This presentation provides an overview of the role that a computerized quality management system plays in a manufacturer practising Good Manufacturing Practices and compares it's complimentary functions against an Enterprise Resource Planning System
A Practical Approach to Implementing ICH Q10 Pharmaceutical Quality Systemswtgevents
The document provides an overview of implementing a pharmaceutical quality system according to ICH Q10 guidelines. It discusses establishing the foundation through following procedures and defining a quality policy. It then outlines a "simple process" to implement key elements like quality objectives, continual improvement plans, and management reviews. The goal is to enhance quality and facilitate innovation using a risk-based approach throughout the product lifecycle.
This is a presentation based on ICH Q10, Pharmaceutical Quality System, It was shared recently with participants of a training session arranged by Ingrope Information Services karachi at marriot Hotel. I am uploading for the benefits of all pharma colleagues, specially the junior ones.
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.
This document outlines the Six System Inspection Model used by the US FDA to inspect pharmaceutical manufacturing establishments. The six systems are: Quality System, Facilities and Equipment System, Materials System, Production System, Packaging and Labeling System, and Laboratory Control System. The model provides a comprehensive and organized framework to evaluate if establishments are complying with cGMP requirements across all key aspects of pharmaceutical production.
The document discusses quality management systems (QMS) and good manufacturing practices (GMP) and their benefits for businesses. It provides an overview of the key elements of a QMS and explains that a QMS establishes procedures and processes to ensure quality control across all aspects of a business. It then describes GMP guidelines which outline manufacturing and testing standards for pharmaceuticals and medical devices to ensure product quality and compliance. The document notes that many countries have legislation requiring companies to follow GMP procedures.
The document discusses calculation of yields, production record review, and change control in the pharmaceutical industry. It provides definitions and requirements for theoretical yield, actual yield, and practical yield calculation. It states that all production records must be reviewed and approved before batch release. Any unexplained discrepancies or failed batches must be investigated. The document also defines minor, major, and critical changes and the proper change control process, including documenting the request, assessing the change, planning implementation, verifying the impact, implementing, and closing out the change.
The document discusses quality management systems and the six system inspection model used by the FDA to ensure compliance with cGMP regulations. 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 provides an overview and lists the relevant cGMP subparts that govern inspections of that system. The goal is to help pharmaceutical manufacturers implement quality systems to meet FDA requirements.
Quality Systems Approach to Pharmaceutical cGMPReddy N
This guidance provides a quality systems model that aligns with CGMP regulations to help manufacturers implement modern quality systems approaches. It describes key quality systems concepts such as quality by design, quality risk management, corrective and preventive action, and change control. The guidance explains how the quality unit's responsibilities correlate with quality assurance and quality control functions. It presents a quality systems model organized into sections for management responsibilities, resources, manufacturing operations, and evaluation activities. The model identifies how each quality systems element aligns with specific CGMP regulations.
A Practical Approach to Implementing ICH Q10 Pharmaceutical Quality Systemswtgevents
The document provides an overview of implementing a pharmaceutical quality system according to ICH Q10 guidelines. It discusses establishing the foundation through following procedures and defining a quality policy. It then outlines a "simple process" to implement key elements like quality objectives, continual improvement plans, and management reviews. The goal is to enhance quality and facilitate innovation using a risk-based approach throughout the product lifecycle.
This is a presentation based on ICH Q10, Pharmaceutical Quality System, It was shared recently with participants of a training session arranged by Ingrope Information Services karachi at marriot Hotel. I am uploading for the benefits of all pharma colleagues, specially the junior ones.
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.
This document outlines the Six System Inspection Model used by the US FDA to inspect pharmaceutical manufacturing establishments. The six systems are: Quality System, Facilities and Equipment System, Materials System, Production System, Packaging and Labeling System, and Laboratory Control System. The model provides a comprehensive and organized framework to evaluate if establishments are complying with cGMP requirements across all key aspects of pharmaceutical production.
The document discusses quality management systems (QMS) and good manufacturing practices (GMP) and their benefits for businesses. It provides an overview of the key elements of a QMS and explains that a QMS establishes procedures and processes to ensure quality control across all aspects of a business. It then describes GMP guidelines which outline manufacturing and testing standards for pharmaceuticals and medical devices to ensure product quality and compliance. The document notes that many countries have legislation requiring companies to follow GMP procedures.
The document discusses calculation of yields, production record review, and change control in the pharmaceutical industry. It provides definitions and requirements for theoretical yield, actual yield, and practical yield calculation. It states that all production records must be reviewed and approved before batch release. Any unexplained discrepancies or failed batches must be investigated. The document also defines minor, major, and critical changes and the proper change control process, including documenting the request, assessing the change, planning implementation, verifying the impact, implementing, and closing out the change.
The document discusses quality management systems and the six system inspection model used by the FDA to ensure compliance with cGMP regulations. 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 provides an overview and lists the relevant cGMP subparts that govern inspections of that system. The goal is to help pharmaceutical manufacturers implement quality systems to meet FDA requirements.
Quality Systems Approach to Pharmaceutical cGMPReddy N
This guidance provides a quality systems model that aligns with CGMP regulations to help manufacturers implement modern quality systems approaches. It describes key quality systems concepts such as quality by design, quality risk management, corrective and preventive action, and change control. The guidance explains how the quality unit's responsibilities correlate with quality assurance and quality control functions. It presents a quality systems model organized into sections for management responsibilities, resources, manufacturing operations, and evaluation activities. The model identifies how each quality systems element aligns with specific CGMP regulations.
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.
This document discusses change control in the pharmaceutical industry. It begins by defining change control as a formal system to review proposed or actual changes that could affect facilities, systems, equipment, or processes. The functions of change control are then outlined as identifying, reviewing, approving, validating, analyzing, and monitoring changes. The areas of change that would require control are described, including manufacturing, quality control, research and development, engineering, and marketing. Finally, the document states that written procedures and documentation like standard operating procedures and change control forms are necessary parts of the change control system.
1) A systematic change control process is important in the pharmaceutical industry to ensure that any changes made to products or systems are properly documented, reviewed, and approved. Major changes may require regulatory approval while minor changes do not.
2) The procedure involves an initiating department submitting a change request form detailing the proposed change and its justification. Changes are classified as major or minor. Major changes such as formulation or manufacturing process changes require approval from quality assurance.
3) A structured change control system provides benefits like consistent management of changes, maintaining documentation and history of changes, and demonstrating regulatory compliance.
The document discusses key aspects of change control processes. It describes calculating theoretical, actual, and practical yields. It also covers reviewing production records before batch release and investigating discrepancies. Finally, it outlines the types, levels of approval, and steps of the change control process, including documenting requests, assessing impacts, planning implementation, and verifying changes.
According to new syllabus of PCI M.Pharm 1st sem. students can directly utilize this ppt for their study. As per PCI new syllabus QA STUDENTS find this ppt very use full.
This document discusses quality control and good manufacturing practices. It defines quality control and quality assurance, explaining that quality control focuses on detecting errors while quality assurance aims to prevent failures. The document then covers key aspects of good manufacturing practices, including requirements for facilities, equipment, materials, processes, packaging, labeling, documentation, and personnel. It describes the duties of various quality control roles to ensure products meet defined standards and comply with regulations. The objectives are full compliance with drug rules and GMP standards while introducing new products annually, to be measured by key performance indicators.
1) The TGA inspection process for manufacturers faces challenges from high workloads, incomplete sponsor applications, and an increase in identified manufacturing deficiencies requiring follow-up.
2) The TGA and sponsors can both take actions to address these challenges, such as sponsors notifying the TGA early of changes to minimize wasted inspection planning. The TGA is exploring process improvements and incentives to reduce workloads.
3) Common manufacturing deficiencies identified by TGA inspectors include inadequate quality management systems, personnel training, equipment and facility qualification, process validation, and quality control testing. Addressing these deficiencies requires effective manufacturer corrective actions.
Quality management system in pharmaceutical industryselinasimpson2401
The document discusses quality management systems in the pharmaceutical industry. It provides an overview of the key components of an effective quality management system, including quality management, quality assurance, evaluation analysis, quality risk management tools, preventive action, and risk management. It describes how a quality management system should function as the central hub connecting six subsystems: quality system, production system, facilities and equipment system, laboratory controls system, materials system, and packaging and labeling system. The document also lists and provides brief descriptions of several common quality management tools used in pharmaceutical quality systems, such as check sheets, control charts, Pareto charts, scatter plots, Ishikawa diagrams, and histograms.
ICH Q10 provides a harmonized model for a pharmaceutical quality system throughout the lifecycle of a product. It describes a quality management system for the pharmaceutical industry. The objectives of the Q10 model are to achieve product realization, establish and maintain a state of control, and facilitate continual improvement. ICH Q10 covers pharmaceutical development, technology transfer, commercial manufacturing, and product discontinuation. It is intended to enhance existing good manufacturing practice requirements and be used together with them.
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.
Quality Management system in accordance to Vol. 4 EU Guidelines for GMP for Medicinal Products for Human and Veterinary Use Chapter 1 Pharmaceutical QS
ICH Q10/ Q7.
ISO 9001/2015
Master batch record,batch production record ,Quality Audit Type and plan &Rec...KarishmaFuse
Standard Operating procedure(SOP), Preparation review ,Approval Issuance of master batch Record MBR and Batch Production Record (BPR) and Quality Audit Type, plan and Objectives.
The document discusses various documentation practices that are important in the pharmaceutical industry. It covers documentation requirements for raw materials, packaging materials, production records, quality control records, and other key areas. Maintaining proper documentation is essential for regulatory compliance, process validation, batch traceability, and ensuring product quality.
The document discusses quality audits in the pharmaceutical industry. It defines quality audits as evaluations of a manufacturer's compliance with Good Manufacturing Practices (GMP) in production and quality control. The goals are to detect any issues in GMP implementation and recommend corrective actions. The document outlines various types of quality audits, including self-inspections and elements of a systemic audit program like audit formats, checklists, trained personnel, and reporting. It emphasizes that quality audits help ensure GMP compliance, detect potential problems, improve quality programs, and increase management awareness of issues.
Quality & compliance excellence in pharmaceuticalsAnvita Bharati
Quality can be defined in several ways including conformance to specifications, fitness for use, and value for price paid. It is judged based on factors like performance, reliability, and support services provided. Pharmaceutical products have higher quality standards and more regulations compared to consumer goods due to their intended use and potential risks. Ensuring compliance with various quality guidelines is important for patient safety and involves establishing quality systems, policies, procedures, documentation, and ongoing assessments like audits and corrective actions. Non-compliance can result in issues like complaints, recalls, and regulatory actions.
Self-inspection and quality audits are important parts of a quality management system to ensure ongoing compliance with good manufacturing practices (GMP). Self-inspections evaluate all aspects of production and quality control to detect any noncompliance and recommend corrective actions. The self-inspection team should consist of objective personnel not from the departments being inspected. The inspection covers facilities, equipment, documentation, hygiene, and other GMP requirements. Quality audits supplement self-inspections by examining the entire quality system. Supplier audits also help ensure materials meet specifications. GMP inspectors evaluate a company's self-inspection program through reviewing records and policies to check that inspections are properly conducted and documented.
Objectives and policies of cGMP & Inventory management and controlArul Packiadhas
This document discusses objectives and policies of CGMP (current good manufacturing practices) and inventory management and control. It outlines the importance of CGMP in assuring quality standards and preventing issues. CGMP regulations provide systems to properly design, monitor, and control manufacturing processes. The document also describes objectives of inventory control such as minimizing costs and ensuring adequate stock levels. It provides details on inventory management policies, documentation requirements, and quality control standards under CGMP.
This document discusses quality auditing in the pharmaceutical industry. It defines quality auditing and explains that it involves systematically examining quality systems to determine compliance. The document outlines different types of audits including internal, external, regulatory, product, process, and system audits. It discusses planning, conducting, and reporting on audits. The key objectives of audits are to ensure quality, assess effectiveness of quality assurance systems, and permit timely correction of any issues. Audits help build confidence in quality management practices and identify areas for improvement.
The document discusses packaging and labelling of food products. It covers several key points:
1) Packaging serves to contain, protect, and preserve food products. It allows for storage, transportation, and communication of important information to consumers.
2) Labelling of food products is important to inform consumers and ensure safe handling and use of products. It aims to provide details on ingredients, nutrition information, and instructions.
3) Regulations in the Philippines require certain mandatory information on labels including the product name, net contents, list of ingredients, and manufacturer details. Compliance with labelling rules helps prevent issues and protects consumer health.
The document provides guidance for students taking an exam on designing packed lunch containers. It outlines the key functions of packaging as transport, contain, preserve, display, protect, and inform. It emphasizes that paper and card will be the compulsory material. It suggests considering who the user may be and what foods need to be contained. Finally, it gives examples of existing packed lunch containers and packaging that fulfill the different functions through materials used and design features.
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.
This document discusses change control in the pharmaceutical industry. It begins by defining change control as a formal system to review proposed or actual changes that could affect facilities, systems, equipment, or processes. The functions of change control are then outlined as identifying, reviewing, approving, validating, analyzing, and monitoring changes. The areas of change that would require control are described, including manufacturing, quality control, research and development, engineering, and marketing. Finally, the document states that written procedures and documentation like standard operating procedures and change control forms are necessary parts of the change control system.
1) A systematic change control process is important in the pharmaceutical industry to ensure that any changes made to products or systems are properly documented, reviewed, and approved. Major changes may require regulatory approval while minor changes do not.
2) The procedure involves an initiating department submitting a change request form detailing the proposed change and its justification. Changes are classified as major or minor. Major changes such as formulation or manufacturing process changes require approval from quality assurance.
3) A structured change control system provides benefits like consistent management of changes, maintaining documentation and history of changes, and demonstrating regulatory compliance.
The document discusses key aspects of change control processes. It describes calculating theoretical, actual, and practical yields. It also covers reviewing production records before batch release and investigating discrepancies. Finally, it outlines the types, levels of approval, and steps of the change control process, including documenting requests, assessing impacts, planning implementation, and verifying changes.
According to new syllabus of PCI M.Pharm 1st sem. students can directly utilize this ppt for their study. As per PCI new syllabus QA STUDENTS find this ppt very use full.
This document discusses quality control and good manufacturing practices. It defines quality control and quality assurance, explaining that quality control focuses on detecting errors while quality assurance aims to prevent failures. The document then covers key aspects of good manufacturing practices, including requirements for facilities, equipment, materials, processes, packaging, labeling, documentation, and personnel. It describes the duties of various quality control roles to ensure products meet defined standards and comply with regulations. The objectives are full compliance with drug rules and GMP standards while introducing new products annually, to be measured by key performance indicators.
1) The TGA inspection process for manufacturers faces challenges from high workloads, incomplete sponsor applications, and an increase in identified manufacturing deficiencies requiring follow-up.
2) The TGA and sponsors can both take actions to address these challenges, such as sponsors notifying the TGA early of changes to minimize wasted inspection planning. The TGA is exploring process improvements and incentives to reduce workloads.
3) Common manufacturing deficiencies identified by TGA inspectors include inadequate quality management systems, personnel training, equipment and facility qualification, process validation, and quality control testing. Addressing these deficiencies requires effective manufacturer corrective actions.
Quality management system in pharmaceutical industryselinasimpson2401
The document discusses quality management systems in the pharmaceutical industry. It provides an overview of the key components of an effective quality management system, including quality management, quality assurance, evaluation analysis, quality risk management tools, preventive action, and risk management. It describes how a quality management system should function as the central hub connecting six subsystems: quality system, production system, facilities and equipment system, laboratory controls system, materials system, and packaging and labeling system. The document also lists and provides brief descriptions of several common quality management tools used in pharmaceutical quality systems, such as check sheets, control charts, Pareto charts, scatter plots, Ishikawa diagrams, and histograms.
ICH Q10 provides a harmonized model for a pharmaceutical quality system throughout the lifecycle of a product. It describes a quality management system for the pharmaceutical industry. The objectives of the Q10 model are to achieve product realization, establish and maintain a state of control, and facilitate continual improvement. ICH Q10 covers pharmaceutical development, technology transfer, commercial manufacturing, and product discontinuation. It is intended to enhance existing good manufacturing practice requirements and be used together with them.
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.
Quality Management system in accordance to Vol. 4 EU Guidelines for GMP for Medicinal Products for Human and Veterinary Use Chapter 1 Pharmaceutical QS
ICH Q10/ Q7.
ISO 9001/2015
Master batch record,batch production record ,Quality Audit Type and plan &Rec...KarishmaFuse
Standard Operating procedure(SOP), Preparation review ,Approval Issuance of master batch Record MBR and Batch Production Record (BPR) and Quality Audit Type, plan and Objectives.
The document discusses various documentation practices that are important in the pharmaceutical industry. It covers documentation requirements for raw materials, packaging materials, production records, quality control records, and other key areas. Maintaining proper documentation is essential for regulatory compliance, process validation, batch traceability, and ensuring product quality.
The document discusses quality audits in the pharmaceutical industry. It defines quality audits as evaluations of a manufacturer's compliance with Good Manufacturing Practices (GMP) in production and quality control. The goals are to detect any issues in GMP implementation and recommend corrective actions. The document outlines various types of quality audits, including self-inspections and elements of a systemic audit program like audit formats, checklists, trained personnel, and reporting. It emphasizes that quality audits help ensure GMP compliance, detect potential problems, improve quality programs, and increase management awareness of issues.
Quality & compliance excellence in pharmaceuticalsAnvita Bharati
Quality can be defined in several ways including conformance to specifications, fitness for use, and value for price paid. It is judged based on factors like performance, reliability, and support services provided. Pharmaceutical products have higher quality standards and more regulations compared to consumer goods due to their intended use and potential risks. Ensuring compliance with various quality guidelines is important for patient safety and involves establishing quality systems, policies, procedures, documentation, and ongoing assessments like audits and corrective actions. Non-compliance can result in issues like complaints, recalls, and regulatory actions.
Self-inspection and quality audits are important parts of a quality management system to ensure ongoing compliance with good manufacturing practices (GMP). Self-inspections evaluate all aspects of production and quality control to detect any noncompliance and recommend corrective actions. The self-inspection team should consist of objective personnel not from the departments being inspected. The inspection covers facilities, equipment, documentation, hygiene, and other GMP requirements. Quality audits supplement self-inspections by examining the entire quality system. Supplier audits also help ensure materials meet specifications. GMP inspectors evaluate a company's self-inspection program through reviewing records and policies to check that inspections are properly conducted and documented.
Objectives and policies of cGMP & Inventory management and controlArul Packiadhas
This document discusses objectives and policies of CGMP (current good manufacturing practices) and inventory management and control. It outlines the importance of CGMP in assuring quality standards and preventing issues. CGMP regulations provide systems to properly design, monitor, and control manufacturing processes. The document also describes objectives of inventory control such as minimizing costs and ensuring adequate stock levels. It provides details on inventory management policies, documentation requirements, and quality control standards under CGMP.
This document discusses quality auditing in the pharmaceutical industry. It defines quality auditing and explains that it involves systematically examining quality systems to determine compliance. The document outlines different types of audits including internal, external, regulatory, product, process, and system audits. It discusses planning, conducting, and reporting on audits. The key objectives of audits are to ensure quality, assess effectiveness of quality assurance systems, and permit timely correction of any issues. Audits help build confidence in quality management practices and identify areas for improvement.
The document discusses packaging and labelling of food products. It covers several key points:
1) Packaging serves to contain, protect, and preserve food products. It allows for storage, transportation, and communication of important information to consumers.
2) Labelling of food products is important to inform consumers and ensure safe handling and use of products. It aims to provide details on ingredients, nutrition information, and instructions.
3) Regulations in the Philippines require certain mandatory information on labels including the product name, net contents, list of ingredients, and manufacturer details. Compliance with labelling rules helps prevent issues and protects consumer health.
The document provides guidance for students taking an exam on designing packed lunch containers. It outlines the key functions of packaging as transport, contain, preserve, display, protect, and inform. It emphasizes that paper and card will be the compulsory material. It suggests considering who the user may be and what foods need to be contained. Finally, it gives examples of existing packed lunch containers and packaging that fulfill the different functions through materials used and design features.
This document provides information about product recalls in the Philippines. It defines a product recall as the removal of a product from the market due to defects or safety issues. Recalls can be initiated voluntarily by a company or ordered by the Philippine Food and Drug Administration (FDA). The FDA will classify recalls as Class I, II, or III based on the health hazard level. For ordered recalls, the FDA notifies companies and specifies actions to be taken. Companies must coordinate recall strategies and reports with the FDA, and recalls should be treated urgently to protect public health.
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.
The 2nd Speaker, Tessa Cerbolles, of the Breakout Session C Health and Food of the 1st Philippine Environment Summit discussed the regulation/government policy on maintaining the safety of food in the country
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.
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.
The document outlines the key aspects of current good manufacturing practices (cGMPs) that pharmaceutical manufacturers must follow. cGMPs come from the Food, Drug and Cosmetic Act and are enforced by the FDA. They help ensure safety and quality by requiring strict control over facilities, equipment, components, packaging, labeling, and processes. Key parts of cGMP regulations address organization, buildings, equipment, materials control, production, packaging, holding, distribution, and records. Failure to comply can result in serious legal and business consequences like product recalls or plant shutdowns.
2016-06-08 FDA Inspection Readiness - Mikael Ydemikaelyde
The document discusses preparing for FDA inspections of computer systems and IT infrastructure. It outlines developing an IT compliance plan to ensure control of data, applications, infrastructure, procedures, suppliers, documented evidence, and personnel. The plan should identify any gaps and risks. Organizations should qualify IT systems, validate computerized systems, ensure data integrity, and monitor outsourced processes. Training personnel and periodically reviewing the quality management system are also important for inspection readiness. The speaker emphasizes developing evidence of implementing regulatory requirements to demonstrate control to inspectors.
The document discusses best practices for verification and validation documentation. It covers topics like design verification and validation, design history files, process verification and validation, common issues found by regulators, and strategies for addressing issues. Key points emphasized include properly documenting design controls, validation procedures, change controls, sampling methods, and being prepared for potential FDA audits. The document provides guidance on standardizing test method documentation and understanding validation lifecycles and expectations of regulatory bodies.
Sumithra Natarajan has over 13 years of experience in procurement, quality management, and auditing. She currently works as a Senior Quality Engineer at Schneider Electric, where her responsibilities include internal audits, customer audits, quality procedures, and process improvement. Previously, she worked as a Quality Technician and completed an apprenticeship in defence manufacturing. She is a certified Six Sigma Green Belt with expertise in ISO standards, quality systems, Lean Six Sigma, and data analysis.
This document discusses Quality Management Systems (QMS) and the BM QualityMaster software. A QMS documents policies and procedures to produce high-quality products while reducing costs and increasing customer satisfaction. BM QualityMaster is a cloud-based quality management software that helps streamline quality processes, achieve compliance, and reduce risk through features such as non-conformance management, corrective action tracking, document management, and audit management. Using BM QualityMaster can benefit organizations by improving quality, optimizing processes, and meeting regulatory requirements.
Implementing Automated Qms For Business ExcellenceKhalizan Halid
The document discusses implementing an automated quality management system. It begins with background on diagnostic and analytical markets dealing with large sample volumes. Typical issues faced are resource-intensive documentation, limited auditing, and unreported issues. The need for automation is driven by increased regulations and resources. Challenges include financial resources, resistance to change, and user-friendliness. The document outlines the quality management process and developing quality management capability through generations. It emphasizes benefits like improved processes and compliance.
tQmlab is a suite for LiMS (Laboratory information Management System), QMS, ELN, Stock, Instrumen Integration and DMS etc., for multi location, 24 x 7 access as per USFDA 21 CFR Part 11 regulatory compliance.
Effectively Manage Counterfeit Parts with a Quality SolutionTIP Technologies
Mitigate risk and control counterfeit parts by managing quality within your supply chain. Discover how an effective quality management system can provide supplier approvals, certification, and performance measurements. Parts management provides the ability to track and recall any nonconforming material.
This document outlines the major responsibilities and oversight for environmental, health, and safety risk mitigation as well as GSA compliance and personnel management. Key areas of focus include compliance with various regulations through best practices, environmental incident reduction, health and safety policies and training, crisis and emergency management, insurance claims tracking, and vendor governance. Personnel management involves conducting regular meetings, performance reviews, cross-training, and team building activities.
- Over 15 years of experience in quality engineering, project management, and manufacturing engineering with a focus on electronics, electrical systems, medical devices, and telecommunications.
- Extensive experience leading quality initiatives, audits, product development, and supplier quality to improve business performance, customer satisfaction, and compliance with standards.
- Holds multiple certifications in quality engineering, Lean Six Sigma, auditing, medical devices, electronics manufacturing, and Agile project management.
- Education includes a master's degree in project management and bachelor's degrees in electrical engineering.
John F. Cuspilich has over 30 years of experience in auditing and remediation for regulated industries. He has conducted over 1000 GxP audits and remediation projects covering areas such as GMP, GLP, GCP, medical devices, and computer systems validation. He provides auditing, remediation consulting, and training services to help companies achieve and maintain regulatory compliance.
Computerized System Validation Business Intelligence SolutionsDigital-360
Executive Summary
Regulated pharmaceutical, biotech and medical device companies are challenged to develop manufacturing capabilities quickly and cost-effectively while at the same time safeguarding product quality and patient safety.
Validation has been an essential part of regulated industries for over 20 years, yet as the field has evolved, little has changed in the business, or manual, approach to validation.
The document discusses the requirements of the AS9100C quality management system standard for organizations in the aviation, space, and defense industries. It addresses key elements of the quality management system such as documentation requirements, management responsibilities, resource management, product realization processes, measurement and improvement. The standard provides a framework for customer focus, quality planning and risk management, design and development controls, purchasing, production, monitoring of processes and products, and continual improvement. Compliance with the standard helps ensure products and services meet customer and regulatory requirements.
This document describes the services of JMDV Billing and Collections, LLC. They provide billing and collections services for medical practices as well as practice management software and technology. Their key differentiators include constant awareness of industry changes, management of internal and external issues, and resolving cross-functional problems. They also have regular meetings with insurance companies. Their services include billing, collections, accounts follow up, data analysis, and specialized audits. They utilize technology for practice management, electronic medical records, billing transmission, and reporting.
Everything related to CDM. Importance of CDM, Flow Activities in Clinical Trials, Data Management Plan, Database Designing, Data Management tools, Essential Characters of the database, Standard Global Dictionaries, Data Review and Validation, Query Generation, Database Lock, Technology in CDM, and Professionals of CDM.
Risk assessment for computer system validationBangaluru
A risk assessment is a process to identify potential hazards and analyze what could happen if a hazard occurs.
Computer system validation (sometimes called computer validation or CSV) is the process of documenting that a computer system meets a set of defined system requirements.
This document discusses good documentation practices for GMP compliance. It defines what documentation is, outlines the types of documents required by GMP such as batch records and SOPs. It explains the importance of documentation for meeting legal requirements, business needs, and enabling good decision making. It provides tips for writing good documentation including structure, approvals, version control, and retention. Overall it emphasizes that documentation is critical to demonstrate regulatory compliance and quality.
This document describes a guided product selection software for gauges and instrumentation. It allows users to filter and select products and accessories based on criteria like fluid type, pressure, and temperature. It then generates a model number, prices the configuration, and produces a quotation package. The software includes features like rules engines, systems integration, business intelligence, drawings, and quality plans. It aims to simplify the selection and configuration process for complex industrial products.
Jake Essig has over 15 years of experience in quality engineering roles in the medical device industry. He has worked across the product lifecycle from new product development through post-market activities. His experience includes processes such as risk analysis, design validation, manufacturing process validation, complaint handling, and ensuring compliance with regulations. He is proficient in quality management systems and has a Six Sigma Green Belt certification.
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Getting the best out of your investments in AI in industries - a detailed guide to understanding AI development, implementation and maintenance for non-programmers
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The oldest excavated hominid bones, Lucy, was found in Africa. The second oldest was in Lenggong, Malaysia, at the site of a large meteorite impact crater. The date of the meteorite impact coincided with the rise of a paleolithic neanderthal site in Lenggong. This story explores what could have given rise to advancements of that society.
Maximizing the potential of ai in palm oil : a guide for top managementKhalizan Halid
The palm oil industry is one of the most significant contributors to the global economy. It is a huge industry that spans across multiple countries and involves various players, from smallholders to large corporations. Palm oil is used in a wide range of products, including food, cosmetics, and biofuels. However, the industry has been subjected to criticism and scrutiny over the years due to its impact on the environment. Nevertheless, palm oil is one of the most pro table land uses in the tropics and significantly contributes to economic growth and the alleviation of rural poverty. Sustainable palm oil production can also reduce poverty and provide rural infrastructure in producing countries.
The importance of maximizing AI potential in the palm oil industry cannot be overstated. By investing in the development of knowledge management systems and AI applications, palm oil companies can optimize their operations, increase their productivity, and reduce their environmental impact, leading to improved sustainability and profitability.
Dokumen ini menjelaskan konsep jaringan saraf tiruan (neural network) dengan metafora pohon pisang dan jin. Ia menggambarkan neuron sebagai pokok pisang yang berinteraksi satu sama lain, dengan jin mewakili proses pembelajaran melalui penyesuaian berat simpul dan penyebaran ralat balik. Jaringan saraf tiruan bekerja dengan mengoptimumkan fungsi biaya melalui penyesuaian berulang hingga capaian hasil yang diingink
Is writing a good way to make a steady income on the InternetKhalizan Halid
The document discusses exploring the writing market on the internet and provides answers to various questions about writing for different target audiences such as teenagers, millennials, Gen Z, and Gen X. It addresses topics around making money from writing online, building a portfolio, competing with AI writing tools, popular writing genres and subjects, leadership challenges, values of different generations, and adapting content for diverse readers. Key points covered include time required to earn $25/hour, using AI tools for ideas and research, targeting audiences based on their interests, challenges faced by different age groups, and effective channels for reaching teenage readers.
The author instructed an AI to paint a genuine fortune teller without specifying what to paint. The AI repeatedly painted the same face for a fortune teller at different ages - as a young girl, middle aged woman, and old woman. Normally the faces produced by the AI change with each iteration, so maintaining the same face across generations was unusual.
Algae are a diverse group of photosynthetic organisms that live in both marine and freshwater environments. They are one of the most common types of organisms in the world and can be found in many different forms including single-celled phytoplankton and multicellular seaweeds. Algae play an important role in the ecosystem by producing a significant portion of the oxygen and consuming carbon dioxide.
Children from all over the world are depicted in a colorful artwork created by an AI system. Various children of different races and backgrounds are shown enjoying activities like playing, learning, and being with family or friends. The artwork aims to capture the shared humanity and potential of children everywhere despite their differences.
Does an A.I. think in simple binary, black vs white terms, or does it think in 50, or 500, or 5000 or 5 million shades of thoughts? I tried experimenting this by asking an A.I to draw human faces that it thinks reflect human character traits. How subtle are A.I. thoughts? Please judge for your self.
The document is a collection of digital artworks by Rita and Khalizan Halid. It includes multiple series of abstract, figurative, and landscape paintings with titles like Unknown Warrior, Abstract Ballerina, Batik Interpretations, and Penang & Province Wellesley. Each artwork is labeled with the artist, title, and date. The document provides contact information for ordering prints or including art in the RIT.AI collection.
SoftExpert provides software solutions for advanced product quality planning (APQP) and product part approval processes (PPAP). The document discusses APQP and PPAP, including their purposes and focuses. It then describes SoftExpert's product lifecycle management software, which enables companies to manage all aspects of a product's lifecycle. The software includes features like workflows, bills of materials, documents, inspections, forms, and analytics. Finally, the document provides testimonials from customers who implemented SoftExpert's software to improve their product development and approval processes.
The document outlines the vision, mission, philosophy, values, objectives, and goals of XXX International College. The vision is to propagate awareness of Allah's unity and the teachings of Prophet Muhammad throughout mankind and promote willingness to submit to Allah's will. The mission is to educate and nurture students through various means to develop graduates who are aware of and willing to practice Islamic teachings and values. The philosophy and values that guide the college are awareness of and submission to Allah. Objectives and goals are outlined for the pillars of process, content, activities, organization, community, and environment to realize the vision and mission.
Based on a very true story -
Around the turn of the millenium, I befriended an 80-year old ex-serviceman who came from the one of the great war days and a very smart computer programmer from a national space agency. The ex-serviceman always had ideas that sounded very strange which he was not able to explain the reasons for. However, upon further detailed investigation, we always found that his ideas were based on some fundamental truths and facts. Over the years we learnt to trust his hunches.
One day, he found out that I was flying drones and he told me to fly drones all over the world to spread mushroom spores because, according to him, the world needs more rain. As usual, he was not able to explain why. I did further research and as usual found out that he good reasons.
However, flying drones all over the world was almost an impossibility for me. So instead of flying them, we came up with the idea of impressing people on the need to plant more mushroom and hope that in each region, someone will undertake the endeavour.
This movie was the result of his idea. We wanted people to step into movie theatres thinking that mushroom is food. And for them to think that the Earth is a living, “thinking” being having her own “consciousness” with mushrooms being a vital mechanism in that planetary brain. The movie was supposed to be developed with CGI into a 3D 360-degree VR view to immerse the audience into the experiencing a planet-sized brain inside the Earth.
The movie idea was aborted when my good friend suddenly passed on.
Cybersecurity environment in malaysia and the function of internal auditorKhalizan Halid
The document discusses cybersecurity in Malaysia and the role of internal auditors. It begins with definitions of cybersecurity and examples of vulnerabilities and exploits. It then discusses the importance of cybersecurity, impacts of threats, and challenges around legal and regulatory issues. The role of governments in establishing laws and initiatives is covered. Examples of national cybersecurity initiatives in countries like Canada, Germany, China, and the US are provided. The document concludes with an overview of the state of cybersecurity in Malaysia, including the vision and activities of CyberSecurity Malaysia and programs like MyCERT and Cyber999.
I believe that the most important thing an organization should do (in fact, that's why they are called organizations) is to align and galvanize each and every individual's goals, each team, each workgroup, each staff, each contractor with the goals of the organization.
This document discusses component-based development, including using components through external and internal invocation, development processes, project organization, and benefits such as consistency through standards application, predictability based on best practices, and manageability through production and delivery by components.
Goal congruence is important for organizational excellence. It means aligning individual executive's goals with organizational goals by cascading goals down from the organization to divisions, departments, and individuals. Performance management is used to ensure employee activities and outputs support organizational strategy and goals. Strategy maps and performance scorecards are tools used to align goals and monitor strategy execution.
The document discusses business intelligence and data warehousing. It describes the evolution of business intelligence from manual data retrieval and report preparation to modern integrated systems that provide analytics, dashboards, reporting, and key performance indicators. The Performa BI Suite is presented as a user-friendly business intelligence software that offers advanced visualization tools, multidimensional analysis, and integrated analytics, dashboards, and reporting in a single platform. Testimonials from users praise Performa for its ease of use, stability, and ability to meet reporting and analysis needs.
The document introduces DreamApps, a suite of browser-accessed business applications covering ERP, CRM, supply chain management, and portals. DreamApps is built on an Enterprise Operating System platform for assembling, maintaining, and running enterprise applications. It then describes DreamApps solutions for small/medium businesses, workplaces, mobile access, and point-of-sale. Key advantages include unlimited users/companies, accessibility from anywhere, no need for additional hardware/software, customizability, and scalability. DreamApps offers a comprehensive set of application modules and guarantees a 100% fit or refund.
3. Regulations and Regulators
Europe – Directive 2003/94/EC (EU
Regulators)
◦ GMP: “the part of quality assurance which ensures
that products are consistently produced and
controlled in accordance with the quality standards
appropriate to their intended use”
USA – F,D&C Act, Federal Codes (FDA)
◦ “… the minimum current good manufacturing
practice for … the manufacture, processing,
packing, or holding of a drug to assure [safety,
identity, strength, quality and purity]”
4. The GxP’s
“Good x Practice”
◦ Good Clinical Practice
◦ Good Distribution Practice
◦ Good Laboratory Practice
◦ Good Manufacturing Practice
GxP Controls to are required to minimize
risks to
◦ Patient Safety
◦ Product Quality
◦ Data Integrity
5. Objective
“Our primary focus will remain the same:
to minimize the risks to the public health”
- Department of Health and Human
Services, U.S. Food and Drug
Administration
6. Laws, Regulations and Guidance
Law, e.g.
◦ Food, Drug & Cosmetic Act, EU Directive
Regulations, e.g.
◦ 21 CFR 211, 21 CFR 820, EU GMPs
Guidance, e.g.
◦ FDA Guidance on Part 11 Scope and Application
7. The Food, Drug and Cosmetic Act
“A drug or device shall be deemed to be
adulterated … if it is a drug and the methods
used in, or the facilities or controls and the
methods used in, or the facilities or controls used
for, its manufacture, processing, packing, or
holding do not conform to or are not operated or
administered in conformity with current good
manufacturing practice to assure that such drugs
meet the requirements of this chapter as to
safety and has the identity and strength, and
meet the quality and purity characteristics, which
it purports or is represented to possess…”
8. 21 CFR 211.68 Automatic,
Mechanical and Electronic
Equipment
Must
◦ Perform a function satisfactorily
◦ Calibrated, inspected or checked according to a
written programme
◦ Controlled in use
◦ The data is secure
◦ Outputs are accurate
◦ Adequately backed up, maintained and
documented
◦ Under change control
9. GAMP 5, ICH Q9
“Manufacturers should be able to justify
their standards, protocols, acceptance
criteria, procedures and records based on
their risk assessment”
11. Records and Signatures
Records that are required to be maintained under
predicate rule requirements and that are maintained
in electronic format in place of paper format
Records that are required to be maintained under
predicate rules that are maintained in electronic
format in addition to paper format, and that are relied
upon to perform regulated activities
Records submitted to FDA under predicate rules
(even if such records are not specifically identified in
Agency regulations) in electronic format.
◦ - FDA Scope and Application Guidance
12. Elecronic Record
Electronic record means any combination
of text, graphics, data, audio, pictorial or
other information representation in digital
form that is created, modified,
maintained, archived, retrieved, or
distributed by a computer system
13. Electronic Signature
Electronic signature means a computer
data compilation of any symbol or series
of symbols executed, adopted, or
authorized by an individual to be the
legally binding equivalent of the
individual’s handwritten signature
14. Validation of Systems
Validation of systems to ensure accuracy,
reliability, consistent intended
performance and the reliability to discern
invalid or altered records
This clause is currently under enforcement
discretion
15. Protection
Protection of records to ensure their
accurate and ready retrieval throughout
the records retention period
16. Record Retention
Must meet predicate rule requirements
and preserve content and meaning
Decision how should be based on
predicate requirements, a justified and
documented risk assessment, and
determination of the value of the records
over time
17. Audit Trail
Secure, computer generated timestamped
audit trails to independently record the
date and time of operator entries and
actions that create, modify or delete
electronic records
18. Quality Management System
Quality Modules
• Risk Management
• Document Management
• Project Management
• Process Management
• IT Services Management
• Product Life Cycle Mgt
• Competency
Management
• Asset Management
• Preventive/Corrective
Actions
• etc
19. ERP
ERP Functions
◦ General Ledger
◦ Purchasing
◦ Inventory
◦ Sales
◦ Accounts Receivables
◦ Accounts Payables
◦ Production Planning & Control
Logistics
Production Schedule
Job Costing
◦ etc
20. Differences
Quality Management Systems ERP Systems
Data related to Quality Management
• Quality documents, policies, SOP,
procedures, checklist
• Project plans eg product lifecycle
management activities: prepare specs,
drawings, acceptance, tooling, training
• Quality related workflows
• Preventive/ corrective actions:
equipment maintenance, customer
complaints, incoming QC
• Risk management – identification,
quantification, control plan, monitoring
• Quality related KPIs – reworks,
downtime, deadlines
• Staff training – evaluation, training
needs, scheduling, certification
Financial, manufacturing and logistic data
• Order entry, deliveries, sales invoicing,
accounts receivables
• Purchase requisitions, purchase orders,
deliveries, accounts payables
• Cash and payment management, bank
reconciliation, cashflow reporting
• Manufacturing plans, production
scheduling
• Inventory management, receipts,
issuance, stock levels, transfers
• Facility management, fixed asset
register, acquisitions, disposals,
depreciation
• Human resource management, payroll,
taxes
21. Comparison of ERP to Quality
Management System
Quality Management Systems
complement ERP Systems
Quality Management Systems manages
quality documents, processes, people,
facilities and assets, materials
ERP systems manages accounting and
logistics aspects of finance, production,
inventories
29. Integration Points – Core Module
Personnel – staff/user id, departments,
teams, positions, roles
Business Units, Organization Units
Business Calendar
30. Process Integration – Sales/ Production
Predefined
Parts
Custom
Order
Production
Sales
Support
QMS ERP
• Specifications Docs
• Drawings
• Project Planning
• Specifications/
Drawings – Revision
Control/ Acceptance
• Commercial Proposal
Docs
• Change Management
• Quality Records
• Quality KPIs
• Process Risks
• Logistics Document
Capture/ Storage
• Corrective Actions
• Parts Definitions
• Parts Details/ Std
Costs
• Sales Quotation
• Order Entry
• Subcontractors
Quotations
• Credit Control
• Production Planning/
Control
• Inventory
• Cost Accounting
• Delivery Order
• Invoicing
• Accounts Receivables
31. Integration Points - Production
Item types
Part numbers
Part details eg descriptive details, alias
names
Equipment ID
Process/ Run / Batch ID and details
Customer names and details
Subcontractor names and details (if
applicable)
35. Integration Points – Fixed Assets
Equipment ID and details
Supplier ID and details
Maintenance service providers ID and
details
Maintenance/ calibration records and
schedules