort across an organization.
Gmp (q7 ich guide) & Stem cells-based therapy product manufacturingM. Agung Sumantri
This document provides a summary of key points from the ICH Q7 guideline on good manufacturing practices for active pharmaceutical ingredients:
- It establishes quality management principles for ensuring APIs meet intended specifications, including defining organizational structures, procedures, processes, and responsibilities.
- Manufacturing operations of APIs and intermediates should be clearly defined and documented. Any deviations must be documented and investigated.
- An independent quality unit is responsible for approving or rejecting APIs, materials, equipment, processes, and review of production records, audits and product quality reviews.
- Personnel involved in manufacturing APIs must be qualified and trained. Hygiene practices and facilities must allow for clean and orderly manufacturing operations.
In a welcome move, the Pharmacy Council of India has recently re-structured the syllabus of the
Bachelor of Pharmacy course. In the effort to make the content more relevant to the practice of
pharmacy in its current form, we now find new, important subjects introduced, and Pharmaceutical
Quality Assurance is one of them.
good manufacturing practices presentationUltratech4
This document discusses Good Manufacturing Practices (GMP) and Standard Operating Procedures (SOPs). It defines GMP as ensuring quality standards in drug production and outlines its main principles, including organization, facilities, equipment, materials control, production processes, packaging, and records. SOPs are defined as written instructions for routine tasks and the document discusses benefits like consistent performance, quality assurance, and training. A typical SOP structure is also outlined.
This document discusses concepts related to quality management and quality control in the pharmaceutical industry. It defines key terms like total quality management, quality assurance, and good manufacturing practices. It explains that quality should be built into products from the beginning of the production process through materials procurement, manufacturing, distribution, and obtaining customer feedback. It also outlines the objectives, systems, and components of quality management systems, including quality planning, risk management, corrective actions, and change control. Quality control is described as the system for ensuring proper testing and release of materials and products.
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This document provides an overview of Good Manufacturing Practices (GMP) for pharmaceutical manufacturing. It defines GMP as ensuring products are consistently manufactured and controlled to quality standards for their intended use. The document outlines key aspects of GMP, including facilities and equipment qualification, training, documentation, production and process controls, packaging and labeling, quality testing, and distribution. It explains that GMP is important for producing safe, effective drugs and minimizing risks that cannot be detected through final testing alone. International GMP guidelines from organizations like WHO, FDA, and ICH are also referenced.
Good laboratory practices in a pharmaceutical lab 1Sabahat Ali
This document discusses good laboratory practices in a pharmaceutical lab. It outlines the members of a group project on this topic and provides an introduction to pharmaceutical lab testing. It then covers topics like GMP, GLP, quality control, quality assurance, reducing human errors, and the scope of QA and QC in a pharmaceutical lab. Key points include that pharmaceutical labs test raw materials, finished products, and conduct validation, stability, and analytical method development testing. GMP and GLP aim to minimize risks and ensure consistent quality production. QA and QC work to guarantee drug quality and safety at all stages from development to sales.
1. QUALITY ASSURANCE AND QUALITY MANAGEMENT CONCEPTS.pptxPratikTerse3
This document discusses concepts related to quality assurance and quality management. It defines quality, quality assurance, and quality control. Quality assurance aims to provide confidence that products will meet requirements, while quality control tests products to ensure they meet specifications. The key difference is that quality assurance focuses on preventing defects through processes, while quality control identifies defects through testing. Good manufacturing practices and regulatory bodies that ensure quality are also outlined.
This document provides an overview of quality management systems, including quality assurance, quality control, and good manufacturing practices (GMP). It defines quality management as determining and implementing quality policy through an organizational structure with procedures, processes, and resources. Quality assurance aims to maximize the probability of continuously producing high quality products through policies, standards, and quality checks of materials and services. Quality control refers to measuring products against standards and rectifying any differences found. Both quality assurance and quality control follow SOPs and GMP regulations to ensure pure, effective, safe products. GMP guidelines provide assurance of identity, quality, and strength of pharmaceuticals through correct manufacturing procedures.
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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.
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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.
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2. 2 | PQ Workshop, Abu Dhabi | October 2010
Why GMP?
Provides a high level assurance that medicines
are manufactured in a way that ensures their
safety, efficacy and quality
Medicines are manufactured to comply with their
marketing authorization
Quality is built in
– Testing is part of GMP, but alone does not provide a
good level of quality assurance
3. 3 | PQ Workshop, Abu Dhabi | October 2010
Why inspect?
Verify compliance with GMP
Verify compliance with marketing authorization
– Dossier: "Dedicated equipment is used"
Inspection: Observation that this means "dedicated while used
for the product or not being used for another product"
– Dossier: "The vials are removed from the lyophilliser and
crimped in a grade A environment"
Inspection: Correct, but before crimping they are stored in an
uncontrolled corridor
4. 4 | PQ Workshop, Abu Dhabi | October 2010
WHO GMP
Quality assurance of pharmaceuticals
A compendium of guidelines and related materials
Volume 2, 2nd updated edition
Good manufacturing practices
and inspection
5. 5 | PQ Workshop, Abu Dhabi | October 2010
Guidelines and references
GMP applies to both Active Pharmaceutical
Ingredients (APIs) and Finished Pharmaceutical
Products (FPPs)
– FPP:
WHO Good Manufacturing Practices for pharmaceutical
products: main principles. WHO Technical Report
Series, No. 908, 2003, Annex 4.
– API:
WHO good manufacturing practices for active
pharmaceutical ingredients - Annex 2, WHO
Technical Report Series 957, 2010 (Based on ICH
Q7)5
6. 6 | PQ Workshop, Abu Dhabi | October 2010
Other WHO GMP Guidelines
Pharmaceutical excipients
Sterile pharmaceutical products
Biological products
Pharmaceutical products containing hazardous
substances
Investigational pharmaceutical products for clinical trials i
Herbal medicinal products
Radiopharmaceutical products
Water for pharmaceutical use
HVAC for non-sterile pharmaceutical dosage forms
Validation
7. 7 | PQ Workshop, Abu Dhabi | October 2010
Good Manufacturing Practices:
1. Quality assurance
2. Good manufacturing practices for pharmaceutical
products
3. Sanitation and hygiene
4. Qualification and validation
5. Complaints
6. Product recalls
7. Contract production and analysis
– General
– The contract giver
– The contract accepter
– The contract
8. 8 | PQ Workshop, Abu Dhabi | October 2010
Good Manufacturing Practices (cont'd)
8. Self-inspection and quality audits
– Items for self-inspection
– Self-inspection team
– Frequency of self-inspection
– Self-inspection report
– Follow-up action
– Quality audit
– Suppliers’ audits and approval
9. Personnel
– General
– Key personnel
10. Training
9. 9 | PQ Workshop, Abu Dhabi | October 2010
Good Manufacturing Practices (cont'd)
11. Personal hygiene
12. Premises
– General
– Ancillary areas
– Storage areas
– Weighing areas
– Production areas
– Quality control area
13. Equipment
10. 10 | PQ Workshop, Abu Dhabi | October 2010
Good Manufacturing Practices (cont'd)
14. Materials
– General
– Starting materials
– Packaging materials
– Intermediate and bulk products
– Finished products
– Rejected, recovered, reprocessed and reworked materials
– Recalled products
– Returned goods
– Reagents and culture media
– Reference standards
– Waste materials
– Miscellaneous
11. 11 | PQ Workshop, Abu Dhabi | October 2010
Good Manufacturing Practices (cont'd)
15. Documentation
– General
– Documents required:
• Labels
• Testing procedures
• Specifications for starting and packaging materials, for
intermediate and bulk products and for finished products
• Master formulae and Batch Processing Records
• Packaging instructions and Batch Packaging Records
• Standard Operating procedures (SOP's) and records
• Logbooks
12. 12 | PQ Workshop, Abu Dhabi | October 2010
Good Manufacturing Practices (cont'd)
16. Good practices in production
– General
– Prevention of cross-contamination and bacterial
contamination during production
– Processing operations
– Packaging operations
17. Good practices in quality control
– Control of starting materials and intermediate, bulk and
finished products
– Test requirements
– Batch record review
– Stability studies
13. 13 | PQ Workshop, Abu Dhabi | October 2010
GMP is actually Good Common Sense
Quality Management
Quality Assurance
GMP
Production and Quality Control
Section 1 and 2
14. 14 | PQ Workshop, Abu Dhabi | October 2010
Quality management in the drug industry
Philosophy and essential elements:
"The concepts of quality assurance, GMP, quality
control and quality risk management are
interrelated aspects of quality management, and
should be the responsibility of all personnel. ……
their relationship and their fundamental
importance to the production and control of
pharmaceutical products."
Glossary
15. 15 | PQ Workshop, Abu Dhabi | October 2010
Quality Management
The basic elements are:
– An appropriate infrastructure or “quality system”
encompassing the organization structure,
procedures, processes and resources
– The systematic actions necessary to ensure adequate
confidence that a product (or service) will satisfy given
requirements for “Quality”
The totality of these actions is referred to as “Quality
Assurance”
16. 16 | PQ Workshop, Abu Dhabi | October 2010
The five P's
Premises
Primary materials
People
Processes defined and recorded
17. 17 | PQ Workshop, Abu Dhabi | October 2010
Quality Assurance
Quality assurance is a management tool
In contractual situations, it also serves to generate
confidence in a supplier
QA, GMP and Quality Control are interrelated aspects
of Quality Management
– They are described on the following slides in order to
emphasize their relationship and their fundamental
importance to the production and control of
pharmaceutical products 1.1
18. 18 | PQ Workshop, Abu Dhabi | October 2010
Quality Assurance
Wide-ranging concept
– covers all matters that individually or collectively
influence the quality of a product
Totality of the arrangements
– to ensure that the drug is continuously of the right
quality for the intended use
Quality Assurance incorporates GMP
– and also includes product design and
development, with special focus on process
design 1.1
19. 19 | PQ Workshop, Abu Dhabi | October 2010
The position of QA
DirectorDirector
QAQA
ProductionProduction QC labQC lab Other DeptsOther Depts
20. 20 | PQ Workshop, Abu Dhabi | October 2010
Quality Assurance means to assure:
Products are designed and developed correctly
– Complying with, e.g. GMP, GCP, GLP
Production and control operations are defined
Managerial responsibilities are defined
– In job descriptions
The manufacture, supply and use of correct starting
and packaging materials 1.1 a- d
21. 21 | PQ Workshop, Abu Dhabi | October 2010
Quality Assurance means to assure:
(cont'd)
Controls are performed, including
intermediates, bulk, calibration and validation
Correct processing and checking of the
finished product
Products are sold/supplied only after review
by the authorized person
– Complying with marketing authorization,
production and QC requirements
Proper storage, distribution and handling
1.1 e - h
22. 22 | PQ Workshop, Abu Dhabi | October 2010
Quality Assurance means to assure:
(cont'd)
Procedures for self-inspection and quality
audits are applied
Deviations are reported, investigated and
recorded
System for change control is applied
Regular evaluation of product quality to
verify consistency and continued
improvement
1.1 i - l
23. 23 | PQ Workshop, Abu Dhabi | October 2010
Quality Assurance includes:
Responsibility of the Manufacturer for the quality of the
product
– Fit for intended use
– Comply with marketing authorization
– Safety, efficacy and quality
Commitment of senior management and involvement of all
staff
Comprehensively designed and well implemented quality
system
Full documentation and monitoring of effectiveness
Competent personnel, sufficient premises, equipment and
facilities 1.3
24. 24 | PQ Workshop, Abu Dhabi | October 2010
Good Manufacturing Practices
That part of QA that ensures that products are
consistently produced and controlled
– Quality standards
– Marketing authorization
Aim: Diminishing risks that cannot be controlled
by testing of product
– Contamination and cross-contamination
– Mix-ups (confusion) 2.1
25. 25 | PQ Workshop, Abu Dhabi | October 2010
Basic requirements for GMP:
Clearly defined and systematically reviewed
processes
Qualification and validation is performed
Appropriate resources are provided:
– Qualified and trained personnel
– Premises, space, equipment and services
– Materials, containers, labels
– Procedures, storage, transport
– Laboratories and in-process control
2.1 a - c
26. 26 | PQ Workshop, Abu Dhabi | October 2010
Basic requirements for GMP: (cont'd)
Clear, written instructions and procedures
Trained operators
Records of actions, deviations and
investigations
Records for manufacture and distribution
Proper storage and distribution
Systems for complaints and recalls 2.1 d - j
27. 27 | PQ Workshop, Abu Dhabi | October 2010
GMP = continuous urge for improvement
Involvement of the management
Annual Product Quality Review
Quality risk management
Complaints handling
Self-inspection
28. 28 | PQ Workshop, Abu Dhabi | October 2010
Involvement of the management
The senior management is responsible to attain the
company's quality objectives
All different departments and all levels within
departments should be involved; and it's the senior
management who should facilitate this
Also suppliers and distributors should be involved
The senior management should make available the
required resources
The basis of the quality system is the quality statement
and quality policy, by the senior management
29. 29 | PQ Workshop, Abu Dhabi | October 2010
Product Quality Review
Objectives of Product Quality Review:
To review and verify the consistency and
appropriateness of the existing process
To identify and highlight any trends in the
process, e.g. in analytical results, yields etc.
To identify any possible product or process
improvements
30. 30 | PQ Workshop, Abu Dhabi | October 2010
Product Quality Review (cont'd)
Review of starting materials/ packaging
materials, especially from new sources
Review of in-process control results and finished
product analytical control results
Amount of batches and packaging units
produced and their yields
Reviews of:
– Out-of-spec situations, rejections, deviations, changes
– Plus investigations and analysis of causes
31. 31 | PQ Workshop, Abu Dhabi | October 2010
Annual Product Quality Review (cont'd)
Review of Marketing Authorization variations
submitted, granted or refused (incl. third countries)
Review of stability programme and trends
Review of adequacy of previous decisions on
changes or improvements or corrective actions
For new Marketing Authorizations (plus new
variations) a review of post marketing commitment
The qualification status of all relevant equipment
and utilities (like water, HVAC, gases, etc.)
Review of Technical Agreements (if applicable)
32. 32 | PQ Workshop, Abu Dhabi | October 2010
5.1
Complaints handling
Complaints: Principle
“All complaints and other information
concerning potentially defective products
must be carefully reviewed according to
written procedures and corrective action
should be taken.”
33. 33 | PQ Workshop, Abu Dhabi | October 2010
5.2 – 5.3
Complaints Procedure
Designated responsible person:
– To handle complaint
– Decide on measure to be taken
– May be authorized person - if not, must advise
authorized person of results
– Sufficient support staff
– Access to records
Written procedure (SOP):
– Describes action to be taken
– Includes need to consider a recall (e.g. possible
product defect)
34. 34 | PQ Workshop, Abu Dhabi | October 2010
5.4 – 5.6
Complaints Procedure – cont'd
Thorough investigation:
– QC involved
– With special attention to establish whether
"counterfeiting" may have been the cause
– Fully recorded investigation – reflect all the details
Due to product defect (discovered or suspected):
– Consider checking other batches
– Batches containing reprocessed product
35. 35 | PQ Workshop, Abu Dhabi | October 2010
5.7 – 5.9
Complaints Procedure – cont'd
Investigation and evaluation should result in
appropriate follow-up actions
– May include a "recall"
All decisions and measures taken should be
recorded
Referenced in batch records
Records reviewed - trends and recurring problems
36. 36 | PQ Workshop, Abu Dhabi | October 2010
5.10
Complaints - other actions
Inform competent authorities in case of serious
quality problems such as:
– Faulty manufacture
– Product deterioration
– Counterfeiting
Have a thorough recall procedure that is consistent
with the complaints handling procedure
Trend complaints, their investigations and results
37. 37 | PQ Workshop, Abu Dhabi | October 2010
Self-Inspection
Purpose is to evaluate whether a company’s
operations remain compliant with GMP
The programme should
– cover all aspects of production and quality control
– be designed to detect shortcomings in the implementation of
GMP
– recommend corrective actions
– set a timetable for corrective action to be completed
Should be performed routinely
Also on special occasions such as
– Recalls
– Repeated rejections 8.1
38. 38 | PQ Workshop, Abu Dhabi | October 2010
8.3, 8.4
Self-Inspection (cont'd)
Performed by team appointed by management, with:
– authority
– sufficient experience, expertise in their own field.
knowledge of GMP
– may be from inside or outside the company
Frequency should normally be at least once a year
– May depend on company requirements
– Size of the company and activities
39. 39 | PQ Workshop, Abu Dhabi | October 2010
8.5, 8.6
Self-Inspection (cont'd)
Report prepared at completion of inspection,
including:
– results
– evaluation
– conclusions
– recommended corrective measures
Follow-up action
– Effective follow-up programme
– Company management to evaluate both
the report and corrective actions
40. 40 | PQ Workshop, Abu Dhabi | October 2010
Summary and conclusions:
GMP compliance is not an option
Quality should be built into the product
GMP's are very similar and are really
Good Common Sense
Good Practices cover all aspects of
manufacturing activities prior to supply
The role and involvement of senior
management is crucial
41. 41 | PQ Workshop, Abu Dhabi | October 2010
http://www.who.int/prequal
41
Editor's Notes
The product complaint principle is defined in the WHO GMP.
The manufacturer must assume responsibility for the quality of the pharmaceutical products to ensure that they are fit for their intended use, comply with the requirements of the marketing authorization, and do not place the patient at risk because of inadequate safety, quality or efficacy.
Complaints must be handled positively and carefully reviewed, and corrective actions must be taken as necessary. This can mean amending a manufacturing process as well as implementing a recall of a defective product from all markets where it has been distributed.
First of all a written complaints handling procedure should be available.
The basic requirements for such a procedure are:
A designated person must be appointed with authority to conduct complaints reviews in accordance with the SOPs. The person designated may be the authorized person responsible for quality control. If not, then that QC person must be kept informed of all complaints being investigated. The designated person must have sufficient staff to be able to review all the complaints received in an effective and rapid manner. They must to be able to access all the relevant records concerning the product under discussion.
Required actions are described.
The complaint is acknowledged and a response to the customer is provided.
Written and verbal comments are recorded.
The QC department should be involved throughout the investigation. The investigation should be thorough and fully recorded– and reflect all the details of the investigation in the records.
Special attention must be given to try and establish whether "counterfeiting" may have been the cause.
If there is a product defect (discovered or suspected), then the company should consider checking other batches, and may have to check batches containing reprocessed product.
Investigation and evaluation should result in appropriate follow up actions taken. This may include a "recall" of the product, or batch.
All decisions and measures taken should be recorded.
The complaint should also be referenced in batch records – and may thus help during the review or annual product review, trend analysis etc.
Complaint records should be reviewed on a regular basis as defined in the SOP. Trends and recurring problems should be identified and proper action taken to prevent recurrence of the problem/cause. As complaints are investigated and records are built up, then trends may start to become clear. A regular review of complaint records to establish whether there is a trend for a particular product, dosage form, customer, distribution channel or similar should be undertaken. This is where the true value of a good complaints handling procedure shows. It may be that a particular formulation or particular machine is giving rise to complaints. This trend analysis process is an opportunity for continuous improvement.
It may be that a particular customer is engaged in fraudulent behaviour.
The competent authority must be informed of any serious quality problems that are revealed by the complaint investigation
The purpose of self-inspection is to evaluate the manufacturer’s compliance with GMP in all aspects of production and quality control.
It also assists in ensuring quality improvement. There should be a programme that covers all aspects of production and quality control. It should be designed to detect shortcomings in the implementation of GMP and recommend corrective actions. The company should set a timetable for corrective action to be completed. You can verify this during your assessment.
The self-inspection team is appointed by the management of the company and is made up of a mixture of people, including experts in GMP and persons familiar with the area to be inspected. It is useful to have people from production, QC and engineering on the team, as they will bring different perspectives to the inspection.
The team leader needs to be someone who has access to the resources to produce a report at the end of the process, and with the authority and experience to organize and manage a team activity. Hence it is usually, but not always, a manager or supervisor.
The leader should be from a different department so that he/she can take a more impartial viewpoint.
It is important that the team members are encouraged to be objective in their evaluation.
The frequency with which self-inspections are carried out will depend on the company. For a small company that can cover all its operations in one inspection, a three or six-monthly review might be sufficient. However, for a larger company that needs to split the inspection into a number of sections, a programme of monthly inspections covering the whole factory in three to six months might be more appropriate.
All inspections need reports as an outcome; otherwise there is no formal record of the findings and recommendations.
This report should be issued as quickly as possible while things are fresh in people’s minds. It does not need to be an elaborate, wordy document that no one will read. A simple list of findings with recommendations for corrective action is sufficient. However, it is important that responsibility for action and a time frame are agreed, either during the inspection or soon after the report is issued.
A self-inspection without follow-up is unlikely to be particularly effective and it is important that the company management ensures that the corrective measures are carried out to the agreed timetable.