PIC/S is a combine term used for the execution of activities of Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme
harmonize, educate, and update aspects relating to Good Manufacturing Practice among member countries
harmonized relation among regulatory authorities and governments
members
history
role
objective and function
guidlines
“A GMP is a system for ensuring that products are consistently produced and controlled according to quality standards. It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product”.
GMP is important to ensure that businesses produce safe food to the public. Businesses in the food industry have a legal and moral responsibility to prepare food that is safe for the consumer. By not implementing adequate good manufacturing practices (GMP), a food business can risk several negative consequences.
The implemented of GMP on food and medicine industry's.
Most of the time it has been seen that the GMP content of the food industry related is very low so we have make a little effort. This makes will content available to students easily.
I. This document outlines the key aspects of Good Manufacturing Practices (GMP) and cGMP, including a timeline of GMP development, requirements for personnel, premises, equipment, standard operating procedures, validation processes, and documentation such as batch records.
II. It defines GMP as ensuring consistent and controlled production of products according to quality standards. cGMP requirements include qualified personnel, designed facilities and equipment, and documented procedures for manufacturing, testing, and record keeping.
III. The document provides details on specific GMP rules for premises, equipment, personnel, operations, warehousing, validation, and labeling. Adherence to GMP aims to minimize errors and ensure uniform, high quality batches of pharmaceutical products.
The document discusses form fill and seal (FFS) or blow fill seal (BFS) technology used in pharmaceutical packaging. BFS is a process where plastic containers are formed, filled with sterile product, and sealed in a single integrated machine within a sterile environment. It has become a prevalent aseptic processing technique over the last 20 years. The basic BFS process involves extruding a plastic tube, molding it into a container within the mold, filling the container, sealing it, and discharging the finished package. It reduces personnel and validation requirements compared to traditional packaging. While it has advantages like reduced costs, it also has challenges like particulate and temperature control that require mitigation strategies.
This document provides definitions and descriptions related to Good Manufacturing Practices (GMP) regulations for pharmaceutical manufacturing. It defines key terms like active pharmaceutical ingredient, batch, and validation. It describes GMP requirements for facilities, equipment, documentation, personnel training, hygiene practices, and prevention of cross-contamination. The goal of GMP is to ensure manufactured products are safe, pure and effective.
GMP regulations provide minimum standards for pharmaceutical manufacturing to ensure consistent high quality, safety, and efficacy of medicines. Key aspects of GMP include having documented procedures, validated processes, qualified facilities and equipment, trained personnel, cleaning and maintenance programs, quality control testing, and compliance auditing. Following GMP helps manufacturers produce pharmaceuticals that meet marketing authorizations and protects public health.
PIC/S is a combine term used for the execution of activities of Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme
harmonize, educate, and update aspects relating to Good Manufacturing Practice among member countries
harmonized relation among regulatory authorities and governments
members
history
role
objective and function
guidlines
“A GMP is a system for ensuring that products are consistently produced and controlled according to quality standards. It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product”.
GMP is important to ensure that businesses produce safe food to the public. Businesses in the food industry have a legal and moral responsibility to prepare food that is safe for the consumer. By not implementing adequate good manufacturing practices (GMP), a food business can risk several negative consequences.
The implemented of GMP on food and medicine industry's.
Most of the time it has been seen that the GMP content of the food industry related is very low so we have make a little effort. This makes will content available to students easily.
I. This document outlines the key aspects of Good Manufacturing Practices (GMP) and cGMP, including a timeline of GMP development, requirements for personnel, premises, equipment, standard operating procedures, validation processes, and documentation such as batch records.
II. It defines GMP as ensuring consistent and controlled production of products according to quality standards. cGMP requirements include qualified personnel, designed facilities and equipment, and documented procedures for manufacturing, testing, and record keeping.
III. The document provides details on specific GMP rules for premises, equipment, personnel, operations, warehousing, validation, and labeling. Adherence to GMP aims to minimize errors and ensure uniform, high quality batches of pharmaceutical products.
The document discusses form fill and seal (FFS) or blow fill seal (BFS) technology used in pharmaceutical packaging. BFS is a process where plastic containers are formed, filled with sterile product, and sealed in a single integrated machine within a sterile environment. It has become a prevalent aseptic processing technique over the last 20 years. The basic BFS process involves extruding a plastic tube, molding it into a container within the mold, filling the container, sealing it, and discharging the finished package. It reduces personnel and validation requirements compared to traditional packaging. While it has advantages like reduced costs, it also has challenges like particulate and temperature control that require mitigation strategies.
This document provides definitions and descriptions related to Good Manufacturing Practices (GMP) regulations for pharmaceutical manufacturing. It defines key terms like active pharmaceutical ingredient, batch, and validation. It describes GMP requirements for facilities, equipment, documentation, personnel training, hygiene practices, and prevention of cross-contamination. The goal of GMP is to ensure manufactured products are safe, pure and effective.
GMP regulations provide minimum standards for pharmaceutical manufacturing to ensure consistent high quality, safety, and efficacy of medicines. Key aspects of GMP include having documented procedures, validated processes, qualified facilities and equipment, trained personnel, cleaning and maintenance programs, quality control testing, and compliance auditing. Following GMP helps manufacturers produce pharmaceuticals that meet marketing authorizations and protects public health.
Quality assurance and good manufacturing practices are important to ensure drug quality and safety. Quality assurance covers all factors that influence a product's quality and requires adequate resources. Good manufacturing practices provide quality standards for production and controls to ensure products meet their intended use as required by regulations. Key elements of good manufacturing practices include facilities, equipment, documentation, materials management, production controls, packaging and labeling, storage, and validation. While GMPs vary between countries, the overall goals are similar in requiring design and maintenance standards, standard operating procedures, quality control, trained personnel, and management oversight.
This document discusses Good Manufacturing Practices (GMP) and current Good Manufacturing Practices (cGMP). It provides definitions of GMP and cGMP, explaining that GMP ensures quality and safety in manufacturing while cGMP refers specifically to FDA regulations. The principles and regulations of GMP, cGMP, and their comparison are outlined. Key aspects like facilities, equipment, documentation, packaging and labeling, quality control, and standard operating procedures are summarized.
In this slide contains introduction, qualification, preventive maintenance, requalification method.
Presented by: Malarvannan M (Department of pharmaceutical analysis).RIPER, anantapur
Cleaning validation is important to ensure safety and prevent contamination during pharmaceutical production. It involves collecting data to prove cleaning procedures consistently remove residues to acceptable limits. Key aspects of validation include defining cleaning procedures, acceptance criteria, sampling methods, and analytical techniques. Validation should continue if procedures or products change. Overall, cleaning validation demonstrates equipment is suitably cleaned between batches to maintain quality as required by cGMP regulations.
The document outlines good manufacturing practices (GMP) that must be followed to produce safe products. It discusses personnel hygiene practices, facility requirements, storage practices, process equipment guidelines, cleaning and sanitation procedures, pest control measures, and documentation standards that are necessary to ensure product quality and safety.
This document outlines Good Manufacturing Practices (GMP) for producing sterile pharmaceutical products. It discusses that GMP ensures products are consistently manufactured and controlled to quality standards for their intended use. Specific requirements are provided for facilities, equipment, environmental controls, personnel hygiene and sanitation practices when manufacturing sterile injectables, ophthalmic preparations and other sterile products to minimize risks of contamination. Production must follow documented procedures and strict aseptic techniques to ensure the sterility and quality of manufactured medicines.
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.
This document provides an overview of good manufacturing practices (GMP) in the pharmaceutical industry. It begins with definitions of GMP and discusses its early history starting in the 1900s with no regulations. Key events that led to increased regulation include Upton Sinclair's 1905 book The Jungle exposing unsanitary meat plants and the 1906 Pure Food and Drug Act. The document then outlines the timeline of major GMP regulations from 1902 to the present. It provides details on key areas covered by GMP including personnel, premises, equipment, process validation, and quality assurance.
Good Warehousing Practices (GWH) in Pharmaceutical IndustrySwapnil Karale
Mr. Swapnil Karale has over 10 years of experience in the pharmaceutical industry and is qualified as a cGMP auditor. He has expertise in quality assurance, auditing, validation, calibration and training. The presentation covers good warehousing practices, including premises, security, temperature and humidity control, equipment, personnel, sanitation, receipt and storage of goods, packing for transportation, and transportation. Maintaining proper documentation of all warehousing activities is emphasized.
This document discusses cross-contamination, mix-ups, and clean room practices. It defines key terms like contamination, cross-contamination, and mix-ups. It identifies sources of contamination like personnel, equipment, airflow, and discusses prevention methods like facility design, cleaning validation, and cleanroom classification systems. Personnel clothing, hygiene, and cleaning practices are important to prevent contamination from people. Proper airflow and HVAC systems also help control contamination. Regular monitoring and maintenance of cleanrooms is necessary to ensure quality manufacturing of pharmaceutical products.
The document discusses the selection criteria for container closure systems for pharmaceutical products. There are four main criteria: 1) Protection - the container closure must protect the drug from factors like light, oxygen, and moisture that could degrade it. 2) Compatibility - the container and drug must not interact in ways that could affect drug stability or safety. 3) Safety - the materials used cannot leach harmful substances that the patient could be exposed to. 4) Performance - the container closure must function properly to deliver the drug as intended and support compliance. Compatibility testing, extraction studies, and functionality tests help evaluate different container closure systems.
10 Principles of Good Manufacturing Practice (GMP)Arrelic
The document discusses the 10 principles of Good Manufacturing Practice (GMP). It explains that GMP establishes minimum standards for manufacturing products to prevent issues like contamination. Following the 10 principles can help make GMP a lifestyle at companies. The principles include having written procedures, carefully following procedures, documenting work, validating systems, facility and equipment design, maintaining facilities/equipment, job competence, cleanliness, controlling processes, and conducting audits. The document provides details on each principle and how following them helps ensure quality, compliance and safety.
This document provides an introduction to Good Laboratory Practices (GLP). It defines GLP as a system of management controls for non-clinical safety studies to ensure quality and reliability of test data. The document outlines the history, elements, objectives, scope and principles of GLP. It discusses key aspects like standard operating procedures, quality assurance units, the roles of management, study directors and compliance monitoring authorities. Overall, the document serves as a comprehensive overview of GLP for conducting quality non-clinical safety studies.
This document discusses personnel training and responsibilities in the pharmaceutical industry. It outlines that manufacturers must have qualified personnel to carry out tasks and ensure quality assurance. Key personnel such as production heads and quality heads must be independent and possess scientific education and experience. Their responsibilities include authorizing documents, monitoring manufacturing environment, training staff, and approving materials. The authorized person is responsible for approving finished product batches and ensuring compliance with regulations before release. Training programs should be provided for all staff.
This document discusses process validation in the pharmaceutical industry. It defines process validation and describes it as having three stages: process design, process qualification, and continued process verification. The objectives and requirements of each stage are explained. Process validation helps ensure a process consistently produces products meeting specifications and quality attributes. It involves understanding and controlling sources of variation. Validation protocols, reports, teams, and the lifecycle are also reviewed to explain how process validation is planned and documented.
Mr. Krushnakant K. Wable gave a presentation on current good manufacturing practices (cGMP) under the guidance of Dr. Sonali Mahaparale and Dr. D. Y. Patil. The presentation defined cGMP as regulations enforced by the FDA to ensure proper design, monitoring, and control of manufacturing processes and facilities. It also explained that cGMP helps assure the identity, strength, quality and purity of drug products. The presentation covered key components of cGMP like personnel, premises, equipment, standard operating procedures, raw materials, self inspections, and warehousing. It emphasized that cGMP helps prevent contamination, mix-ups, failures and errors to ensure products meet quality standards.
This document discusses vendor qualification and product returns and recalls in the pharmaceutical industry. It provides definitions and guidelines for recall classification, initiation, and responsibilities of recalling firms. It also discusses vendor qualification categories and criteria for selection. The key points are that recall means removing violating products from the market, while return means sending unused products back. Firms must qualify vendors on various criteria like quality, delivery, and facilities to ensure consistent product quality.
WHO Good Manufacturing Practice Requirements
Good Manufacturing Practice is the part of quality assurance that ensures that products are consistently manufactured and controlled to the quality standards appropriate to their intended use.
The document discusses Good Manufacturing Practices (GMP) and contamination prevention. It covers types of contamination, sources, and how to prevent them through practices like personal hygiene, sanitation, cleaning, and equipment maintenance. GMP regulations require facilities, equipment, personnel training, and documentation to help assure product quality and safety.
Hazard analysuis food packaging manufacturing(2)Tom Dunn
This document discusses good manufacturing practices for flexible packaging converting. It begins by introducing food safety management systems and how they relate to manufacturing food packaging. It then covers topics like hazard analysis, common language in food safety, and rules for management systems. The document stresses that while GMP structures are similar, the details depend on the product being manufactured. It also discusses enforcing management systems through accountants and regulatory agencies. Overall, the document promotes using good manufacturing practices and food safety management systems to ensure supply chain integrity and public health.
Quality assurance and good manufacturing practices are important to ensure drug quality and safety. Quality assurance covers all factors that influence a product's quality and requires adequate resources. Good manufacturing practices provide quality standards for production and controls to ensure products meet their intended use as required by regulations. Key elements of good manufacturing practices include facilities, equipment, documentation, materials management, production controls, packaging and labeling, storage, and validation. While GMPs vary between countries, the overall goals are similar in requiring design and maintenance standards, standard operating procedures, quality control, trained personnel, and management oversight.
This document discusses Good Manufacturing Practices (GMP) and current Good Manufacturing Practices (cGMP). It provides definitions of GMP and cGMP, explaining that GMP ensures quality and safety in manufacturing while cGMP refers specifically to FDA regulations. The principles and regulations of GMP, cGMP, and their comparison are outlined. Key aspects like facilities, equipment, documentation, packaging and labeling, quality control, and standard operating procedures are summarized.
In this slide contains introduction, qualification, preventive maintenance, requalification method.
Presented by: Malarvannan M (Department of pharmaceutical analysis).RIPER, anantapur
Cleaning validation is important to ensure safety and prevent contamination during pharmaceutical production. It involves collecting data to prove cleaning procedures consistently remove residues to acceptable limits. Key aspects of validation include defining cleaning procedures, acceptance criteria, sampling methods, and analytical techniques. Validation should continue if procedures or products change. Overall, cleaning validation demonstrates equipment is suitably cleaned between batches to maintain quality as required by cGMP regulations.
The document outlines good manufacturing practices (GMP) that must be followed to produce safe products. It discusses personnel hygiene practices, facility requirements, storage practices, process equipment guidelines, cleaning and sanitation procedures, pest control measures, and documentation standards that are necessary to ensure product quality and safety.
This document outlines Good Manufacturing Practices (GMP) for producing sterile pharmaceutical products. It discusses that GMP ensures products are consistently manufactured and controlled to quality standards for their intended use. Specific requirements are provided for facilities, equipment, environmental controls, personnel hygiene and sanitation practices when manufacturing sterile injectables, ophthalmic preparations and other sterile products to minimize risks of contamination. Production must follow documented procedures and strict aseptic techniques to ensure the sterility and quality of manufactured medicines.
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.
This document provides an overview of good manufacturing practices (GMP) in the pharmaceutical industry. It begins with definitions of GMP and discusses its early history starting in the 1900s with no regulations. Key events that led to increased regulation include Upton Sinclair's 1905 book The Jungle exposing unsanitary meat plants and the 1906 Pure Food and Drug Act. The document then outlines the timeline of major GMP regulations from 1902 to the present. It provides details on key areas covered by GMP including personnel, premises, equipment, process validation, and quality assurance.
Good Warehousing Practices (GWH) in Pharmaceutical IndustrySwapnil Karale
Mr. Swapnil Karale has over 10 years of experience in the pharmaceutical industry and is qualified as a cGMP auditor. He has expertise in quality assurance, auditing, validation, calibration and training. The presentation covers good warehousing practices, including premises, security, temperature and humidity control, equipment, personnel, sanitation, receipt and storage of goods, packing for transportation, and transportation. Maintaining proper documentation of all warehousing activities is emphasized.
This document discusses cross-contamination, mix-ups, and clean room practices. It defines key terms like contamination, cross-contamination, and mix-ups. It identifies sources of contamination like personnel, equipment, airflow, and discusses prevention methods like facility design, cleaning validation, and cleanroom classification systems. Personnel clothing, hygiene, and cleaning practices are important to prevent contamination from people. Proper airflow and HVAC systems also help control contamination. Regular monitoring and maintenance of cleanrooms is necessary to ensure quality manufacturing of pharmaceutical products.
The document discusses the selection criteria for container closure systems for pharmaceutical products. There are four main criteria: 1) Protection - the container closure must protect the drug from factors like light, oxygen, and moisture that could degrade it. 2) Compatibility - the container and drug must not interact in ways that could affect drug stability or safety. 3) Safety - the materials used cannot leach harmful substances that the patient could be exposed to. 4) Performance - the container closure must function properly to deliver the drug as intended and support compliance. Compatibility testing, extraction studies, and functionality tests help evaluate different container closure systems.
10 Principles of Good Manufacturing Practice (GMP)Arrelic
The document discusses the 10 principles of Good Manufacturing Practice (GMP). It explains that GMP establishes minimum standards for manufacturing products to prevent issues like contamination. Following the 10 principles can help make GMP a lifestyle at companies. The principles include having written procedures, carefully following procedures, documenting work, validating systems, facility and equipment design, maintaining facilities/equipment, job competence, cleanliness, controlling processes, and conducting audits. The document provides details on each principle and how following them helps ensure quality, compliance and safety.
This document provides an introduction to Good Laboratory Practices (GLP). It defines GLP as a system of management controls for non-clinical safety studies to ensure quality and reliability of test data. The document outlines the history, elements, objectives, scope and principles of GLP. It discusses key aspects like standard operating procedures, quality assurance units, the roles of management, study directors and compliance monitoring authorities. Overall, the document serves as a comprehensive overview of GLP for conducting quality non-clinical safety studies.
This document discusses personnel training and responsibilities in the pharmaceutical industry. It outlines that manufacturers must have qualified personnel to carry out tasks and ensure quality assurance. Key personnel such as production heads and quality heads must be independent and possess scientific education and experience. Their responsibilities include authorizing documents, monitoring manufacturing environment, training staff, and approving materials. The authorized person is responsible for approving finished product batches and ensuring compliance with regulations before release. Training programs should be provided for all staff.
This document discusses process validation in the pharmaceutical industry. It defines process validation and describes it as having three stages: process design, process qualification, and continued process verification. The objectives and requirements of each stage are explained. Process validation helps ensure a process consistently produces products meeting specifications and quality attributes. It involves understanding and controlling sources of variation. Validation protocols, reports, teams, and the lifecycle are also reviewed to explain how process validation is planned and documented.
Mr. Krushnakant K. Wable gave a presentation on current good manufacturing practices (cGMP) under the guidance of Dr. Sonali Mahaparale and Dr. D. Y. Patil. The presentation defined cGMP as regulations enforced by the FDA to ensure proper design, monitoring, and control of manufacturing processes and facilities. It also explained that cGMP helps assure the identity, strength, quality and purity of drug products. The presentation covered key components of cGMP like personnel, premises, equipment, standard operating procedures, raw materials, self inspections, and warehousing. It emphasized that cGMP helps prevent contamination, mix-ups, failures and errors to ensure products meet quality standards.
This document discusses vendor qualification and product returns and recalls in the pharmaceutical industry. It provides definitions and guidelines for recall classification, initiation, and responsibilities of recalling firms. It also discusses vendor qualification categories and criteria for selection. The key points are that recall means removing violating products from the market, while return means sending unused products back. Firms must qualify vendors on various criteria like quality, delivery, and facilities to ensure consistent product quality.
WHO Good Manufacturing Practice Requirements
Good Manufacturing Practice is the part of quality assurance that ensures that products are consistently manufactured and controlled to the quality standards appropriate to their intended use.
The document discusses Good Manufacturing Practices (GMP) and contamination prevention. It covers types of contamination, sources, and how to prevent them through practices like personal hygiene, sanitation, cleaning, and equipment maintenance. GMP regulations require facilities, equipment, personnel training, and documentation to help assure product quality and safety.
Hazard analysuis food packaging manufacturing(2)Tom Dunn
This document discusses good manufacturing practices for flexible packaging converting. It begins by introducing food safety management systems and how they relate to manufacturing food packaging. It then covers topics like hazard analysis, common language in food safety, and rules for management systems. The document stresses that while GMP structures are similar, the details depend on the product being manufactured. It also discusses enforcing management systems through accountants and regulatory agencies. Overall, the document promotes using good manufacturing practices and food safety management systems to ensure supply chain integrity and public health.
This document outlines Good Manufacturing Practices (GMP) for food production. It discusses key principles of GMP including documentation, validation, sanitation, personnel training, auditing, and process and quality control. The goal of GMP is to consistently produce safe, pure, and effective products by establishing controls and standards at all stages of manufacturing.
Good manufacturing practices for complementary medicinesTGA Australia
This presentation provides an overview of GMP clearance application process, the TGA compliance risk framework, major deficiencies and manufacturing quality challenges.
Records created by healthcare workers are considered health records under UK law. Health records must be factual, consistent, accurate, dated, timed, signed, and avoid jargon. Poor record keeping can lead to issues like mistakes in care, complaints, disciplinary action, and even criminal proceedings. The main barrier to good record keeping is a lack of time. Records made by non-registered staff must be regularly countersigned by their supervisor.
Production Planning and Control (Operations Management)Manu Alias
Production planning and control aims to efficiently utilize resources like materials, people, and facilities to transform raw materials into finished products in an optimal manner. It involves planning, coordinating, and controlling all production activities from procurement to shipping. The key objectives are proper coordination of activities, better control, ensuring uninterrupted production, capacity utilization, and timely delivery. The main stages are planning, action, and control. Important functions include production planning like estimating, routing, and scheduling, as well as production control functions like dispatching, follow up, and inspection. A master production schedule is a production plan that states what will be made, how many units, and when, to coordinate activities and resources.
The document outlines the production planning and control hierarchy which includes strategic and business planning, demand management, sales and operations planning, master production scheduling, material requirements planning, capacity requirements planning, and shop floor control. It then defines production/manufacturing as the process of converting raw materials into finished products. Planning involves looking ahead and setting actions to achieve objectives, while control compares actual performance to plans. Production planning and control aims to effectively utilize resources to satisfy customer demand and create profits.
Manufacturing planning and control systems
Chapter 4
1.Capacity Planning
2.CAPACITY PLANNING'S ROLE IN MPC SYSTEMS.
3.CAPACITY PLANNING AND CONTROL TECHNIQUES.
4.MANAGEMENT AND CAPACITY PLANNING.
5.DATA BASE REQUIREMENTS.
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
FDA Data Integrity Issues - DMS hot fixesVidyasagar P
The document discusses data integrity, including popular causes of integrity issues, consequences, and fixes related to document management systems. It provides definitions of data integrity and discusses regulatory requirements around integrity from agencies like the FDA. Specifically, it summarizes the FDA's 21 CFR Part 11 regulation, which considers electronic records equivalent to paper if certain controls are in place. It also discusses application integrity policies and concludes that ensuring data integrity is important to rebuild regulatory trust if issues are found.
A review on Production Planning and Control - Definitions of production, production planning, production control, production management, steps involved in production planning, steps involved in production control
Current good manufacturing practices and current good compounding Areej Abu Hanieh
The document discusses current good manufacturing practices (cGMP) regulations established by the FDA to ensure minimum quality standards for drug products. It covers cGMP requirements for facilities, equipment, components, production processes, packaging, labeling, quality control, audits and more. The regulations aim to help manufacturers produce safe and effective pharmaceuticals for patients.
This document outlines good manufacturing practices for food production facilities. It discusses contamination prevention through proper employee hygiene like handwashing, illness policies, and restricting jewelry/nails. Food handling best practices are also covered, such as storage temperatures, cleaning equipment and work areas, and first-in-first-out ingredient rotation. The presentation emphasizes that careless employee behaviors can cause contamination and outlines policies for clothing, illness reporting, and prohibiting eating or smoking in production areas.
Manufacturing planning & control (mpc) systemYash Dave
The document discusses manufacturing planning and control systems (MPC) and master production scheduling (MPS). Some key points:
- MPC systems help formulate plans to meet business objectives and identify resource gaps. They facilitate feedback across suppliers and scheduling.
- An MPS is a time-phased statement of how resources will be used to meet production commitments over the planning horizon. It tends to have a short time horizon and show details like bills of materials.
- MRP was developed to address limitations of traditional inventory models like economic order quantities. It incorporates bill of material information and dependent demand to improve inventory accuracy and reduce stockouts.
On May 15, 2015, the USDA Food Safety Inspection Service (FSIS) released the final requirements for Hazard Analysis & Critical Control Points (HACCP) Systems Validations. Learn how to be ready, and avoid non-compliance and enforcement actions?
The document provides an overview of current good manufacturing practices (cGMP) as defined by the World Health Organization (WHO). It discusses key aspects of cGMP including personnel, facilities, equipment, material management, quality management, manufacturing operations, validation, sterile products, security, documentation, and records. The goal of cGMP is to consistently produce pharmaceutical products that meet quality standards for their intended use and legal requirements.
Data integrity is assuming greater importance in current Good Manufacturing Practices in FDA regulated industry with increased emphasis by other regulatory agencies like the EMA. Data integrity and security infractions are not only 21 Code of Federal Regulations (CFR) Part 11 issues but also severe CGMP violations. As FDA increases its focus on data integrity and reliability, inspectors are examining data based on multiple regulations and standards including CGMP, Good Laboratory Practices (GLP), Good Clinical Practices (GCP) and the Application Integrity Policy (AIP) in addition to FDA-recognized consensus standards.
This presentation discusses data integrity regulations and enforcement trends that have led to increased scrutiny of pharmaceutical laboratories by inspectors.
Production Planning and Control
Objective of PPC
Classification/Functions of PPC
Levels of PPC
Factors determining Production Planning Procedures
Production Planning System
Factors Determining PC procedures
The document discusses Good Manufacturing Practices (GMP) for pharmaceutical manufacturing. It outlines requirements for facilities, equipment, personnel, documentation, production processes, quality control, and other operational aspects to minimize risks and ensure consistent production of quality products. GMP covers all aspects of production and testing to maintain standards, prevent contamination and errors, and comply with regulatory guidelines.
The document discusses the history and principles of Good Manufacturing Practices (GMP). It originated after mass poisonings from contaminated drugs in the early 1900s. GMP aims to ensure consistent production of safe medicines through guidelines covering facilities, equipment, personnel, documentation, raw materials, production, and quality control. Major regulations include those from the US FDA, EU, and India. Following GMP principles during pharmaceutical manufacturing helps protect patient health.
To compare GMP requirement of India, US and Europe for tablets.Aakashdeep Raval
The document discusses Good Manufacturing Practice (GMP) requirements for tablet manufacturing in India, the US, and Europe. It provides an in-depth overview of key GMP requirements for tablet production in India, covering general facility requirements, warehousing, production areas, ancillary areas, quality control, personnel, manufacturing operations, equipment, documentation, quality assurance, and validation. The guidelines outline aspects of production and testing that impact quality, including clearly defined and controlled manufacturing processes, change control, training, facilities, equipment, and documentation.
Good manufacturing practices (gmp) Akash Saini (Dr. H. S. Gour University, Sa...Akash Saini
This document discusses Good Manufacturing Practices (GMP) which are procedures and processes used in manufacturing to ensure quality products. GMP covers all aspects of production from facilities and equipment to purchasing, personnel and documentation practices. It aims to minimize risks like contamination through validated processes, qualified personnel and compliance with standards. Key aspects of GMP include premises, equipment, personnel, documentation, quality control, self-inspection and auditing. GMP ensures that pharmaceutical products are consistently produced and controlled according to quality standards.
Schedule M is good manufacturing practices and requirements of premises, plants and equipment for pharmaceutical products.
Schedule M is a part of drugs and cosmetics act, 1940.
Schedule M- І:Requirements of factory premises for manufacture of homoeopathic preparations.
Schedule M- ІІ: :Requirements of factory premises for manufacture of cosmetics.
Schedule M- ІІІ: :Requirements of factory premises for manufacture of medical devices.
pratik ghive cGMP According to schedule Mpratikghive82
Pratik Ghive Current Good Manufacturing Practices (cGMP) Guidelines According to schedule M Cover all guidelines as per Drug and cosmetic act 1940 and ICH guidelines
This document provides an overview of requirements for Good Manufacturing Practices (GMP), Current Good Manufacturing Practices (cGMP), Good Laboratory Practices (GLP), USFDA guidelines, and ISO 9000 standards. It discusses key elements of GMP/cGMP including facilities, equipment, documentation, quality control, and compliance. It also outlines 10 key principles of GLP relating to test facility organization, quality assurance, facilities, equipment, test systems, substances, standard operating procedures, performance, reporting and record keeping. The document is intended to present information on regulatory standards for pharmaceutical manufacturing and laboratory testing.
This document provides an overview of Good Manufacturing Practices (GMP) in the pharmaceutical industry. It defines GMP and discusses why GMP is important to ensure consistent quality products and protect consumer safety. The document outlines the key principles of GMP, including facilities and equipment design, validation, documentation, quality control systems, and self-inspection. It also reviews specific GMP requirements for premises, equipment, raw materials, production, sanitation, quality audits, and more. Adhering to GMP regulations helps pharmaceutical manufacturers minimize risks and ensure their products are safe, pure, and effective.
This document provides an overview of the history and development of Good Manufacturing Practices (GMP) regulations. It discusses key events that led to the establishment of GMP standards, including unsafe drug production in the early 1900s and the Thalidomide tragedy in the 1960s. The document then outlines the main GMP guidelines covering areas like personnel, facilities, equipment, sanitation, documentation, raw materials, quality assurance, and more. It traces the timeline of major GMP-related acts and amendments between 1902-1980 to strengthen drug and medical device manufacturing standards.
Schedule M outlines Good Manufacturing Practices (GMP) that must be followed by pharmaceutical manufacturing units in India. It contains requirements for factory premises, plants, equipment, and quality assurance to ensure products are consistently manufactured and controlled to quality standards. Schedule M has two parts - Part 1 covers GMP for premises and materials, and Part 2 covers specific plant and material requirements. It provides detailed guidelines for facilities, equipment, sanitation, personnel, documentation, manufacturing, quality control, distribution, and more to help ensure therapeutic goods produced meet the required quality standards.
Good Manufacturing Practices (GMP) regulations were introduced in 1988 and amended in 2001 to ensure pharmaceutical products are consistently produced and controlled according to quality standards. GMP covers all aspects of production from starting materials to training and hygiene of staff. Detailed written procedures and documented proof of following correct procedures are required at each step of manufacturing. The goal is to minimize risks that cannot be detected by final testing and ensure consumers receive products of the specified quality.
The Sigma Test and Research Center provide testing and research facilities worldwide. Visit our website http://bit.ly/2HVkg21 and book your testing and research services. Our testing and research services rates are very cheap and our work is always quality work.
The document discusses objectives and policies of CGMP (current good manufacturing practices) and inventory management control. It provides 11 sections that outline CGMP policies related to personnel, premises, equipment, sanitation, storage, production, packaging, quality control, documentation, self-inspection, and product complaints. It also discusses the objectives of inventory control to minimize costs and disruption while ensuring adequate stock. Various techniques for inventory control are analyzed including ABC, VED, XYZ and SOS analyses.
Unit 9 -Good manufacturing practice.pptxmarakiwmame
This document defines key concepts related to current good manufacturing practices (cGMP), including:
- cGMP ensures products are consistently produced and controlled to quality standards for intended use. It covers facilities, equipment, personnel, and manufacturing procedures.
- The primary goal of cGMP is to prevent errors, contamination, and mix-ups during manufacturing that could lead to unsafe or ineffective products.
- cGMP provides a framework to help ensure products are safe, effective, and high quality. It addresses premises, equipment, documentation, personnel, packaging/labeling, quality control, distribution, validation, and recall procedures.
GMP Requirements & Drug & Cosmetic Act Provision.pptxEasy Concept
Good Manufacturing Practices (GMP) is that part of quality assurance, which ensures that products are regularly produced and controlled according to the quality standards suitable for their use.
(GMP) comes in Schedule M in D & C Act 1940 and Rules 1945.
GMPs are the requirements that the drug and methods/control /facilities used in their manufacturing, processing and packaging conforms to practice that will assure the safety and efficacy of the product.
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.
cGMP as per shedule M outlines the Good Manufacturing Practices that must be followed for pharmaceutical manufacturing according to the Drugs and Cosmetics Act of India. It covers requirements for facilities, equipment, personnel, sanitation, documentation, quality control, packaging and labeling. All aspects of production from raw materials to finished products must meet GMP standards to ensure consistency and quality of manufactured drugs. Detailed written procedures and records are required for all manufacturing processes.
This document defines key terms related to Good Manufacturing Practice (GMP) for pharmaceuticals. It discusses GMP requirements for facilities, equipment, documentation, materials, processes, quality control, quality assurance, personnel, sanitation, complaints, and recalls. Key points include that GMP aims to consistently produce quality medicines through validated processes and facilities, qualified staff, appropriate materials and equipment, and defined procedures. Quality assurance covers all activities influencing quality, while quality control tests and releases products. Personnel must be properly trained and hygienic practices followed.
This document outlines good manufacturing practices (GMPs) for cosmetics manufacturing. It discusses establishing a quality management system and quality assurance programs. Personnel should be adequately trained. Premises, equipment, and production processes should be designed and maintained to minimize risks of contamination. Thorough documentation, quality control testing, and complaint handling are required. The GMPs are intended to assure consistent high quality products that are safe for consumers.
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- Video recording of this lecture in English language: https://youtu.be/kqbnxVAZs-0
- Video recording of this lecture in Arabic language: https://youtu.be/SINlygW1Mpc
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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
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2. GMP regulations were introduced in the form of
amended Schedule M in 1988 has again been amended
in a major way by the Drug and Cosmetic Rules,2001.
That embraces Rules71,74,76 and 78 under the Drug
and Cosmetic Rules,1945.
This rules were not to apply to the manufacturers who
are licensed to manufacture drugs for period up to 31st
December,2004.
3. The GMP guidelines are a means to assure the
QUALITY of the drug.
Provides a high level assurance that medicines are
manufactured in a way that ensures their SAFETY,
EFFICACY and QUALITY.
Medicines are manufactured such that they comply
with their marketing authorization.
QUALITY is built in..
4.
5. Design and construct the facilities and equipments
properly.
Follow written procedures instructions.
Document work involves SOP,BMR,MFRetc.
Validate work
Monitor facilities and equipment
Write step by step operating procedures and work on
instructions
Design, an demonstrate job competence
Protect against contamination.
Control components and product related process
Conduct planned and periodic audits
8. General Requirements
-Location and Surroundings
-Buildings and Premises
-Water System
-Disposal of Waste
Ware Housing Area
Production Area
Ancillary Area
Quality Control Area
Personnel
Health, Clothing and Sanitation of Workers
9. Manufacturing Operations and Controls
Sanitation in the Manufacturing Premises
Raw Materials
Equipments
Documentation and Records
Labels and other Printed Materials
Quality Assurance
Self Inspection and Quality Audit
Quality Control System
10. Master Formula Record
Packaging Record
Batch Packing Record
Batch Processing Record
Standard Operating Procedure
11. Location and surroundings: Avoid risk of contamination from
external environment including open sewage, drain or another
factory producing fumes, smoke etc.
Building and premises: production of drugs under hygienic
conditions, conforming to the conditions laid down in the
Factories Act, 1948
Water System: Purified Water conforming to Pharmacopoeia
specification
Disposal of waste: The disposal of sewage and effluents shall
conform with the requirements of Environment Pollution Control
Board / Bio-medical waste shall be destroyed as per the provisions
of the Bio-Medical Waste (Management and Handling) Rules, 1996
12. Adequate area
Good storage conditions
Ensure quarantine status area
Separate area for sampling of active/excipients
Safe/secure area for poisonous/hazardous
substances.
Separate area for printing/packaging
Separate area for dispensing
hormones/cytotoxic.
Separate aseptic area for sterile materials
Pest control at least once in 1 year
13.
14. Logical sequence of operations
Logical positioning of equipments
Adequate space in-working area
Construction and proper fixation of facilities in
order to avoid creation of recesses
Marked direction of flow
15. Separate rest/refreshment rooms from
manufacturing area.
Written instruction for cleaning of washrooms
which should be easily assecible.
Separate maintenance workshops
Separate animal house: Rule 150-C(3) of the
Drugs and Cosmetics Rules, 1945
16.
17. Independent of production area
Design approximately with adequate space
Separate area for biological, microbiological and
radioisotopes
Separate chemical, microbiological and
wherever required, biological testing is carried
out.
18. Competent technical staff with prescribed
qualifications and practical experience
Separate Head for QC lab not from
manufacturing unit.
Suitably qualified person for QA and QC.
Written duties of Technical & QC personnel
Sufficient number of persons employed as per
work load.
Regular in-service training
19. High level of personal hygiene.
Drug sensitivity tests e.g. penicillin
Medical examination before employment
Personnel hygiene training to all
Sick persons not allowed in working area
Clean body covering as per the duties
Tobacco / Drinks not allowed
20. Operations carried out under Supervision of
technical staff approved by Licensing authority.
Proper labelling with the name of the product, batch
number, batch size and stage of manufacture.
Products not prepared under aseptic conditions are
required to be free from pathogens like Salmonella,
Escherichia coli, Pyocyanea etc.
21. A validated cleaning procedure
Maintenance to avoid accumulation of waste.
A routine written down sanitation program
Adequate storage space for logical positioning
of equipments / materials
Well lit, particularly where visual on-line controls
22. Inventory of all raw materials
Quarantined immediately after receipt
Purchased from approved sources under valid
purchase vouchers
Authorized staff to examine each consignment
Each batch shall be considered as a separate
batch for sampling, testing.
Appropriately labeled.
Separate areas for materials under test,
approved and rejected.
Shelf life certification by QC.
Containers of raw materials should not be kept
directly on floors.
23. Adequate location, layout and design of
equipment
Accuracy / percision/ caliberation of measuring
equipments as per SOPs
Wherever possible, non-toxic/edible grade
lubricants should be used.
24. Documents essential part of QA system as well as to all
aspects of GMP.
Documents shall be approved, signed and dated by
authorized persons.
Records retained for at least one year after the expiry
date of the finished product
Data may be recorded by electronic data processing
systems or other reliable means, but Master Formulae
and detailed operating procedures relating to the
system in use shall also be available in a hard copy to
facilitate checking of the accuracy of the records
25. Appropriate labels
Separate storage
Labels to be checked by QC
Record keeping of all the receipts
Labels shall also shall indicate name of the
formulation,concentration, manufacturing date,
expiry date etc.
26. GMP/GLP/GCP Compliant
Arrangements for correct starting and packaging
materials.
Adequate controls on starting materials,
intermediate products, and bulk products
In-process controls, calibrations, and
validations
Finished product released only after QC
assurance.
27. Master Formula Record should be their relating to all
manufacturing procedures for each product and batch size to be
manufactured.
It should contain:-
Name of the product with reference code.
The patent along with generic name.
Description of dosage form, strength, composition of product and
batch size.
Detail regarding starting materials.
Statement of expected final yield with acceptable limit
Methods for cleaning, assembling, caliberating of equipments.
Packing details and specimen labels.