This document discusses quality assurance and regulatory compliance for pharmaceutical products. It defines key terms like quality assurance, quality control, and good manufacturing practices. It explains that quality assurance involves organizing all aspects of production to ensure products meet the required quality standards for their intended use. This includes following good manufacturing practices and quality control procedures during development, manufacturing, and distribution to maintain quality. The document also outlines the quality assurance system, including validation, documentation control, quality monitoring, and continuous improvement.
Quality Assurance and Regulatory Compliance for Pharmaceutical Product, Prof. Dr. Basavaraj K. Nanjwade, KLE University College of Pharmacy, Belgaum/Belagavi
As you know, pharma compliance is a critical issue, particularly in China. The Chinese government’s recent crackdowns on the business practices of various pharmaceutical companies have sent shockwaves throughout the industry and the price to pay for non-compliance is exceedingly high, with massive revenue losses and irreclaimable reputational damages
To address this pertinent issue, IBC Asia is convening the forthcoming Pharma Compliance Summit
(Mar 2015) in Shanghai, China. Set to be an informative and insightful event, this conference will prepare participants in dealing with the latest legal compliance landmines and equip them with an in-depth understanding of how to mitigate non- compliance risks at every part of the pharma value chain.
Top companies will share best practices of internal compliance programs and third party due diligence strategies; Gain these exclusive insights and incorporate them into their own company, reaping maximum benefits.
Your expert speaker faculty includes:
• Leon Wang, Vice President, AstraZeneca China
• Heike Deters, Head of Compliance, Bayer Healthcare China
• Dr Wang Xianlin, Member, Expert Advisory Group of Anti-Monopoly Commission, State Council People’s Republic of China
• Maija Burtmanis, Regional Legal & Compliance Director JAPAC, AbbVie
• Gareth Lee, General Counsel & Head of Compliance APAC, Allergan
• Cristopher Landrito, Regional Compliance Manager APAC, Merck
• David Shen, General Counsel & VP Legal, AstraZeneca China
• Dr Wu Ke, President, Shanghai BravoBio
• Alejandro Castro, Regional Audit Manager Asia Pacific, Novartis
• Linda Ling, Senior Healthcare Compliance Manager, OTC China, Johnson & Johnson
http://www.pharmacompliance-china.com
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.
This document provides an overview of ISO 15189:2007, which establishes particular requirements for quality and competence in medical laboratories. It discusses the history and development of the standard, as well as key clauses related to organization, management, quality systems, personnel, equipment, pre-examination procedures, and more. The document is intended to train readers on the requirements of ISO 15189 through paraphrasing and rewording the standard.
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.
PHARMACEUTICAL QUALITY ASSURANCE : Mr. Prashant JadhavPRASHANT JADHAV
The document discusses quality assurance and good manufacturing practices in the pharmaceutical industry. It defines quality assurance according to WHO as activities that provide confidence that quality requirements are being met. Quality assurance is part of quality management and includes planned activities to ensure products and services meet quality standards. Good manufacturing practices are regulations and guidelines for manufacturing drugs, medical devices, and foods to minimize risks that cannot be eliminated through testing. GMPs help ensure drug products are safe, pure and effective.
Quality Assurance and Regulatory Compliance for Pharmaceutical Product, Prof. Dr. Basavaraj K. Nanjwade, KLE University College of Pharmacy, Belgaum/Belagavi
As you know, pharma compliance is a critical issue, particularly in China. The Chinese government’s recent crackdowns on the business practices of various pharmaceutical companies have sent shockwaves throughout the industry and the price to pay for non-compliance is exceedingly high, with massive revenue losses and irreclaimable reputational damages
To address this pertinent issue, IBC Asia is convening the forthcoming Pharma Compliance Summit
(Mar 2015) in Shanghai, China. Set to be an informative and insightful event, this conference will prepare participants in dealing with the latest legal compliance landmines and equip them with an in-depth understanding of how to mitigate non- compliance risks at every part of the pharma value chain.
Top companies will share best practices of internal compliance programs and third party due diligence strategies; Gain these exclusive insights and incorporate them into their own company, reaping maximum benefits.
Your expert speaker faculty includes:
• Leon Wang, Vice President, AstraZeneca China
• Heike Deters, Head of Compliance, Bayer Healthcare China
• Dr Wang Xianlin, Member, Expert Advisory Group of Anti-Monopoly Commission, State Council People’s Republic of China
• Maija Burtmanis, Regional Legal & Compliance Director JAPAC, AbbVie
• Gareth Lee, General Counsel & Head of Compliance APAC, Allergan
• Cristopher Landrito, Regional Compliance Manager APAC, Merck
• David Shen, General Counsel & VP Legal, AstraZeneca China
• Dr Wu Ke, President, Shanghai BravoBio
• Alejandro Castro, Regional Audit Manager Asia Pacific, Novartis
• Linda Ling, Senior Healthcare Compliance Manager, OTC China, Johnson & Johnson
http://www.pharmacompliance-china.com
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.
This document provides an overview of ISO 15189:2007, which establishes particular requirements for quality and competence in medical laboratories. It discusses the history and development of the standard, as well as key clauses related to organization, management, quality systems, personnel, equipment, pre-examination procedures, and more. The document is intended to train readers on the requirements of ISO 15189 through paraphrasing and rewording the standard.
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.
PHARMACEUTICAL QUALITY ASSURANCE : Mr. Prashant JadhavPRASHANT JADHAV
The document discusses quality assurance and good manufacturing practices in the pharmaceutical industry. It defines quality assurance according to WHO as activities that provide confidence that quality requirements are being met. Quality assurance is part of quality management and includes planned activities to ensure products and services meet quality standards. Good manufacturing practices are regulations and guidelines for manufacturing drugs, medical devices, and foods to minimize risks that cannot be eliminated through testing. GMPs help ensure drug products are safe, pure and effective.
Medical Laboratory Accreditation (ISO 15189)IBEX SYSTEMS
ISO 15189 is an international standard that specifies requirements for quality and competence in medical laboratories. It is used to confirm the competence of medical laboratories for customers, regulating authorities, and accreditation bodies. Obtaining ISO 15189 certification can improve laboratory services, products, and processes. It also provides benefits like a reputable image, increased business, international recognition, compliance with regulations, efficiency, and quality control. Consulting companies can help laboratories achieve ISO 15189 accreditation through activities like gap analysis, documentation, implementation, auditing, and continual improvement support.
Good Manufacturing Practices (GMP) ensure consistency in the quality of pharmaceutical products. GMP guidelines cover quality control, documentation, personnel qualifications, premises, equipment, materials, production, and quality assurance. Adherence to GMP is important for pharmaceutical export and most regulatory agencies only approve imports of medicines made under GMP standards. Key aspects of GMP include qualification and validation of equipment and processes, complaint handling, recalls, and self-inspections. GMP guidelines also exist specifically for herbal medicines to ensure quality, safety and efficacy of these complex biological products.
Effectiveness of ISO 15189 2012: a requirement for medical laboratories with ...iosrjce
IOSR Journal of Business and Management (IOSR-JBM) is a double blind peer reviewed International Journal that provides rapid publication (within a month) of articles in all areas of business and managemant and its applications. The journal welcomes publications of high quality papers on theoretical developments and practical applications inbusiness and management. Original research papers, state-of-the-art reviews, and high quality technical notes are invited for publications.
Auditing of vendors and production departmentPRANJAY PATIL
The document discusses vendor audits in the pharmaceutical industry. It provides details on the objectives, parameters, and steps of conducting a vendor audit. The key points are:
- Vendor audits assess a vendor's quality management system, practices, documentation, and adherence to standards to ensure their products and services meet requirements.
- Important parameters reviewed include ISO certifications, manufacturing facilities, packaging and labeling standards, and data handling procedures.
- The goals are to evaluate quality control measures and management commitment to quality standards required by regulations.
- Conducting vendor audits helps reduce costs and risks by gaining insight into supplier processes and compliance.
This document discusses auditing of vendors that supply capsules and sterile products to pharmaceutical companies. It describes the benefits of conducting vendor audits such as cost savings, process improvements, and risk reduction. The document outlines the vendor selection process and procedures for auditing vendors. Key areas examined in a vendor audit include facilities, personnel, validation, documentation, and finished product quality controls. Manufacturing processes for capsules and sterile products are also summarized. The checklist covers auditing of vendors' premises, equipment, documentation, samples, and compliance with regulations.
Medical laboratory services play an essential role in patient diagnosis and health assessment. ISO 15189 provides an international standard for medical laboratories to demonstrate their technical competence and quality management systems. Accreditation to ISO 15189 involves an independent assessment of a laboratory's personnel, facilities, equipment, procedures, and quality assurance practices. It helps ensure patients, clinicians, and other stakeholders receive accurate and reliable test results in a timely manner.
Auditing of vendors and production departmentArpitSuralkar
This document outlines procedures for auditing vendors that produce capsules and sterile products. It discusses the benefits of vendor audits such as cost savings, process improvements, and risk reduction. The document describes the vendor selection process and provides a checklist for auditing vendors, which includes evaluating their premises, personnel, documentation, validation procedures, samples, stability studies, and drug recall processes. The goal of vendor audits is to inspect vendors' quality management systems and ensure they meet requirements for producing capsules and sterile medical products.
Total quality management for medical labs ravi kumudeshRavi Kumudesh
Ensuring establishment of QMS
Implementation and Maintain QMS
Maintain Quality policy
Assist to documentation of Quality Objective
Assist to establishment of Quality Objective
Crate awareness of users in the lab
Assist preparation, administration, dissemination and regular review of quality Manual
Assist to maintaining document Control System,
Maintain Technical Records
Assist to control clinical material
Participate to Management Review
An audit of a microbiology laboratory involves independently reviewing the laboratory's records, operations, and procedures to evaluate efficiency, effectiveness, compliance, and risk mitigation. The objectives are to determine the quality systems in place, the knowledge and capabilities of audited staff, and whether continuous improvement is part of the culture. Principles of efficient auditing include proper preparation, documentation, adherence to methods and standard operating procedures, and staff proficiency demonstrations. Types of audits include those of contract manufacturers, contract laboratories, ingredient suppliers, and internal audits. A micro audit works backwards or forwards from samples to comprehensively evaluate microbiological control. The auditing process consists of planning, on-site information gathering, report preparation, exit meeting,
This document provides information about in-process quality control (IPQC) for a student named Pournima Ashok guided by Mrs. M. Harde. It defines IPQC as checks performed during production to monitor and adjust the process to ensure the product meets specifications. This may include controlling the environment or equipment. IPQC is intended to minimize errors, provide accurate procedures, detect errors, allow for corrective actions, identify responsibilities, and enforce established manufacturing and packing operations. Examples of IPQC for tablets include testing for container content uniformity, active ingredient content, tablet thickness, hardness, friability, and disintegration. Friability testing evaluates the tendency of tablets to fragment or powder during storage and handling.
Auditing of Granulation Operation in Dry Production AreaPritam Kolge
Auditing of Granulation Operation in Dry Production Area.....
This topic comes under Audits and Regulatory Compliance....
This is useful for M.Pharm (Pharaceutical Quality Assurance) Students who studying in First year sem II....
This Presentation Contain following...
#Objectives
#Fundamentals of Granulation
#Reasons for Granulation
#Methods of Granulation
#Agglomeration
#Fundamentals and Audit of Dry Granulation
#Steps in Dry Granulation
#Fundamentals and Audit of Fluid Bed Granulation
#Scale-Up of Fluid bed Granulation
#High share granulation-Fundamentals, Audit and Scale-Up
#Overview and Comparison of Different Granulating Techniques
#Audit of Mixing and Blending, Wet granulation, Wet milling, Drying, Milling
#Conclusion
#References
Thanks For Help and Guidance of Mr. D.P.Mali Sir
1. Auditing of microbiology laboratories is important to determine the quality systems, knowledge, capabilities, and culture of continuous improvement.
2. There are six principles of efficient auditing including correct preparation, documentation, adherence to requirements and procedures, and proficiency demonstrations.
3. Types of audits include those of contract manufacturers, laboratories, excipient/active ingredient manufacturers, and internal audits, with vertical audits encompassing more aspects of the process.
This document discusses in-process quality assurance in pharmaceutical manufacturing. It defines quality as meeting consumer needs and outlines how quality is built into the manufacturing process through controls like following good manufacturing practices, input material control, process control, in-process checks, cross-checking, and product release controls. The document explains that in-process quality assurance is important to ensure products are consistently manufactured to quality standards by guiding operators about any deviations observed during production. It provides examples of in-process checks for various unit operations like blending, compression, and coating. The overall goal of in-process quality assurance is to reduce batch rejections and reprocessing by adopting controls that build quality into each stage of the manufacturing process.
This document outlines Good Laboratory Practices (GLP) that should be followed to obtain reliable results for pharmaceutical and biopharmaceutical laboratories. It discusses the objectives of GLP as ensuring regulatory compliance and producing true and reproducible data. It then provides guidance on various aspects of GLP compliance including personnel qualifications, facility and equipment requirements, method validation, sampling practices, documentation, and consequences of non-compliance. The overall goal of the GLP guidelines is to minimize errors and produce high quality results through standardized, documented processes.
Present industry expectations from pharmacy studentsMalay Singh
The document discusses expectations from pharmacy students and institutions by the pharmaceutical industry. It notes that current graduates lack practical skills and awareness of industry trends. It calls for periodic updates to pharmacy curricula to reflect rapid changes in the industry's focus, direction, and functioning. The expectations of key industry departments like R&D, clinical research, quality assurance, and regulatory affairs are outlined. These include training students in areas like drug development, clinical trials, quality control, and regulatory guidelines. The document recommends reforms to teaching methods and greater industry exposure for faculty and students through workshops, training, and consultancy to bridge gaps between education and industry needs.
ISO 15189 Accreditation Guide - Improving Laboratory Performance Through Qual...Randox
The document discusses ISO 15189 accreditation for medical laboratories. It outlines the importance of quality control and differences between accreditation and certification. Laboratories must implement both internal quality control and external quality assessment to gain ISO 15189 accreditation. This involves using third party controls, clinically relevant quality control material levels, peer group reporting, and participation in external quality assessment schemes. The document provides guidance on quality control considerations and processes needed to achieve and maintain ISO 15189 accreditation.
Industry Program In Pharma Quality Assurance And Quality Controlbiinoida
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. Participants can pursue careers in quality assurance, control, engineering, and management and work for major pharmaceutical companies upon completion.
This curriculum vitae summarizes Tanveer Ahmed's qualifications and experience in quality assurance. He has over 10 years of experience in quality assurance, validation, and quality control, working for several pharmaceutical companies in Bangladesh. His experience includes international regulatory inspections and working with an FDA consultant. He held positions such as Quality Assurance Manager and QA In-Charge. He has a Bachelor of Pharmacy degree and training in topics such as quality management, EU GMP guidelines, cleaning validation, and sterile facility operation.
Quality assurance ensures that pharmaceutical products meet the required quality standards for their intended use. It encompasses all activities that maintain and improve product quality, including following good manufacturing practices and other quality regulations. A quality assurance system specifies manufacturing and quality control procedures in written documents. It also monitors materials, processes, products, documentation, complaints, and ongoing quality improvement. Key quality assurance activities involve technology transfer, validation, documentation, auditing manufacturing quality, and developing quality improvement plans.
Medical Laboratory Accreditation (ISO 15189)IBEX SYSTEMS
ISO 15189 is an international standard that specifies requirements for quality and competence in medical laboratories. It is used to confirm the competence of medical laboratories for customers, regulating authorities, and accreditation bodies. Obtaining ISO 15189 certification can improve laboratory services, products, and processes. It also provides benefits like a reputable image, increased business, international recognition, compliance with regulations, efficiency, and quality control. Consulting companies can help laboratories achieve ISO 15189 accreditation through activities like gap analysis, documentation, implementation, auditing, and continual improvement support.
Good Manufacturing Practices (GMP) ensure consistency in the quality of pharmaceutical products. GMP guidelines cover quality control, documentation, personnel qualifications, premises, equipment, materials, production, and quality assurance. Adherence to GMP is important for pharmaceutical export and most regulatory agencies only approve imports of medicines made under GMP standards. Key aspects of GMP include qualification and validation of equipment and processes, complaint handling, recalls, and self-inspections. GMP guidelines also exist specifically for herbal medicines to ensure quality, safety and efficacy of these complex biological products.
Effectiveness of ISO 15189 2012: a requirement for medical laboratories with ...iosrjce
IOSR Journal of Business and Management (IOSR-JBM) is a double blind peer reviewed International Journal that provides rapid publication (within a month) of articles in all areas of business and managemant and its applications. The journal welcomes publications of high quality papers on theoretical developments and practical applications inbusiness and management. Original research papers, state-of-the-art reviews, and high quality technical notes are invited for publications.
Auditing of vendors and production departmentPRANJAY PATIL
The document discusses vendor audits in the pharmaceutical industry. It provides details on the objectives, parameters, and steps of conducting a vendor audit. The key points are:
- Vendor audits assess a vendor's quality management system, practices, documentation, and adherence to standards to ensure their products and services meet requirements.
- Important parameters reviewed include ISO certifications, manufacturing facilities, packaging and labeling standards, and data handling procedures.
- The goals are to evaluate quality control measures and management commitment to quality standards required by regulations.
- Conducting vendor audits helps reduce costs and risks by gaining insight into supplier processes and compliance.
This document discusses auditing of vendors that supply capsules and sterile products to pharmaceutical companies. It describes the benefits of conducting vendor audits such as cost savings, process improvements, and risk reduction. The document outlines the vendor selection process and procedures for auditing vendors. Key areas examined in a vendor audit include facilities, personnel, validation, documentation, and finished product quality controls. Manufacturing processes for capsules and sterile products are also summarized. The checklist covers auditing of vendors' premises, equipment, documentation, samples, and compliance with regulations.
Medical laboratory services play an essential role in patient diagnosis and health assessment. ISO 15189 provides an international standard for medical laboratories to demonstrate their technical competence and quality management systems. Accreditation to ISO 15189 involves an independent assessment of a laboratory's personnel, facilities, equipment, procedures, and quality assurance practices. It helps ensure patients, clinicians, and other stakeholders receive accurate and reliable test results in a timely manner.
Auditing of vendors and production departmentArpitSuralkar
This document outlines procedures for auditing vendors that produce capsules and sterile products. It discusses the benefits of vendor audits such as cost savings, process improvements, and risk reduction. The document describes the vendor selection process and provides a checklist for auditing vendors, which includes evaluating their premises, personnel, documentation, validation procedures, samples, stability studies, and drug recall processes. The goal of vendor audits is to inspect vendors' quality management systems and ensure they meet requirements for producing capsules and sterile medical products.
Total quality management for medical labs ravi kumudeshRavi Kumudesh
Ensuring establishment of QMS
Implementation and Maintain QMS
Maintain Quality policy
Assist to documentation of Quality Objective
Assist to establishment of Quality Objective
Crate awareness of users in the lab
Assist preparation, administration, dissemination and regular review of quality Manual
Assist to maintaining document Control System,
Maintain Technical Records
Assist to control clinical material
Participate to Management Review
An audit of a microbiology laboratory involves independently reviewing the laboratory's records, operations, and procedures to evaluate efficiency, effectiveness, compliance, and risk mitigation. The objectives are to determine the quality systems in place, the knowledge and capabilities of audited staff, and whether continuous improvement is part of the culture. Principles of efficient auditing include proper preparation, documentation, adherence to methods and standard operating procedures, and staff proficiency demonstrations. Types of audits include those of contract manufacturers, contract laboratories, ingredient suppliers, and internal audits. A micro audit works backwards or forwards from samples to comprehensively evaluate microbiological control. The auditing process consists of planning, on-site information gathering, report preparation, exit meeting,
This document provides information about in-process quality control (IPQC) for a student named Pournima Ashok guided by Mrs. M. Harde. It defines IPQC as checks performed during production to monitor and adjust the process to ensure the product meets specifications. This may include controlling the environment or equipment. IPQC is intended to minimize errors, provide accurate procedures, detect errors, allow for corrective actions, identify responsibilities, and enforce established manufacturing and packing operations. Examples of IPQC for tablets include testing for container content uniformity, active ingredient content, tablet thickness, hardness, friability, and disintegration. Friability testing evaluates the tendency of tablets to fragment or powder during storage and handling.
Auditing of Granulation Operation in Dry Production AreaPritam Kolge
Auditing of Granulation Operation in Dry Production Area.....
This topic comes under Audits and Regulatory Compliance....
This is useful for M.Pharm (Pharaceutical Quality Assurance) Students who studying in First year sem II....
This Presentation Contain following...
#Objectives
#Fundamentals of Granulation
#Reasons for Granulation
#Methods of Granulation
#Agglomeration
#Fundamentals and Audit of Dry Granulation
#Steps in Dry Granulation
#Fundamentals and Audit of Fluid Bed Granulation
#Scale-Up of Fluid bed Granulation
#High share granulation-Fundamentals, Audit and Scale-Up
#Overview and Comparison of Different Granulating Techniques
#Audit of Mixing and Blending, Wet granulation, Wet milling, Drying, Milling
#Conclusion
#References
Thanks For Help and Guidance of Mr. D.P.Mali Sir
1. Auditing of microbiology laboratories is important to determine the quality systems, knowledge, capabilities, and culture of continuous improvement.
2. There are six principles of efficient auditing including correct preparation, documentation, adherence to requirements and procedures, and proficiency demonstrations.
3. Types of audits include those of contract manufacturers, laboratories, excipient/active ingredient manufacturers, and internal audits, with vertical audits encompassing more aspects of the process.
This document discusses in-process quality assurance in pharmaceutical manufacturing. It defines quality as meeting consumer needs and outlines how quality is built into the manufacturing process through controls like following good manufacturing practices, input material control, process control, in-process checks, cross-checking, and product release controls. The document explains that in-process quality assurance is important to ensure products are consistently manufactured to quality standards by guiding operators about any deviations observed during production. It provides examples of in-process checks for various unit operations like blending, compression, and coating. The overall goal of in-process quality assurance is to reduce batch rejections and reprocessing by adopting controls that build quality into each stage of the manufacturing process.
This document outlines Good Laboratory Practices (GLP) that should be followed to obtain reliable results for pharmaceutical and biopharmaceutical laboratories. It discusses the objectives of GLP as ensuring regulatory compliance and producing true and reproducible data. It then provides guidance on various aspects of GLP compliance including personnel qualifications, facility and equipment requirements, method validation, sampling practices, documentation, and consequences of non-compliance. The overall goal of the GLP guidelines is to minimize errors and produce high quality results through standardized, documented processes.
Present industry expectations from pharmacy studentsMalay Singh
The document discusses expectations from pharmacy students and institutions by the pharmaceutical industry. It notes that current graduates lack practical skills and awareness of industry trends. It calls for periodic updates to pharmacy curricula to reflect rapid changes in the industry's focus, direction, and functioning. The expectations of key industry departments like R&D, clinical research, quality assurance, and regulatory affairs are outlined. These include training students in areas like drug development, clinical trials, quality control, and regulatory guidelines. The document recommends reforms to teaching methods and greater industry exposure for faculty and students through workshops, training, and consultancy to bridge gaps between education and industry needs.
ISO 15189 Accreditation Guide - Improving Laboratory Performance Through Qual...Randox
The document discusses ISO 15189 accreditation for medical laboratories. It outlines the importance of quality control and differences between accreditation and certification. Laboratories must implement both internal quality control and external quality assessment to gain ISO 15189 accreditation. This involves using third party controls, clinically relevant quality control material levels, peer group reporting, and participation in external quality assessment schemes. The document provides guidance on quality control considerations and processes needed to achieve and maintain ISO 15189 accreditation.
Industry Program In Pharma Quality Assurance And Quality Controlbiinoida
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. Participants can pursue careers in quality assurance, control, engineering, and management and work for major pharmaceutical companies upon completion.
This curriculum vitae summarizes Tanveer Ahmed's qualifications and experience in quality assurance. He has over 10 years of experience in quality assurance, validation, and quality control, working for several pharmaceutical companies in Bangladesh. His experience includes international regulatory inspections and working with an FDA consultant. He held positions such as Quality Assurance Manager and QA In-Charge. He has a Bachelor of Pharmacy degree and training in topics such as quality management, EU GMP guidelines, cleaning validation, and sterile facility operation.
Quality assurance ensures that pharmaceutical products meet the required quality standards for their intended use. It encompasses all activities that maintain and improve product quality, including following good manufacturing practices and other quality regulations. A quality assurance system specifies manufacturing and quality control procedures in written documents. It also monitors materials, processes, products, documentation, complaints, and ongoing quality improvement. Key quality assurance activities involve technology transfer, validation, documentation, auditing manufacturing quality, and developing quality improvement plans.
The document is a curriculum vitae for S. Kalithas seeking a quality control or quality assurance role in the pharmaceutical or FMCG sector. It summarizes his over 10 years of experience in pharmaceutical quality control, including his current role as Deputy Manager of Quality Control at Biocon Ltd since 2008 where he manages a team of 8 members and oversees analytical work, documentation, and ensuring compliance. It also lists his educational qualifications including an MSc in Chemistry from Madurai Kamaraj University in 2003.
This document provides an overview of quality assurance, good manufacturing practices (GMP), and good laboratory practices (GLP). It defines each concept and outlines their key principles and goals. Quality assurance aims to ensure products meet the required quality standards and involves implementing GMP, GLP, and other quality control measures. GMP focuses on establishing processes to minimize risks like contamination during manufacturing. GLP provides a quality system for non-clinical health and safety studies to ensure they are properly planned, performed, documented and reported.
This document discusses the validation of raw materials used in pharmaceutical manufacturing. It defines validation as demonstrating through documented evidence that a process will consistently produce a product meeting predetermined specifications. The document outlines a 7 step process for validating raw materials: 1) List all raw materials needed, 2) Identify at least two suppliers for each material, 3) Qualify new suppliers by inspecting facilities, 4) Obtain supplier certificates of analysis and samples, 5) Establish specifications for each material, 6) Establish test procedures, 7) Establish sampling procedures. The validation process confirms raw materials meet specifications and ensures uniform, high quality batches.
The document is a curriculum vitae for Dr. Zakia Saeed, who has over 15 years of experience in pharmaceutical quality control, quality assurance, and regulatory affairs. She holds a PhD and MPhil in Pharmaceutical Chemistry from Karachi University. Her experience includes positions as Quality Control & Quality Assurance Manager at C.K.D Pharmaceuticals Pakistan and Senior Manager of Quality Assurance & Regulatory Affairs at Medisure Laboratories Pakistan, where she oversaw quality management, inspections, and regulatory compliance. She is skilled in methods validation, documentation, auditing, and ensuring compliance with cGMP standards.
This document discusses quality assurance and regulatory compliance for pharmaceutical products. It describes quality assurance as ensuring that products meet the requirements for their intended use. This involves following good manufacturing practices (GMP) and having systems in place for production, quality control, documentation, validation, complaint handling and stability testing. Regulatory compliance requires understanding requirements for approval in different countries or regions and compiling dossiers to register products. Together, quality assurance and regulatory compliance aim to build quality into products and ensure they meet all necessary standards and regulations.
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.
Quality assurance is essential for ensuring pharmaceutical products meet quality standards for their intended use. It involves establishing controls throughout the development and manufacturing processes. This includes designing products based on GMP, GLP and other standards, specifying control operations in writing, and establishing in-process and finished product testing. Managerial responsibilities and change control systems are also important aspects of quality assurance. The goal is consistently producing products that conform to their marketing authorizations and regulatory requirements.
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.
It's an assignment on selected topics on Pharmaceuticals. Which are
1. Quality Management system in Pharmaceutical Industry
2. Quality Assurance and Quality Control in Pharmaceutical Industry
3. Difference between Quality Assurance and Quality Control
4. Briefly describe Pharmacopoeia, Drug Formulary, Drug compendia,
Pharmaceutical codex
5. Short notes on British Pharmacopoeia, US Pharmacopoeia,
European Pharmacopoeia, Japanese Pharmacopoeia, British
Pharmaceutical Codex
6. What is monograph in Pharmacopoeia? What does it contain?
Saurabh Pathak has over 11 years of experience in bioequivalence and clinical research. He holds a Master's degree in Pharmacology and a Bachelor's degree in Pharmacy. Currently he is the Group Leader and Manager of the Clinical Division at Alembic Pharmaceuticals, where he supervises a team of 17 employees. His responsibilities include project management, regulatory compliance, medical writing, and clinical study monitoring. He has extensive experience managing bioequivalence studies and has led inspections by various regulatory agencies.
Concepts of GLP and ISO 9000. The Good Laboratory Practices Guideline (GLP) is an FDA regulation. Good Laboratory Practices (GLP) embodies a set of principles that provides a framework within which laboratory studies are planned, performed, monitored, recorded and reported. National Good Laboratory Practice (GLP) Compliance Monitoring Authority (NGCMA). NGCMA was established by the Department of Science & Technology (DST), Government of India, with the approval of the Union Cabinet on April 24, 2002.
ISO 9000 is a series of standards, developed and published by the International Organization for Standardization (ISO), which is an independent, non-governmental organization made up of members from over 160 countries.
The ISO 9000 family of standards is related to Quality Management Systems and designed to help organizations ensure that they meet the needs of customers and other stakeholders while meeting statutory and regulatory requirements. ISO 9000 deals with the fundamentals of quality management systems, including the 7 Quality Management Principles on which the family of standards is based.
This document discusses key concepts related to quality assurance and quality management in the pharmaceutical industry. It defines quality and explains that for a pharmaceutical product to be of good quality, it must meet specifications for identity, strength, purity, safety, and efficacy. Quality assurance aims to ensure products fulfill requirements through processes, while quality control tests finished products. Good manufacturing practices provide standards for production to minimize risks. Together, quality assurance, quality control, and GMP work to consistently produce safe, effective pharmaceuticals.
This document provides a summary of Christine Marie C. Garcia's work experience and qualifications. She has over 6 years of experience in quality assurance and validation roles at Pascual Laboratories Inc., including positions as Technical Assurance Specialist, Cleaning Validation Officer, and QA Validation Officer. She holds a Bachelor of Science in Pharmacy degree from Centro Escolar University and is a licensed pharmacist in the Philippines. Her most recent role as Technical Assurance Specialist involves investigating and resolving technical and quality issues for products.
The document discusses key concepts in Quality by Design (QbD) for pharmaceutical product development, including:
- Critical quality attributes and critical material/process parameters that can impact product quality
- Risk assessment tools to identify parameters affecting quality and rank their risks
- Design of experiments to understand relationships between factors and responses
- Establishing a design space based on understanding of material attributes and process parameters and their interactions/impacts on quality
- Defining control strategies within the design space to ensure consistent and robust quality
V.G. Shashi Vardhan is seeking a challenging position in an organization where he can improve his knowledge and skills. He has over 8 years of experience in quality assurance and microbiology roles at pharmaceutical companies. His responsibilities have included auditing, validation, documentation, environmental monitoring, method development, and ensuring compliance. He is proficient in various instruments and has participated in regulatory audits. He holds an M.S. in Microbiology and has undergone training in areas such as GMP, team building, and auditing.
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1. Quality Assurance and Regulatory
Compliance for Pharmaceutical Product
Prof. Dr. Basavaraj K. Nanjwade M. Pharm., Ph. D
Department of Pharmaceutics
KLE University College of Pharmacy
BELGAUM-590010, Karnataka, India
E-mail: bknanjwade@yahoo.co.in
Cell No: 00919742431000
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Maharashtra College of Pharmacy, Nilanga
2. Quality Assurance
Quality assurance is a wide ranging concept covering
all matters that individually or collectively influence the
quality of a product.
It is the totality of the arrangements made with the
object of ensuring that pharmaceutical products are of
the quality required for their intended use.
QA is the heart and soul of quality control
QA = QC + GMP
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3. The System of Quality Assurance
Pharmaceutical products are designed and developed
in a way that takes account of the requirements of
GMP and other associated codes such as those of
good laboratory practice (GLP) and good clinical
practice (GCP)
Product and control operations are clearly specified in
a written form and GMP requirements are adopted
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4. The System of Quality Assurance
Managerial responsibilities are clearly specified in
job description
Arrangements are made for the manufacture, supply
and use of the correct starting and packaging
materials.
All necessary controls on starting materials,
intermediate products, and bulk products and other
in-process controls, calibrations, and validations are
carried out.
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5. The System of Quality Assurance
The finished products is correctly processed and
checked according to the defined procedures.
Pharmaceutical products are not sold or supplied
before the authorized persons have certified that each
production batch has been produced and controlled in
accordance with the requirements of the marketing
authorization and any other regulations relevant to the
production, control and release of pharmaceutical
products
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6. The System of Quality Assurance
Satisfactory arrangements exist to ensure, as far as
possible, that the pharmaceutical products are stored
by the manufacturer, distributed and subsequently
handled so that quality is maintained throughout their
shelf-life.
There is a procedure for self-inspection and/or quality
audit that regularly appraises the effectiveness and
applicability of the quality assurance system
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7. The System of Quality Assurance
Deviation are reported, investigated and recorded
There is a system for approving changes that may
have an impact on product quality
Regular evaluations of the quality of pharmaceutical
products should be conducted with the objective of
verifying the consistency of the process and ensuring
its continuous improvement.
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9. Quality Assurance
It is the sum total of the
organized arrangements with
the objective of ensuring that
products will be of the
quality required for their
intended use
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10. Good Manufacturing Practice
Is that part of Quality
Assurance aimed at ensuring
that products are
consistently manufactured to
a quality appropriate to their
intended use
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11. Good Manufacturing Practice
• Raw or starting materials
• Finished products
• Premises and environment
• Equipment
• personnel
• Training
• Hygiene
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GMP Covers all aspects of production including
13. Quality Control
Is that part of GMP concerned
with sampling, specification
& testing, documentation &
release procedures which
ensure that the necessary &
relevant tests are performed
& the product is released for
use only after ascertaining
it’s quality
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14. QA and QC
QC is that part of GMP
which is concerned with
sampling,
specifications, testing and
with in the organization,
documentation,and
release procedures which
ensure that the necessary
and relevant tests are
carried out
• QA is the sum total of
organized
arrangements made
with the object of
ensuring that product
will be of the Quality
required by their
intended use.
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15. QA and QC
Operational
laboratory techniques
and activities used to
fulfill the requirement
of Quality
• All those planned or
systematic actions
necessary to
provide adequate
confidence that a
product will satisfy
the requirements for
quality
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16. QA and QC
QC is lab based
• QA is company
based
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17. 04th Oct. 2011 17
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18. 04th Oct. 2011 18
Maharashtra College of Pharmacy, Nilanga
19. Quality Assurance-Highlights
In process quality checking in manufacturing
Validation of facilities, equipments, process,
products and cleaning
Complaint handling
Storage of quality records and control samples
Stability studies
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20. Quality Assurance Activities
1. Technology Transfer
2. Validation
3. Documentation Control
4. Assuring Quality of Products
5. Quality Improvement Plans
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21. 1. Technology Transfer
Receipt of product design documents from R & D
Department
Distribution of documents to different departments
Checking and approval of documents generated based
on R & D documents i.e. batch manufacturing record
Scale up and validation of product
‐
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22. 2. Validation
• Preparation of validation plans for facility,
equipments/process including cleaning
• Approval of protocol for validation of facility
/equipment /product /process
• Team member for execution of validation of
facility/equipment/ product/process
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23. 3. Documentation Control
Controlled distribution and archiving of documents
Control of changes made by proper change control
procedure
Approval of all documents
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24. 4. Assuring Quality of Products
cGMP training
SOP compliance
Audit of facility for compliance
Line clearance
In process counter checks
‐
Critical sampling
Record verification
Release of batch for marketing
Investigation of market complaints
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25. 5. Quality Improvement Plans
To take Feedback from different departments
Proposals for corrective and preventive actions
Annual Products review
Trend analysis of various quality parameters for
products, environment and water
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26. FACTORS IN DRUG QUALITY ASSURANCE
DRUG
PRODUCT
QUALITY
Labeling &
Product
Information
Import
& Export
Control
Raw
Materials-
Active &
Inactive
Manufacturing
Processes
& Procedures Storage
Transport
Distribution
Dispensing
& Use
QC &
Analysis
Human
Resources-
Professionals
Legislative
Framework
-Regulations Packaging
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28. • In process quality checking in manufacturing
• Validation of facilities, equipments, process,
products and cleaning
• Complaint handling
• Storage of quality records and control
samples
• Stability studies
Quality Assurance
Highlights
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29. 04th Oct. 2011 29
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30. Equipment /Instrument Qualification
Before a process can be validated the equipment,
facilities & services used in that process must
themselves be validated such an operation is referred
to as qualification
Qualification therefore, an integral part of process
validation which in turn is part of GMP
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33. Why to qualify
If the instrument is not qualified prior to use & if a problem
occurs, the source of problem will be difficult to identify.
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35. Details Record in Change Control
Request for change
Change control No.
Date
Change related to
product/document/system/facility
Concerned documents with number
Description of change
Reason for change
Impact of change
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36. Details Record in Change Control
Proposed methodology for implementation
Category of change
Type of change
Comparison criteria for evaluation of the
change
Assessment of impact of change
Approval of change
Implementation of change
Closure of change
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37. Details Recorded in Deviation Approval
Deviation no.
Deviation related to
Concerned identity number (Batch No., Code No. etc)
Type of deviation (Planed/Unplaned)
Description of deviation
Reason/Investigation with document
Category of deviation
Root cause analysis
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38. Details Recorded in Deviation Approval
Impact of deviation (on batches, Products, Items, etc)
Immediate action
CAPA (Corrective and Preventive Action)
Impact of CAPA
Intimation to concerned
Comments from concerned
Periodic review
Final review
Deviation close-out
Evaluation of implemented CAPA
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39. Details Recorded In Out of Specification Report
OOS No. (Out of Specification)
Reporting of OOS
Information of OOS to immediate senior
Assessment of analytical data by immediate senior
Discussion between analyst and immediate senior
Sampling and analysis
Data compilation
Assignable cause identification
Full scale OOS investigation (Cause not identified)
Evaluation
Conclusion
CAPA
OOS results summary
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40. Area of Self Inspection
Personal & Personal details
Premises including personnel facilities
Maintenance of building & equipment
Storage of starting material & finished products (Stores)
Equipment
Production & In-process controls
Cephalosporin Mfg & Packing
Manufacturing
Packing
Quality control
Documentation
Sanitation & Hygiene
Validation and revalidation program
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41. Areas of Self Inspection
Calibration of instruments or measurement system
Recall procedure
Complaints management
Labels control
Computerized system
Engineering
Documents related to regulatory affairs
Discarding of residues
Quality assurance
Control on contract analysis
Results of previous self inspection, quality audit and any
corrective steps taken
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Maharashtra College of Pharmacy, Nilanga
42. Details Recorded in Complaint Investigation Report
Complaint No.
Product Name
Manufacturing and Expiry of product
Source of complaint
Date of receipt of complaint
Nature of complaint
Category of complaint
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43. Details Recorded in Complaint Investigation Report
Investigation
Impact of complaint on other batches/products
Batches/Products
Review
CAPA
Impact of CAPA
Implementation of Preventive action
Close out of complaint
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44. Acceptance Criteria
Sr. No. RPN Rating RPN Category
1. Up to 25 Minor
2. 26 to 50 Moderate
3. 51 to 75 Major
4. 76 to ≤125 Critical
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RPN: Risk Priority Number
45. 04th Oct. 2011 45
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48. Regulatory Requirements
Regulatory requirements are part of the process of drug
discovery and drug development.
Regulatory requirements describe what is necessary for a new
drug to be approved for marketing in any particular country.
In the US, it is the function of the Food and Drug
Administration (FDA) to establish these regulatory
requirements.
The European Medicines Agency (EMA) and
Japanese Pharmaceuticals and Medical Devices Agency
(PMDA) are also important regulatory authorities in drug
development. These three agencies oversee the three largest
markets for drug sales
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49. Regulatory Compliance
In general, compliance means conforming to
a rule, such as a specification, policy, standard
or law.
Regulatory compliance describes the goal
that corporations or public agencies aspire to
in their efforts to ensure that personnel are
aware of and take steps to comply with
relevant laws and regulations.
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50. Pharmaceutical Product Quality Cannot Be Tested in - It
Is Built in
Pharmaceutical product quality is assured by
Comprehensive development program
Extensive manufacturing and environmental
controls
Rigorous validation procedures and
requirements
Compliance to regulatory requirements
The high quality thus built into the final product is ensured through
in-process controls and verified in a series of confirmatory tests
before each manufactured batch is released to the market
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51. Quality = Quality of Manpower (Qualification, Training…)
+ Quality of Materials (Specifications, Approved Suppliers...)
+ Quality of Means (Qualified equipments, maintenance…)
+ Quality of Media (GMP premises, Controlled environment…)
+ Quality of Methods (Calibration, Validation…)
Product / Service
Materials
Methods
Means
Manpower
Media
Composition of Quality
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52. Functions of a Quality Unit
Quality Control
–Sampling and testing of components
(raw materials, Packing materials),
intermediates and finished products
–Compliance to Good Laboratory
Practices (GLPs)
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53. Functions of a Quality Unit
Quality Assurance
–Designing robust quality
systems
–Ensure compliance to
relevant regulatory
requirements
–Ensure compliance to
requirements of Good
Manufacturing Practices
(GMP)
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54. Value addition in QA function
Value addition in QA function
Quality Assurance:
–Perform structured self-
inspection audits at regular
intervals to prevent any
failure or non-conformance
–Critically analyze the quality
non-conformance issues and
suggest corrective and
preventive actions
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55. Value addition in QA function
Quality Assurance:
–Perform documentation
audit to ensure realistic
recording of all the relevant
process parameters
–Review the adequacy of in-
process control checks to
prevent any potential
failures
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56. Value addition in QA function
Quality Assurance:
– Training & Knowledge Management
– Perform literature survey of FDA /
ICH / ISO guidelines, revisions in
the Pharmacopoeial specifications
and the current regulatory
requirements and provide training to
the production personnel.
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57. Value addition of Regulatory function to enhance Quality
Assurance
Regulatory Compliance:
–Knowledge of the current
international regulatory
requirements
–Comprehensive compilation of
the ‘Product Registration
Dossiers’ for the specific
customer countries
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60. National (India)
License Application Receipt
Manufacturing license Form No. 24 Form No. 25
Test license Form No. 30 Form No. 29
Import license Form No. 12 Form No.11
Compliance to (Drugs & Cosmetics Act 1940 & Rules under)
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Maharashtra College of Pharmacy, Nilanga
61. National (India)
Drug Regulatory
approval
Schedule Y Compliance
Form 44
Manufacturing Schedule M Compliance
Documentation Schedule U Compliance
Packaging Schedule P Compliance
API/Excipients/FP/PM IP Inputs if not BP/USP/ or IH
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62. Regional (US)
Parameters US
API USP (US DMF Type II)
Excipients USP
Packaging materials Complying to USP (Type III DMF)
Finished Product USP
Submission batch 1
Submission batch size 100,000 units or 1/10th of commercial batch
Stability Zone II requirement
25º+2ºC/60+5%RH & 40º+2ºC/75+5%RH
Reference product US RLD (Orange book listed)
Bioequivalence study Generally both fast & fed condition
Compliance to 21 CFR and its sub parts such as part 210 – 211, part 11,
part 314, part 350, ICH etc.,
Generic application FDA form 356h
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63. Regional (Europe)
Parameters Europe
API Ph.Eur. [COS (CEP) / EDMF]
Excipients Ph.Eur.
Packaging materials Ph.Eur.
Finished Product As per Ph.Eur. General requirement
Submission batch 2
Submission batch size 100,000 units or 1/10th of commercial batch
Stability Zone II requirement
25º+2ºC/60+5%RH & 40º+2ºC/75+5%RH
Reference Product Europe
Bioequivalence study Generally fasting condition
Compliance to Orange guide, EDQM, CHMP, CPMP guidelines, ICH
Generic application AS per Article 10 and its sub sections
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64. Regional (Others)
Parameters Other markets
API USP / Ph.Eur. (DMF requirement depends on the target
market)
Excipients USP / Ph.Eur.
Packaging materials USP / Ph.Eur.
Finished Product USP / Ph.Eur.
Submission batch 2 or 3
Submission batch size Depends on the target market
Stability Depends on the Target market (E.g.: ASEAN: Zone IVb)
Reference Product Depends on the Target market
Bioequivalence study Generally fasting condition
Compliance to Respective country guidelines
Generic application AS per respective country guidelines
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65. Global
Parameters Global
API Harmonization of specification
Excipients Harmonization of specification
Packaging materials Harmonization of specification
Finished Product Harmonization of specification
Submission batch 3
Submission batch size 100,000 units or 1/10th of commercial batch
Stability Zone III & IV
Reference Product Multiple region
Bioequivalence study Fasting & Fed condition
Compliance to Global Standards
Generic application AS per respective country guidelines
04th Oct. 2011 65
66. Regulatory Dossier
CTD dossier component
Module 1- Administrative & prescribing information (Region
specific)
Module 2: CTD summaries (Quality overall summary, the non-clinical
overview/summaries, clinical overviews/Summaries)
Module 3: Quality (CMC)
Module 4: Non clinical study reports (Documentation on
Toxicological and pharmacological tests)
Module 5: Clinical study reports (For Generics: Bioequivalence
study)
CTD ORGANIZATION IS BASED ON
M4: Organization of the CTD
M4E: The CTD — Efficacy
M4Q: The CTD — Quality
M4S: The CTD — Safety
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67. 04th Oct. 2011 67
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68. Regulatory Dossier
Regulatory approach:
Parameters US Europe Other markets India
API USP Ph.Eur. USP / Ph.Eur. IP
USDMF COS (CEP) / EDMF DMF requirement
depends on the
target market
Excipients USP Ph.Eur. USP / Ph.Eur. IP
Reference product US Europe Depends on the
target market
Indian (if not
available, then
US or Europe)
Packaging
materials
Complying to USP Ph.Eur. USP / Ph.Eur. IP
Finished product USP As per Ph.Eur.
General requirement
USP / Ph.Eur. IP
Submission batch 1 2 2 or 3 -
Submission batch
size
100,000 units or
1/10th of commercial
batch
100,000 units or
1/10th of
commercial batch
Depends on the
target market
No such
requirement
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69. Regulatory Dossier
Regulatory approach:
Parameters US Europe Other markets India
Stability data 1 batch 2 batches 2 or 3 batches 3 batches
Stability condition Zone I & II condition Zone I & II condition Depends on the
target market
Zone IV condition
Comparative
dissolution study
3 media 3 media Depends on the
target market
1 to 3 media
Input materials TSE/BSE, OVI
statements
TSE/BSE Depends on the
target market
No such requirement
Packaging materials Food grade certificate Food grade certificate Depends on the
target market
No such requirement
Method validation data As per ICH ICH ICH No such guideline
Process validation
data
Not required Not required Depends on the
target market
Not required for
submission
Bioequivalence study US reference product
under fast and fed
condition
European reference
product (generally
under fasting condition)
Generally fasting
bio study
Fasting bio study
Bioequivalence study In USFDA approved
CRO anywhere in the
world
MHRA/EU approved
CRO anywhere
Depends on the
target market
Indian study required
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70. Specific requirements of an US ANDA
QOS: in QbR format (Quality overall summary:Question-based review)
Exhibit batches (1 batch)
Stability data at the time of submission (3 Months)
TSE/BSE certificate (Transmissible spongiform encephalopatics/Bovine spongiform encephalopathy)
Structured Product Labeling (SPL) & side by side labeling comparison
OVI statement (Organic volatile impurities)
Financial certification / disclosure statement (Bioequivalence study)
Environmental assessment or claim for categorical exclusion
Declaration under Generic Drug Enforcement Act (Debarment certification & conviction statement)
Patent certification & exclusivity statement
Appointment of US agent & letter of US agent authorization
Copy of executed batch records
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71. Specific requirements of an EU dossier
Release testing in EU (QP)
Exhibit batches (2 batches)
Stability data (6 Months)
Process validation study
Release and shelf life specification
Microbiological considerations
TSE/BSE certificate
SPC (Summary of product characteristics)
Braille labeling (Just another way to read and write English)
Readability testing
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72. Regulatory Approval
Product Approval / Authorization
Successful registration of the product in the target market involves:
Successful review of API DMF / COS
Successful audit of API plant (wherever applicable)
Successful review of Drug Product Dossier (ANDA, MAA etc.)
• CMC data review
• Bioequivalence study data review
• Administrative data review
Successful audit of the drug product manufacturing plant
Successful audit of the bioequivalence study CRO
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73. Quality Assurance: Common Regulatory Compliance Issues
API
Infringing route of synthesis
Not consistent with respective Pharmacopoeial requirement
Impurity profile out of limit
Residual solvents not meeting the requirements
Unapproved site of manufacture (by concerned regulatory body)
Unacceptable physico-chemical properties (particle size, polymorphism, bulk
density, etc.)
From manufacturer who does not assure uninterrupted supply of API
Unapproved vendor (by drug product manufacturer)
Use of non DMF / COS material (e.g.: US, Europe etc.)
High cost (commercial viability)
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74. Excipient
Use of rarely available / or commonly not used excipients
Use of Non GRAS materials (Generally recognized as safe)
Incompatible
Not consistent with respective Pharmacopoeial requirement
Residual solvents not meeting the requirements
TSE / BSE / GMO (Genetically modified organisms)
Unapproved vendor
Unacceptable physico-chemical and functional properties (particle size,
bulk density, viscosity grade, surface area, degree of polymerization etc.)
From manufacturers who do not assure uninterrupted supply
High cost (commercial viability)
Quality Assurance: Common Regulatory Compliance Issues
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75. Formulation development
Pre-formulation
Improper API characterization
• Intrinsic solubility
• pH dependent solubility
• Saturation solubility
• Particle size
• Polymorph
• Bulk density
• Hygroscopicity study
• Impurity profile etc.,
Wrong choice of reference product (e.g. Not selecting innovator product)
Reference product not matching with the proposed market (e.g.: European
product selected for US market)
Inadequate drug excipient compatibility studies
Quality Assurance: Common Regulatory Compliance Issues
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76. Formulation development
Use of overages without proper justification
Use of banned / unapproved colours (in target market)
Use of excipients without proper justification (e.g.: surfactants etc.)
Use of excipients not consistent with the proposed route of administration
Use of Pharmacopoeial grade not consistent with the target market
Infringing process
Lack of proper development report
Inadequate optimization study data on process controls
Complex / costly process / lengthy operating cycle
Use of non-aqueous solvents (to be avoided)
Quality Assurance: Common Regulatory Compliance Issues
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77. Quality Assurance: Common Regulatory Compliance Issues
Formulation (Finished product)
Dissolution profile not matching with the reference product
Dissolution profile not matching with the bio strength in case of multi
strength products (for bio waiver purpose)
Not meeting Pharmacopoeial requirement
Dissolution – Lack of justification for selection of:
• Media
• Apparatus
• RPM
• Volume of media
• Sampling point
• Dissolution limit
• Justification for addition of surfactant (e.g.: SLS), enzymes (e.g.:
Pepsin, Pancreatin etc.) in the dissolution medium
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78. Quality Assurance: Common Regulatory Compliance Issues
Formulation (Finished product specification)
Not meeting Pharmacopoeial requirement / ICH Q6A
Lack of second identification test (for non specific test)
Inadequate impurities & residual solvent specification (ICH Q3A, B,
Q3C)
Lack of testing for preservatives, anti-oxidants wherever used
Lack of test for breakability / content uniformity for half tablets
(when functional score line exists)
Lack of test for establishing polymorphic conversions
Color identification test (e.g.: Europe)
Test for water content in solid dosage form (e.g.: US)
Missing of microbiological tests
Lack of specification for testing after reconstitution
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79. Quality Assurance: Common Regulatory Compliance Issues
Packaging Materials
Improper justification for the selection of packaging
materials
Lack of data on release / sorption / leaching study
(specially for those used in liquid / parenteral
preparations)
Lack of study to demonstrate integrity of container
closure system (where applicable)
Primary packaging material not suitable for its intended
performance (e.g.: child resistant)
Lack of identification test in the specification
Lack of food grade certification for the materials
Non use of virgin grade polymers
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80. Quality Assurance: Common Regulatory Compliance Issues
Manufacturing of submission batches
Inadequate batch size (e.g.: less than 100,000 units or 1/10th
of the commercial batch size whichever is higher)
Inadequate number of batches (e.g.: minimum 1 batch for
US, 2 batches for Europe etc.)
Inadequate packaging quantity (e.g.: minimum 100,000
units packed quantity for US)
Lack of process validation (applicable to many Asia Pacific
countries)
Lack of stratified sampling during in-process test (e.g.: US)
Hold time study
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81. Quality Assurance: Common Regulatory Compliance Issues
Analytical methods
Analytical methods not validated
Analytical methods not stability indicating (for stability
studies)
Forced degradation studies not performed
Inadequate justification for choice / selection of method
(UV vs HPLC)
Inadequate justification for selection of conditions
(column, wavelength, run time, mobile phase, flow rate,
temperature etc.)
Non availability of method development report
In adequate method validation parameters (e.g.: LOD,
LOQ in RS method)
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82. Quality Assurance: Common Regulatory Compliance Issues
Stability Study
Inadequate batch size (e.g.: less than 100,000 units or 1/10th
of the commercial batch size whichever is higher)
Inadequate number of batches (e.g.: minimum 1 batch for
US, 2 batches for Europe etc.)
Chamber temperature and humidity condition not appropriate
to the target market (e.g.: Zone I & II and Zone III and Zone
IV conditions are different)
Inadequate data at the time of submission (e.g.: 3 months
data for US, 6 months data for Europe)
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83. Quality Assurance: Common Regulatory Compliance Issues
Stability Study
Photo stability study not considered
Improper container orientation (specially for
liquid products)
Inadequate stability study on bulk shipment
pack (if intended to ship it for repackaging)
Inadequate parameters covered under stability
protocol (e.g.: microbial testing)
Not charging samples under fall back condition
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84. Stability
Global climatic zones
Zone
Mean Kinetic
Temperature (ºC)
Yearly average RH
(%)
Zone I (Moderate) 21 45
Zone II (Mediterranean) 25 60
Zone III (Hot & Dry) 30 35
Zone IV (Hot & humid) 30 70
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85. Stability
Distribution of nations into different climatic
zones:
Region Zones I & II Zone III & IV
European All countries -
American Chile, Canada, United States
Brazil, Jamaica,
Venezuela
Asian China, Japan, Turkey
India, Philippines, Sri
Lanka
African
South Africa, Zambia,
Zimbabwe
Botswana, Ghana,
Uganda
Australian / Oceanic Australia, New Zealand Fiji, Papua - New Guinea
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86. Quality Assurance: Common Regulatory Compliance Issues
Bioequivalence study
Use of wrong strength (in case of multiple strength products)
Use of inappropriate reference product (e.g.: US reference product
for Europe study)
Inadequate number of volunteers
Inadequate sampling intervals to capture tmax / cmax (maximum time
points should be there around the expected tmax/cmax)
Inadequate wash out period
Design fault in deciding what to test (e.g. testing of parent
compound or active metabolite or both)
Choice of study (Fast / Fed study or both)
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87. Quality Assurance: Common Regulatory Compliance Issues
Bioequivalence study
Use of non validated method for testing
Stability of plasma samples not established
Inadequate number of reserve samples (e.g.: 5 times of the sample
required for complete analysis)
Use of unapproved CRO
Inappropriate documentation [IEC / IRB approval of protocol, informed
consent, CRF, pharmacokinetic data, statistical data (SAS), etc]
Bioequivalence study sample formula different from commercial batch
formula
Bioequivalence study samples are not from GMP pivotal batch
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88. Quality Assurance: Common Regulatory Compliance Issues
Regulatory audits
Training of personnel
Facility upkeep
Equipment upkeep and preventive maintenance program
Area and environmental monitoring
QA systems, documentation control and traceability
Vendor approval procedure
Inventory control and storage
Change controls, deviations
OOS
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89. Quality Assurance: Common Regulatory Compliance Issues
Regulatory audits
Qualification / validation of system, facility, equipment etc.
Water system
HVAC system (Heating, ventilation and air conditioning)
Stability program
Process validation
Laboratory control, testing and release of materials
Documentation review (Batch records, analytical records, etc.)
Batch release by QA
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90. Quality Assurance in Life Cycle Management
Tasks to be performed
Pharmacovigilance
Safety reports
Post Approval Changes / Variations
To implement necessary up-dates and changes of the dossier
Line extensions (major changes, requiring new MAA)
To implement necessary up-dates and changes of the dossier
Renewal / Re-registration
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91. Quality Assurance in Life Cycle Management
Post Approval Changes
Formula
Batch size
Process
Site Change
Equipment Change
Source / Spec & test procedure
Multiple Changes
API / Excipients / Pkg Materials
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92. Quality Assurance in Life Cycle Management
Post approval changes Reporting
Level 1 Annual Report
Level 2
Changes Being Effected (CBE)
Changes Being Effected in 30 days (CBE-30)
Level 3
"Scale-Up and Post-Approval Changes"
Changes Being Effected (CBE)
Changes Being Effected in 30 days (CBE-30)
Prior Approval Supplement (PAS)
Post Approval Changes (US SUPAC)
SUPAC
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93. Quality Assurance in Life Cycle Management
Category Reporting
Minor Type 1A
Moderate Type 1B
Major Type II standard
Critical Type II complex
Post Approval Changes (Europe)
Variations
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94. Quality Assurance in Life Cycle Management
Other markets India
Notifications e.g. Australia
•Part A: Non-assessable changes
•Part B: Self-assessable changes
•Part C: Changes requiring approval
No such requirement
Post Approval Changes (Other markets)
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95. Quality Assurance in Life Cycle Management
Registration validity
US: Annual report every year
Europe: Re-registration once in 5 years
India: License renewal every 5 years
Other countries: Generally 5 years
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96. Quality Assurance: The most important element of regulatory
compliance
The most important element for compliance is…..
Manpower … Manpower … Manpower
It is the people who ensure Regulatory compliance at
every stage of product life cycle i.e. starting from
product development to life cycle management
The best way to enhance their capability is through …….
Training…….Training ……. Training
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97. Quality Assurance: The state of compliance
Everything is likely to undergo change during the life
cycle of a product…….
Formula, Process, Equipment, Batch size, Suppliers,
Manufacturing site, Trade dress, Indications,
Regulatory requirements, Specifications & test
procedures, People and so on ………
The only thing that can not be changed is the….
“State of Compliance”
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98. Regulatory Authorities
India: DCGI & State Drug Administration
European Union: EMEA and national
USA : Food and Drug Administration (FDA)
Australia : Therapeutic Goods Administration
Newzeland : Medsafe
South Africa: Medicines council control
Japan : Ministry of Health & Labour Welfare
Switzerland : Swissmedic
Brazil : ANVISA (The National Health Surveillance Agency)
Mexico: COFEPRIS (The Federal Commission for the Protection against Sanitary Risk)
Chile : ISP - Instituto de Salud Pública de Chile
Columbia: INVIMA – Instituto Nacional de Vigilancia de Medicamentos
Alimentos Carrera 68 D No. 17 - 11 / 21
Argentina: ANMAT - set in 1992 Argentine National Administration of
Drugs, Food & Medical Technology
France: Agence Française de Sécurité Sanitaire des Produits de Santé
Germany: Federal Institute for Drugs and Medical Devices
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