The document discusses key concepts and regulations regarding current good manufacturing practices (cGMP) for pharmaceuticals and medical devices. It covers cGMP principles of building quality in, having controls at every step, preventing contamination and mix-ups, documenting all activities. Key cGMP elements include qualified personnel, suitable facilities and equipment, controls over materials and processes, proper packaging and labeling, and laboratory controls. Regulations cover non-biologics, biologics, generics, devices, combination products, and investigational drugs. The quality system, facilities, materials, production, packaging/labeling and laboratory systems are also summarized.
The document provides an overview of key concepts in current good manufacturing practices (cGMP) for pharmaceuticals and medical devices. It discusses cGMP principles such as building quality into products through controls and preventing contamination. Key cGMP elements covered include facilities and equipment design, cleaning and sanitation programs, change control systems, process validation, and corrective and preventive action systems. The roles of quality control and quality assurance are defined. Regulations for drugs, devices, combination products, and investigational products are summarized. [END SUMMARY]
Six system management.pptx in pharmaceutical industryvinitnai
This document discusses the six system inspection model used by the FDA for drug manufacturing inspections. The six systems are: 1) production, 2) facilities and equipment, 3) laboratory controls, 4) materials, 5) packaging and labeling, and 6) quality management. Each system is described in detail, outlining the objectives, components inspected, and relevant FDA regulations. The six systems are interrelated and aim to ensure quality control at each stage of the drug manufacturing process from raw materials to finished product in compliance with cGMP.
This document discusses a six system inspection model for quality management in pharmaceutical manufacturing. It describes each of the six systems - quality system, production system, facilities and equipment system, laboratory control system, materials system, and packaging and labeling system. For each system, it outlines the key aspects and cites the relevant cGMP regulations. It emphasizes that the six systems are interrelated and must work together to ensure quality control and compliance with regulations. Regular self-inspections are also highlighted as an important part of pharmaceutical quality management.
The six-system inspection model is used to help pharmaceutical manufacturers comply with cGMP regulations. The six systems are: quality, production, facilities and equipment, laboratory controls, materials, and packaging and labeling. Each system has specific requirements under cGMP. The quality system involves establishing a quality management system. The production system requires defining, approving, and controlling quality and manufacturing processes. The facilities and equipment system designates clean and dirty areas with proper separation, protection, and environmental controls. The laboratory controls system ensures adequate and calibrated equipment for intended testing. The materials system controls materials receipt and storage. The packaging and labeling system validates master copies and controls changes.
Good Manufacture Practices Pharmaceutical technologyafsanamamedova
The document discusses Good Manufacturing Practices (GMP) which are a system for ensuring that products are consistently produced and controlled according to quality standards. It covers GMP guidelines from various organizations, key aspects of GMP like packaging and facilities, and concepts like quality assurance, quality control, documentation practices. GMP is important for minimizing risks in pharmaceutical production and ensuring medicine quality and safety. Adherence to GMP regulations is necessary for pharmaceutical manufacturers and exporters.
The document provides an overview of current good manufacturing practices (cGMP) and discusses their importance for ensuring quality and safety in drug production. It reviews cGMP requirements for different departments at the Blood Bank of Delmarva (BBD), including facilities, purchasing, donor services, quality control, IT, and more. Key points include establishing quality systems and procedures, controlling manufacturing processes, maintaining reliable testing, and generating detailed records to provide a complete history of work performed. Adhering to cGMP regulations helps assure the safety, purity and potency of blood products by building quality in at every stage of production.
The document summarizes key aspects of cGMP (current good manufacturing practices) regulations for pharmaceutical products as outlined in parts 210 and 211 of Title 21 of the Code of Federal Regulations. It discusses the responsibilities of quality control units in approving materials, facilities, equipment, processes, records and reports. Key duties of the quality control unit include approving or rejecting components, manufacturing procedures, specifications, drug products and investigating complaints. The quality control unit is meant to function independently to ensure products are made correctly and meet all necessary standards.
Principles of GMP Training Module ProgramLucky Saggi
Good manufacturing practices (GMP) are regulations and guidelines for ensuring that products are consistently produced and controlled according to quality standards. GMP covers all aspects of production from facilities and equipment to processes and quality control. Following GMP procedures is important for guaranteeing high quality, safe products and compliance with regulations. Regular audits help ensure ongoing adherence to GMP standards.
The document provides an overview of key concepts in current good manufacturing practices (cGMP) for pharmaceuticals and medical devices. It discusses cGMP principles such as building quality into products through controls and preventing contamination. Key cGMP elements covered include facilities and equipment design, cleaning and sanitation programs, change control systems, process validation, and corrective and preventive action systems. The roles of quality control and quality assurance are defined. Regulations for drugs, devices, combination products, and investigational products are summarized. [END SUMMARY]
Six system management.pptx in pharmaceutical industryvinitnai
This document discusses the six system inspection model used by the FDA for drug manufacturing inspections. The six systems are: 1) production, 2) facilities and equipment, 3) laboratory controls, 4) materials, 5) packaging and labeling, and 6) quality management. Each system is described in detail, outlining the objectives, components inspected, and relevant FDA regulations. The six systems are interrelated and aim to ensure quality control at each stage of the drug manufacturing process from raw materials to finished product in compliance with cGMP.
This document discusses a six system inspection model for quality management in pharmaceutical manufacturing. It describes each of the six systems - quality system, production system, facilities and equipment system, laboratory control system, materials system, and packaging and labeling system. For each system, it outlines the key aspects and cites the relevant cGMP regulations. It emphasizes that the six systems are interrelated and must work together to ensure quality control and compliance with regulations. Regular self-inspections are also highlighted as an important part of pharmaceutical quality management.
The six-system inspection model is used to help pharmaceutical manufacturers comply with cGMP regulations. The six systems are: quality, production, facilities and equipment, laboratory controls, materials, and packaging and labeling. Each system has specific requirements under cGMP. The quality system involves establishing a quality management system. The production system requires defining, approving, and controlling quality and manufacturing processes. The facilities and equipment system designates clean and dirty areas with proper separation, protection, and environmental controls. The laboratory controls system ensures adequate and calibrated equipment for intended testing. The materials system controls materials receipt and storage. The packaging and labeling system validates master copies and controls changes.
Good Manufacture Practices Pharmaceutical technologyafsanamamedova
The document discusses Good Manufacturing Practices (GMP) which are a system for ensuring that products are consistently produced and controlled according to quality standards. It covers GMP guidelines from various organizations, key aspects of GMP like packaging and facilities, and concepts like quality assurance, quality control, documentation practices. GMP is important for minimizing risks in pharmaceutical production and ensuring medicine quality and safety. Adherence to GMP regulations is necessary for pharmaceutical manufacturers and exporters.
The document provides an overview of current good manufacturing practices (cGMP) and discusses their importance for ensuring quality and safety in drug production. It reviews cGMP requirements for different departments at the Blood Bank of Delmarva (BBD), including facilities, purchasing, donor services, quality control, IT, and more. Key points include establishing quality systems and procedures, controlling manufacturing processes, maintaining reliable testing, and generating detailed records to provide a complete history of work performed. Adhering to cGMP regulations helps assure the safety, purity and potency of blood products by building quality in at every stage of production.
The document summarizes key aspects of cGMP (current good manufacturing practices) regulations for pharmaceutical products as outlined in parts 210 and 211 of Title 21 of the Code of Federal Regulations. It discusses the responsibilities of quality control units in approving materials, facilities, equipment, processes, records and reports. Key duties of the quality control unit include approving or rejecting components, manufacturing procedures, specifications, drug products and investigating complaints. The quality control unit is meant to function independently to ensure products are made correctly and meet all necessary standards.
Principles of GMP Training Module ProgramLucky Saggi
Good manufacturing practices (GMP) are regulations and guidelines for ensuring that products are consistently produced and controlled according to quality standards. GMP covers all aspects of production from facilities and equipment to processes and quality control. Following GMP procedures is important for guaranteeing high quality, safe products and compliance with regulations. Regular audits help ensure ongoing adherence to GMP standards.
The document discusses validation regulatory requirements from various authorities like the FDA, EU, WHO, and PIC/S. It outlines the objectives, historical background, and regulations for validation from these bodies. The three main stages of process validation are described as process design, process qualification, and continued process verification. Types of validation like prospective, concurrent, and retrospective are also defined.
c gmp (current good manufacturing practices)Rohit K.
cGMP (Current Good Manufacturing Practices) regulations provide the framework for ensuring quality control during pharmaceutical manufacturing. The regulations are divided into parts 210 and 211. Part 211 addresses good manufacturing practices for finished pharmaceuticals and is further divided into 11 subparts covering organization, facilities, equipment, production, packaging, labeling, quality control, and more. The goal of cGMP is to ensure identity, strength, quality and purity of drugs through strict control of manufacturing and monitoring.
The document summarizes current good manufacturing practices (cGMPs) for pharmaceutical manufacturing as regulated by the FDA. It discusses that cGMPs provide quality standards to ensure identity, strength, quality and purity of drugs. Key aspects of cGMPs covered include facilities and equipment design, production process controls, packaging and labeling, quality testing, and record keeping. Adherence to cGMPs helps assure proper design and monitoring of manufacturing to maintain compliance.
This document provides an overview of Good Manufacturing Practices (GMP) for pharmaceutical manufacturing. It defines GMP and explains that GMP aims to ensure consistent production of quality products through established processes and quality control. Key aspects of GMP covered include organization and personnel qualifications, facility and equipment design, material management, production operations, quality control testing, and documentation. Maintaining high standards of hygiene, sanitation, maintenance and training are emphasized. The goals of GMP are to minimize risks like contamination, incorrect dosing, and protect patient safety.
The document provides an overview of current good manufacturing practices (cGMP) requirements for pharmaceutical drugs as regulated by the U.S. Food and Drug Administration (FDA). It outlines the legal basis for cGMP in the Federal Food, Drug, and Cosmetic Act, key cGMP principles, and tools used by FDA to implement cGMP such as guidance documents and inspection programs. It also summarizes the main cGMP regulation covering finished pharmaceuticals and provides a high-level overview of cGMP requirements for facilities, equipment, components, production processes, packaging, laboratory controls, records, and returned/salvaged products. The document emphasizes that data and records must have integrity to ensure the reliability of information submitted to FDA.
the all the content in this profile is completed by the teachers, students as well as other health care peoples.
thank you, all the respected peoples, for giving the information to complete this presentation.
this information is free to use by anyone.
The document discusses six quality assurance systems for pharmaceutical manufacturers: quality management systems, production systems, facilities and equipment systems, materials management and quality control systems, documents and records systems, and management review and quality planning systems. It provides details on each system's objectives, requirements, and goals to ensure compliance with cGMP regulations. The production system section specifies requirements for batch tracking, process validation, verification of critical steps, and review of batch records. The facilities and equipment system outlines areas for separate clean and dirty operations and standards for building materials, air handling, and temperature control.
Process validation involves three key stages:
1) Process design to define the commercial manufacturing process based on development and scale-up.
2) Process qualification to evaluate the design and determine if reproducible commercial manufacturing is possible.
3) Continued process verification to ensure the process remains in control during routine production through monitoring and adjustment.
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.
The document provides an overview of process validation for pharmaceutical manufacturing. It defines validation as establishing documented evidence that a process will consistently produce a product meeting predetermined specifications. The objectives, types, and stages of validation are described. Key validation documentation like protocols, reports and master plans are summarized. Regulatory requirements for validation from agencies like FDA, EU, WHO and PIC/S are highlighted. The conclusion emphasizes that validation is critical for ensuring product quality and compliance.
The document discusses the requirements and procedures for conducting an Annual Product Quality Review (APQR). It states that APQRs are required by regulatory agencies to verify process consistency, assess trends, determine needed specification or production changes, and evaluate revalidation needs. They help ensure quality standards are met and facilitate communication between manufacturing, quality, and regulatory functions. The document outlines the responsibilities, key activities, data requirements, and documentation involved in properly conducting an APQR.
Six system inspection is a part of pharmaceutical.management system.this presentation gives the information about production, facilities and equipment, quality, laboratory,packaging and material system.
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.
The document discusses batch production record (BPR) review and release. It defines key terms like deviations, critical process parameters, critical quality attributes. It outlines regulatory requirements from ICH Q7, CFR 211, and consequences of non-compliance. The objectives of BPR review are to confirm the batch quality and was produced under control. Records of critical steps must be reviewed and approved by quality before release. Failure to comply with cGMPs can render a drug adulterated under the FDA act.
CGMP guidelines, CFR, CDER and CBER, PIC/S, Environment control in pharma industry, plant layout, maintenance of sterile area, Clean room classification, Environmental monitoring, Types of contaminants in pharma industry & Good Warehousing Practices.
Master of Good Manufacturing Practice - Course Detailsutspharmacy
Staff who hold postgraduate degrees in Good Manufacturing Practice (GMP) are essential for many pharmaceutical, biologic, medical device and food manufacturing companies.
This presentation provides an overview of the Master of Good Manufacturing Practice offered at the University of Technology, Sydney (UTS) in Australia. For more information visit www.gmp.uts.edu.au
This document discusses types of inspections, quality system approaches to GMP inspections, and the key elements of a quality system for pharmaceutical manufacturing. It covers internal and external inspections, pre-approval inspections, system-based inspections focusing on quality systems, facilities, equipment, utilities, materials, production, laboratory controls, packaging and labeling. Common regulatory observations and how to minimize risks of non-compliance are also summarized.
The document discusses FDA's quality system approach to cGMP regulations. It outlines six quality systems that FDA expects companies to have in place: quality, facilities and equipment, materials, production, laboratory, and packaging and labeling. The goal is to encourage a proactive, risk-based approach focused on critical processes to ensure product quality and safety.
The document discusses current good manufacturing practices (cGMPs) for biotechnology products. It explains that biotech products are produced from living cells and require strict production, storage, and manufacturing standards to remain effective and safe. The Food and Drug Administration approves biotech products and monitors manufacturers to ensure compliance with cGMPs. cGMPs establish industry-wide quality standards to protect consumers and help ensure consistent product quality. They address personnel, facilities, equipment, production processes, holding and distribution, and recordkeeping.
The Product Quality Review (PQR) is a regular review of all licensed medicinal products conducted to verify consistency of manufacturing processes and the appropriateness of specifications. The objectives of the PQR include determining the need for process, specification or validation changes; verifying compliance; identifying trends; and determining corrective actions. The EU requires annual PQRs that review areas like starting materials, process and product testing results, failed batches, deviations, changes made, and stability monitoring results. The PQR is intended to enhance quality and identify improvements.
The document discusses validation regulatory requirements from various authorities like the FDA, EU, WHO, and PIC/S. It outlines the objectives, historical background, and regulations for validation from these bodies. The three main stages of process validation are described as process design, process qualification, and continued process verification. Types of validation like prospective, concurrent, and retrospective are also defined.
c gmp (current good manufacturing practices)Rohit K.
cGMP (Current Good Manufacturing Practices) regulations provide the framework for ensuring quality control during pharmaceutical manufacturing. The regulations are divided into parts 210 and 211. Part 211 addresses good manufacturing practices for finished pharmaceuticals and is further divided into 11 subparts covering organization, facilities, equipment, production, packaging, labeling, quality control, and more. The goal of cGMP is to ensure identity, strength, quality and purity of drugs through strict control of manufacturing and monitoring.
The document summarizes current good manufacturing practices (cGMPs) for pharmaceutical manufacturing as regulated by the FDA. It discusses that cGMPs provide quality standards to ensure identity, strength, quality and purity of drugs. Key aspects of cGMPs covered include facilities and equipment design, production process controls, packaging and labeling, quality testing, and record keeping. Adherence to cGMPs helps assure proper design and monitoring of manufacturing to maintain compliance.
This document provides an overview of Good Manufacturing Practices (GMP) for pharmaceutical manufacturing. It defines GMP and explains that GMP aims to ensure consistent production of quality products through established processes and quality control. Key aspects of GMP covered include organization and personnel qualifications, facility and equipment design, material management, production operations, quality control testing, and documentation. Maintaining high standards of hygiene, sanitation, maintenance and training are emphasized. The goals of GMP are to minimize risks like contamination, incorrect dosing, and protect patient safety.
The document provides an overview of current good manufacturing practices (cGMP) requirements for pharmaceutical drugs as regulated by the U.S. Food and Drug Administration (FDA). It outlines the legal basis for cGMP in the Federal Food, Drug, and Cosmetic Act, key cGMP principles, and tools used by FDA to implement cGMP such as guidance documents and inspection programs. It also summarizes the main cGMP regulation covering finished pharmaceuticals and provides a high-level overview of cGMP requirements for facilities, equipment, components, production processes, packaging, laboratory controls, records, and returned/salvaged products. The document emphasizes that data and records must have integrity to ensure the reliability of information submitted to FDA.
the all the content in this profile is completed by the teachers, students as well as other health care peoples.
thank you, all the respected peoples, for giving the information to complete this presentation.
this information is free to use by anyone.
The document discusses six quality assurance systems for pharmaceutical manufacturers: quality management systems, production systems, facilities and equipment systems, materials management and quality control systems, documents and records systems, and management review and quality planning systems. It provides details on each system's objectives, requirements, and goals to ensure compliance with cGMP regulations. The production system section specifies requirements for batch tracking, process validation, verification of critical steps, and review of batch records. The facilities and equipment system outlines areas for separate clean and dirty operations and standards for building materials, air handling, and temperature control.
Process validation involves three key stages:
1) Process design to define the commercial manufacturing process based on development and scale-up.
2) Process qualification to evaluate the design and determine if reproducible commercial manufacturing is possible.
3) Continued process verification to ensure the process remains in control during routine production through monitoring and adjustment.
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.
The document provides an overview of process validation for pharmaceutical manufacturing. It defines validation as establishing documented evidence that a process will consistently produce a product meeting predetermined specifications. The objectives, types, and stages of validation are described. Key validation documentation like protocols, reports and master plans are summarized. Regulatory requirements for validation from agencies like FDA, EU, WHO and PIC/S are highlighted. The conclusion emphasizes that validation is critical for ensuring product quality and compliance.
The document discusses the requirements and procedures for conducting an Annual Product Quality Review (APQR). It states that APQRs are required by regulatory agencies to verify process consistency, assess trends, determine needed specification or production changes, and evaluate revalidation needs. They help ensure quality standards are met and facilitate communication between manufacturing, quality, and regulatory functions. The document outlines the responsibilities, key activities, data requirements, and documentation involved in properly conducting an APQR.
Six system inspection is a part of pharmaceutical.management system.this presentation gives the information about production, facilities and equipment, quality, laboratory,packaging and material system.
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.
The document discusses batch production record (BPR) review and release. It defines key terms like deviations, critical process parameters, critical quality attributes. It outlines regulatory requirements from ICH Q7, CFR 211, and consequences of non-compliance. The objectives of BPR review are to confirm the batch quality and was produced under control. Records of critical steps must be reviewed and approved by quality before release. Failure to comply with cGMPs can render a drug adulterated under the FDA act.
CGMP guidelines, CFR, CDER and CBER, PIC/S, Environment control in pharma industry, plant layout, maintenance of sterile area, Clean room classification, Environmental monitoring, Types of contaminants in pharma industry & Good Warehousing Practices.
Master of Good Manufacturing Practice - Course Detailsutspharmacy
Staff who hold postgraduate degrees in Good Manufacturing Practice (GMP) are essential for many pharmaceutical, biologic, medical device and food manufacturing companies.
This presentation provides an overview of the Master of Good Manufacturing Practice offered at the University of Technology, Sydney (UTS) in Australia. For more information visit www.gmp.uts.edu.au
This document discusses types of inspections, quality system approaches to GMP inspections, and the key elements of a quality system for pharmaceutical manufacturing. It covers internal and external inspections, pre-approval inspections, system-based inspections focusing on quality systems, facilities, equipment, utilities, materials, production, laboratory controls, packaging and labeling. Common regulatory observations and how to minimize risks of non-compliance are also summarized.
The document discusses FDA's quality system approach to cGMP regulations. It outlines six quality systems that FDA expects companies to have in place: quality, facilities and equipment, materials, production, laboratory, and packaging and labeling. The goal is to encourage a proactive, risk-based approach focused on critical processes to ensure product quality and safety.
The document discusses current good manufacturing practices (cGMPs) for biotechnology products. It explains that biotech products are produced from living cells and require strict production, storage, and manufacturing standards to remain effective and safe. The Food and Drug Administration approves biotech products and monitors manufacturers to ensure compliance with cGMPs. cGMPs establish industry-wide quality standards to protect consumers and help ensure consistent product quality. They address personnel, facilities, equipment, production processes, holding and distribution, and recordkeeping.
The Product Quality Review (PQR) is a regular review of all licensed medicinal products conducted to verify consistency of manufacturing processes and the appropriateness of specifications. The objectives of the PQR include determining the need for process, specification or validation changes; verifying compliance; identifying trends; and determining corrective actions. The EU requires annual PQRs that review areas like starting materials, process and product testing results, failed batches, deviations, changes made, and stability monitoring results. The PQR is intended to enhance quality and identify improvements.
MRA201 T. Unit 1 Regulatory aspects of drugs and cosmetics unit 1.pptxDimple Marathe
organization, structure, function of FDA, FR, CFR, FFDCA, Approval process of IND, NDA, ANDA, orphan drug, combination product, changes to approved NDA, ANDA, packaging labelling of pharmaceutical.
Unit 1 - Clinical Trial Protocol. Clinical research Regulation.pptxDimple Marathe
This document summarizes key aspects of clinical trial protocols based on clinical research regulations. It defines a protocol as carefully designed to answer study questions and objectives in a scientifically sound manner, with potential benefits outweighing risks. A protocol provides background, rationale and objectives for a research project, and describes its design, methodology, ethical considerations and organization. It should include inclusion/exclusion criteria, treatment information, safety monitoring plans, statistical analysis methods, informed consent processes, and allow for monitoring and audits. Research involving humans must be scientifically justified and described clearly in the protocol.
Unit 1 Part 1Drug Development Process - Part 1.pptxDimple Marathe
This document summarizes clinical research regulations and the drug development process. It defines clinical trials as organized studies that investigate new methods of preventing, diagnosing or treating disease in human subjects. The purpose of clinical trials is to generate safety and efficacy data for new drugs. The drug development process takes compounds through pre-clinical animal testing and four phases of clinical trials in humans to determine safety, effectiveness and side effects before regulatory approval and marketing. Success rates are low, with only about 1 in 5,000 compounds entering trials ultimately being approved.
Unit 1 - Part 2 Drug Development Process - Part 2.pptxDimple Marathe
The document summarizes the clinical research regulations and drug development process. It discusses that developing new drugs is an expensive, time-consuming, and cumbersome process that involves targeting diseases, conducting animal studies to test safety and side effects, and submitting investigational new drug applications to the FDA. The development process also includes multiple phases of clinical trials on humans to further test safety and efficacy.
Phases of Clinical Trials. Clinical Research RegulationDimple Marathe
This document outlines the 5 phases of clinical trials:
Phase 0 involves microdosing of drug candidates to gather preliminary pharmacokinetic data.
Phase I studies test drug safety in healthy volunteers or limited patient groups.
Phase II explores efficacy in patients to determine optimal dosing for Phase III.
Phase III expands trials to hundreds/thousands of patients to confirm safety and efficacy.
Phase IV occurs after approval to study long-term effects, safety, or effectiveness of other combinations.
CGMP drug regulatory affairs Current good manufacturing practicesDimple Marathe
Current Good Manufacturing Practices (CGMPs) are the minimum standard that a manufacturer must meet in their production processes and quality systems to ensure a product is safe for its intended use. CGMPs help provide assurance that a product meets the requirements for identity, strength, quality, purity and is free from contamination. Manufacturers must follow detailed rules and guidelines on the equipment, facilities, production, packaging, testing, and record keeping that are required by regulatory agencies like the FDA.
Upld narcotics and psychotropic dimple marathe.pptxDimple Marathe
This document discusses the Narcotics Drugs and Psychotropic Substances Act. The Act regulates narcotic drugs and psychotropic substances, and aims to prevent their misuse and trafficking. It outlines rules for production, manufacture, possession, sale, purchase, transport, warehousing, consumption and inter-state movement of regulated substances.
Upld Labelling requirement & label claim for dietary supplements.pptxDimple Marathe
This document discusses labeling requirements and claims for dietary supplements in the United States. It outlines that labels must include the product name, ingredients and quantities, supplement facts, and contact information. Labels can make health claims describing a nutrient-disease link if FDA-approved, nutrient content claims comparing nutrient levels, and structure/function claims about a supplement's role in the body with a disclaimer. The Recommended Daily Allowance provides average daily nutrient intake levels for a healthy population. Federal agencies like the FDA and FTC regulate labeling to ensure accurate information for consumers.
Blood and Blood product regulation in indiaDimple Marathe
This document discusses regulations for blood and blood products in India. It covers the national blood policy, regulations under the Drugs and Cosmetics Act, and general requirements for blood banks. The national blood policy aims to provide safe blood and blood products through non-remunerated donors. Regulations specify that human blood is a drug and blood banks must follow good manufacturing practices. Requirements for blood banks include the facility location, storage areas, health of personnel, and waste disposal procedures.
Muktapishti is a traditional Ayurvedic preparation made from Shoditha Mukta (Purified Pearl), is believed to help regulate thyroid function and reduce symptoms of hyperthyroidism due to its cooling and balancing properties. Clinical evidence on its efficacy remains limited, necessitating further research to validate its therapeutic benefits.
Here is the updated list of Top Best Ayurvedic medicine for Gas and Indigestion and those are Gas-O-Go Syp for Dyspepsia | Lavizyme Syrup for Acidity | Yumzyme Hepatoprotective Capsules etc
Osteoporosis - Definition , Evaluation and Management .pdfJim Jacob Roy
Osteoporosis is an increasing cause of morbidity among the elderly.
In this document , a brief outline of osteoporosis is given , including the risk factors of osteoporosis fractures , the indications for testing bone mineral density and the management of osteoporosis
Local Advanced Lung Cancer: Artificial Intelligence, Synergetics, Complex Sys...Oleg Kshivets
Overall life span (LS) was 1671.7±1721.6 days and cumulative 5YS reached 62.4%, 10 years – 50.4%, 20 years – 44.6%. 94 LCP lived more than 5 years without cancer (LS=2958.6±1723.6 days), 22 – more than 10 years (LS=5571±1841.8 days). 67 LCP died because of LC (LS=471.9±344 days). AT significantly improved 5YS (68% vs. 53.7%) (P=0.028 by log-rank test). Cox modeling displayed that 5YS of LCP significantly depended on: N0-N12, T3-4, blood cell circuit, cell ratio factors (ratio between cancer cells-CC and blood cells subpopulations), LC cell dynamics, recalcification time, heparin tolerance, prothrombin index, protein, AT, procedure type (P=0.000-0.031). Neural networks, genetic algorithm selection and bootstrap simulation revealed relationships between 5YS and N0-12 (rank=1), thrombocytes/CC (rank=2), segmented neutrophils/CC (3), eosinophils/CC (4), erythrocytes/CC (5), healthy cells/CC (6), lymphocytes/CC (7), stick neutrophils/CC (8), leucocytes/CC (9), monocytes/CC (10). Correct prediction of 5YS was 100% by neural networks computing (error=0.000; area under ROC curve=1.0).
These lecture slides, by Dr Sidra Arshad, offer a quick overview of the physiological basis of a normal electrocardiogram.
Learning objectives:
1. Define an electrocardiogram (ECG) and electrocardiography
2. Describe how dipoles generated by the heart produce the waveforms of the ECG
3. Describe the components of a normal electrocardiogram of a typical bipolar lead (limb II)
4. Differentiate between intervals and segments
5. Enlist some common indications for obtaining an ECG
6. Describe the flow of current around the heart during the cardiac cycle
7. Discuss the placement and polarity of the leads of electrocardiograph
8. Describe the normal electrocardiograms recorded from the limb leads and explain the physiological basis of the different records that are obtained
9. Define mean electrical vector (axis) of the heart and give the normal range
10. Define the mean QRS vector
11. Describe the axes of leads (hexagonal reference system)
12. Comprehend the vectorial analysis of the normal ECG
13. Determine the mean electrical axis of the ventricular QRS and appreciate the mean axis deviation
14. Explain the concepts of current of injury, J point, and their significance
Study Resources:
1. Chapter 11, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 9, Human Physiology - From Cells to Systems, Lauralee Sherwood, 9th edition
3. Chapter 29, Ganong’s Review of Medical Physiology, 26th edition
4. Electrocardiogram, StatPearls - https://www.ncbi.nlm.nih.gov/books/NBK549803/
5. ECG in Medical Practice by ABM Abdullah, 4th edition
6. Chapter 3, Cardiology Explained, https://www.ncbi.nlm.nih.gov/books/NBK2214/
7. ECG Basics, http://www.nataliescasebook.com/tag/e-c-g-basics
Rasamanikya is a excellent preparation in the field of Rasashastra, it is used in various Kushtha Roga, Shwasa, Vicharchika, Bhagandara, Vatarakta, and Phiranga Roga. In this article Preparation& Comparative analytical profile for both Formulationon i.e Rasamanikya prepared by Kushmanda swarasa & Churnodhaka Shodita Haratala. The study aims to provide insights into the comparative efficacy and analytical aspects of these formulations for enhanced therapeutic outcomes.
1. IF IT WAS NOT DOCUMENTED, THEN IT WAS NOT DONE”
Fundamentals of US Regulatory Affairs
Chapter 8
Sanjivani College of pharmaceutical education and research, Kopargaon
2. Objectives
• Understanding GMP
• Understanding basic quality system concepts
and quality system regulations
• Overview of key GMP regulations
• Differences and similarities between
pharmaceuticals and medical devices
• Concept of clean design and process
validation
3. Objectives (cont)
• Basic elements of sanitary equipment design
• Effective cleaning and sanitation programs
• CAPA system (Corrective And Preventative
Action)
• Cross-contamination risk within the
manufacturing environment
4. cGMP
(Current Good Manufacturing Practice)
• GMP should be “Designed” to be flexible to allow each
manufacturer to decide individually how to implement
the necessary controls by using scientific sound design,
processing methods and testing procedures
• The “C” in GMP means current – up to date
technologies
• Overall concept
– Quality should be built into the product
– Testing alone cannot be relied on to ensure product quality
• A product that is ‘fit for its purpose”
5. cGMP Principles
• Build QUALITY in - you cannot test or inspect
quality in to a product – it must first be quality
• Have controls in place for each step of the
process – increase the likelihood the product
produced in safe and fit for its intended
purpose
• Product the product from contamination and
cross-contamination and prevent mix-ups.
6. cGMP Principles (cont)
• Know what you are doing in advance and
document what really happened (document
everything)
• Work towards consistency and control and
monitor your system
• Have an independent Quality Assurance
Group
7. GMP is global
• It is influenced by international bodies
– ICH
– International Organization for Standardization
(ISO)
– cGMP Harmonization Analysis working group (FDA
2003) Modify 21CFR210 and 211 to meet ICH
8. GMP Regulations
• Non-biologics – FD&C Act section 501(a)(2)(b)
• Finished Pharmaceuticals – 21CFR211 – Clinical supply
dosage forms (including placebo) and commercially marketed dosage form
• ICH Q7A GMP for Active Pharmaceutical Ingredients
• Biologic Drug Products – 21CFR 210 and 211; 21CFR 600-680;
comply with BLA commitments and applicable standards
• Quality Systems - ISO9000, non-US Pharmaceutical
quality management requirements FDA Quality
Requirement System (QRS)
• Guidances and CPGM (Compliance Program Guidance Manuals) –
for FDA GMP inspections – details cleaning validation, water systems,
microbiological and QC labs, sterile bulk substance
9. cGMP Requirements
(as many regulations as GCP)
• A Quality System (change control, validation,
CAPA
• Qualified and trained personnel
• Fit for use buildings and facilities to meet the
purpose
• Equipment that is suitable, clean, maintained
and calibrated
10. cGMP Requirements (cont)
• Controls in place to prevent degradation or
contamination of materials (raw, in process
and final)
• Production and in-process controls for
performance monitoring and deviations
• Proper packaging and labeling – ID and
Protection
• Laboratory controls – specifications , samples,
testing
11. Generic Drugs and GMP
• Is identical or bioequivalent to a brand-name
drug in dosage form, safety, strength, route of
administration, quality, performance
characteristics and intended use
• Analytical testing of the chemical composition
of the generic is determined to be the same as
the branded product
12. Medical Devices
• FD&C Section 501(h) and 520(f)(1)
– Amended in 1976 - Medical Device Amendment
– 1978- Device GMP initiated
– 1996 – Revised ‘Quality System Regulations’
• Human factors techniques and data should be integral
considerations in all medical device design control
components
• Each manufacturer must establish and maintain procedures
for verifying the design input
• Design validation must ensure devices conform to defined
user needs and intended users and must include testing of
production units under actual or simulated use conditions
• Design validation must include risk analysis and use error
13. Combination Products
• Utilize the capabilities of two or more
different product types to provide effective
health care (21CFR3.2(c)) and cGMP (21CFR
Part4 Subpart A)
• The drugs and devices are still covered by
individual regulations (21CFR210 and 211;
21CFR810 respectively)
14. cGMP for Phase 1 Investigational Drugs
• Guidance for Industry: Current GMP Practice for
Phase 1 Investigational Drugs (July 2008)
• 21CFR201.2 – If the Phase 1 drug is already
marketed or used in Phase 2 or 3 trials, then it is
exempt from 21CFR211
• Trial Materials need
– Well-defined and written procedures
– Adequately controlled equipment and manufacturing
environment
– Accurately and consistently recorded data
15. cGMP for Phase 2 and Phase 3 Investigational Drugs
• Guidance: Preparation of Investigational New
Drug Products (1991)
16. Adulterated Drugs or Devices
• A drug or device is considered adulterated unless
it is manufactured in conformity with cGMP
practices (newest industry standards)
• A robust quality system is required to provide the
necessary framework for implementing Quality
by Design, continuous improvement and risk
management
• Whether documented on paper or electronic all
data must be able to be traced back to the source
and verified
17. Device Quality System Regulation (QSR)
• Quality System is the organizational structure,
responsibilities, procedures, processes and
resources for implementing process management
– Medical devices QSR are found in 21CFR820
– ICH Pharmaceutical Quality System Q10
• QSR states specific requiremnts for such key
elements as management responsibility, quality
planning, CAPA, design controls and purchasing
control
18. Corrective And Preventive Action
(CAPA)
• Each Device manufacturer must maintain history
files, a device ,aster record and a device history
record for each type of device
• Every company must have quality plans and
quality system records that define its quality
practices
• Device Manufactures are required to establish
purchasing controls and institute post-
distribution device failure investigations and
CAPA for defects or recurring technical problems
19. Pharmaceutical Quality System
• Guidance for Industry: Quality Systems Approach to Pharmaceutical
cGMP Regulations (June 2006); 21CFR210 and 211
• The six-system inspection model
– Quality system
– Facilities and equipment system
– Materials system
– Production system
– Packaging and labeling system
– Laboratory controls
• Robust Quality System will have
– SPOs
– Training
– Records and good documentation practive
20. QC vs. QA
Quality Control vs. Quality Assurance
• The QC unit monitors overall compliance with
cGMPs
• The QA units supplies oversight by auditing
the functions
• They identify and investigate OOS (Out-of-
Specification) results, deviations and failures
in both production and the analytical
laboratory.
21. Facilities and Equipment System
• Areas are designated as clean and dirty,
– Physical separation, equipment and staff for each
operation
• Specify personnel protection equipment and to
prevent contamination by humans
• Areas must operate to a single standard - GMP or
non-GMP
• Need to have designed into areas
– Building materials, air handling, temperature,
microbiology
22. Records
• Distribution records must be maintained to
aid in recalls
• Environmental Controls, Support systems,
Alerts, Action Limits must be established
• The environment must be controlled and
monitored to prevent product cross-
contamination and contamination by harmful
microorganisms or extraneous matter (filth)
23. Microbiology
• Effects on product
– Causing human illness
– Product
• Discoloration
• Malodors
• Production of gasses that can lead to package swelling or busting
• Breakdown in viscosity or elasticity
• Otherwise unable to perform as intended
• Types: contact or airborne/ bacterial, yeast or mold
• Resistance to product preservative system or sanitizers
(think antibiotic resistance)
• Classic Microbiology – takes 48-72 h for aerobic bacteria;
72-120 h for yeast or mold
24. Microbiology – areas of risk
• Heat exchangers
• Air compressors
• Pumps
• Water systems (Grades of water – WFI)
• Valves
• Ancillary Equipment (O-rings, pipes, clamps, gaskets
• Effective Cleaning and Sanitation (C&S)
– Autoclaves, sanitizer, alcohol, steam generators
– CIP – Conducted on assembled equipment
– COP – Conducted on dissembled equipment
25. Material System
• The measurement and activities to control
finished products, components containers and
closures
– Inventory Control Process
– Drug Storage
– Distribution Controls and Records
• Written procedures for the receipt, storage,
testing and approval or disapproval of raw
materials components, products, containers and
closures
26. Production System
• Quality and manufacturing process and
procedures (and changes to them) must be
defined, approved and controlled.
• Batch numbering and maintaining proper
traceability is required
– Track batch, equipment use records and labeling used,
personnel, raw material controls are traceable
• Verification of all steps including sign-off are
required for critical process steps.
• All batch records must be reviewed na d have QA
approval before the product is released
27. Package and Labeling System
• FDA ‘recommends’ as part of the design process
and before commercial products that the controls
for all processes within the packaging and
labeling systems be planned and documented
with written procedures.
– Discriminating features of different
products/strengths
– Distribution of all labels to manufacturing unit
– Reconciliation is performed between label issued,
applied and returned (damaged) to insure 100%
accountability
28. Laboratory Control system
• Laboratory Controls and written documentation
– Analytical Methods validation and laboratory
equipment qualification
– Scientifically sound stability program to support
labeled expiration dating
– Sampling program Statistical models to determine
sample scheme
– Proper training of QC staff to collect samples
• Batch, water, microbiology, etc.
– Retesting conditions
29. Critical Elements of Subsystems
• SOPs
– Describes how the company complies with the
drug or device regulations and are critical to GMP
compliance
– See GLP review on overall view of SOPs
– Change Control System – to prevent unintended
consequences to product quality
– Training
– Records
30. Verification, Qualification and Validation
apply to both Drugs and Devices
• All operational methodologies and procedures
utilized in manufacturing and testing be validated
to demonstrate they can function as intended
• Validation activities must be conducted I
accordance with approved protocols and
appropriate guidances
• Process validation ensures that product quality,
safety and effectiveness are designed and built
into the final product (batch to batch output
uniformity)
31. Process Validation
• Guidance for Industry: Process Validation: General Principles
and Practices (January 2011)
– Stage 1 – Process Design: The commercial process is based on
knowledge gained through development and scale-up activities
– Stage 2 – Process Qualification: The process qualification is
confirmed as being capable of reproducible commercial
manufacturing
– Stage 3 – Continued Process Verification: Ongoing assurance that
the process remains in a state of control during routine
production. Requires an ongoing program to collect and analyze
product and process data that relate to product quality
(21CFR211.180(e))
• Requires an interdisciplinary team approach (process engineering,
industrial pharmacy, analytical chemistry, microbiology, statistics
• “Begin with the end in mind”
32. Method Validation
• Draft Guidance for Industry: Analytical
Procedures and Methods Validation – Chemistry
Manufacturing and Controls Documentation
(August 2000)
• Generics - USP
• Each method used to analyze the drug or biologic
must have associated validation to support the
documentation of drug substance, product
identity, strength, purity, and potency