Download or read book Quality Control Applications in the Pharmaceutical and Medical Device Manufacturing Industry written by Eugenia Gabriela Carrillo-Cedillo and published by . This book was released on 2022 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt: "This book gives the reader an up-to-date overview of the medical device manufacturing process and its influence on current regulations highlighting the importance of quality control in pharmaceutical products and medical devices, which must have very high-quality standards so as not to cause problems to the health of patients"--

Download or read book Quality Control and Evaluation of Herbal Drugs written by Pulok K. Mukherjee and published by Elsevier. This book was released on 2019-05-30 with total page 788 pages. Available in PDF, EPUB and Kindle. Book excerpt: Quality Control and Evaluation of Herbal Drugs brings together current thinking and practices for evaluation of natural products and traditional medicines. The use of herbal medicine in therapeutics is on the rise in both developed and developing countries and this book facilitates the necessary development of quality standards for these medicines.This book elucidates on various challenges and opportunities for quality evaluation of herbal drugs with several integrated approaches including metabolomics, chemoprofiling, marker analysis, stability testing, good practices for manufacturing, clinical aspects, Ethnopharmacology and Ethnomedicine inspired drug development. Written by Prof. Pulok K Mukherjee, a leader in this field; the book highlights on various methods, techniques and approaches for evaluating the purity, quality, safety and efficacy of herbal drugs. Particular attention is paid to methods that assess these drugs' activity, the compounds responsible and their underlying mechanisms of action. The book describes the quality control parameters followed in India and other countries, including Japan, China, Bangladesh, and other Asian countries, as well as the regulatory profiles of the European Union and North America. This book will be useful in bio-prospecting of natural products and traditional medicine-inspired drug discovery and development. - Provides new information on the research and development of natural remedies - essential reading on the study and use of natural resources for preventative or healing purposes - Brings together current thinking and practices in quality control and standardization of herbal drugs highlighting several integrated approaches for metabolomics, chemo-profiling and marker analysis - Aids in developing knowledge of various techniques including macroscopy, microscopy, HPTLC, HPLC, LC-MS/MS, GC-MS etc. with the development of integrated methods for evaluation of botanicals used in traditional medicine - Assessment of herbal drugs through bio-analytical techniques, bioassay guided isolation, enzyme inhibition, pharmacological, microbiological, antiviral assays and safety related quality issues - References global organizations, such as the WHO, USFDA, CDSCO, AYUSH, TCM and others to serve as a comprehensive document for enforcement agencies, NGOs and regulatory authorities

Download or read book Basic Tests for Drugs written by World Health Organization and published by World Health Organization. This book was released on 1998 with total page 104 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book provides a step-by-step guide to simple methods for verifying the identity of commonly used pharmaceutical substances and dosage forms. The basic tests described can also be used to detect mislabeled, substandard, or counterfeit products when the labeling or physical attributes give rise to doubt. Intended for use in developing countries, where resources and specialized skills may be scarce, all tests rely on a limited range of easily available reagents and equipment and need not be performed in a fully equipped laboratory or by persons with specialized training in pharmacy or chemistry. The book describes tests for 23 pharmaceutical substances and 58 pharmaceutical dosage forms, most of which are included in the WHO Model List of Essential Drugs. Basic tests for confirming the identity of four commonly used medicinal plant materials are also included. As stressed in the text, these tests, which merely confirm identity, are intended for use as primary screening tools and may need to be followed, in cases of adverse test results, by a full pharmacopoeial analysis. The book opens with a brief description of the importance of basic tests as one of the many steps needed to ensure a supply of safe and effective drugs. Chapter two describes several collections of more sophisticated tests, including volumetric or spectrophotometric analysis and thin-layer chromatography, that can be useful in the primary screening of imported pharmaceutical substances, and dosage forms. Information on how to obtain and use these guides to tests, which have not been published by WHO is also provided. Against this background, the main part of the book sets out test procedures for verifying the identity of selected pharmaceutical substances, pharmaceutical dosage forms, and medicinal plant materials. The book concludes with a cumulative index of test procedures described here and in the related WHO publications "Basic Tests for Pharmaceutical Substances" and "Basic Tests for Pharmaceutical Dosage Forms".

Download or read book An Introduction to Quality Assurance in Health Care written by Avedis Donabedian and published by Oxford University Press. This book was released on 2002-12-26 with total page 233 pages. Available in PDF, EPUB and Kindle. Book excerpt: Avedis Donabedian's name is synonymous with quality of medical care. He unraveled the mystery behind the concept by defining it in clear operational terms and provided detailed blueprints for both its measurement(known as quality assessment) and its improvement(known as quality assurance). Many before him claimed that quality couldn't be defined in concrete objective terms. He demonstrated that quality is an attribte of a system which he called structure, a set of organized activities whihc he called process, and an outcome which results from both. In this book Donabedian tells the full story of quality assessment and assurance in simple, clear terms. He defines the meaning of quality, explicates its components, and provides clear and systematic guides to its assessment and enhancement. His style is lucid, succinct, systematic and yet personal, almost conversational.

Download or read book Quality Systems and Controls for Pharmaceuticals written by Dipak Kumar Sarker and published by John Wiley & Sons. This book was released on 2008-07-31 with total page 204 pages. Available in PDF, EPUB and Kindle. Book excerpt: Quality Systems and Control for Pharmaceuticals is an accessible overview of the highly-regulated area of pharmaceutical manufacture, the production of biomedical materials, and biomedical devices. Introducing the subject in a clear and logical manner it enables the reader to grasp the key concepts of the multidisciplinary area of control science and specifically quality control using industrial and theoretical models. Taking a multidisciplinary approach to the subject the reader is guided through key topics such as product safety which takes into account aspects of analytical science, statistics, microbiology, biotechnology, engineering, business practice and optimizing models, the law and safeguarding public health, innovation and inventiveness and contemporary best practice. The author has both industry and academic experience and many ‘best practice’ examples are included throughout the text based on his own industry experience and current practicing industrial pharmacists. This is an invaluable reference for all students of pharmacy who may have little or no familiarity with industrial practice and for those studying BSc chemistry, biomedical sciences, process analytical chemistry and MSc in Industrial Practice.

Download or read book Registries for Evaluating Patient Outcomes written by Agency for Healthcare Research and Quality/AHRQ and published by Government Printing Office. This book was released on 2014-04-01 with total page 385 pages. Available in PDF, EPUB and Kindle. Book excerpt: This User’s Guide is intended to support the design, implementation, analysis, interpretation, and quality evaluation of registries created to increase understanding of patient outcomes. For the purposes of this guide, a patient registry is an organized system that uses observational study methods to collect uniform data (clinical and other) to evaluate specified outcomes for a population defined by a particular disease, condition, or exposure, and that serves one or more predetermined scientific, clinical, or policy purposes. A registry database is a file (or files) derived from the registry. Although registries can serve many purposes, this guide focuses on registries created for one or more of the following purposes: to describe the natural history of disease, to determine clinical effectiveness or cost-effectiveness of health care products and services, to measure or monitor safety and harm, and/or to measure quality of care. Registries are classified according to how their populations are defined. For example, product registries include patients who have been exposed to biopharmaceutical products or medical devices. Health services registries consist of patients who have had a common procedure, clinical encounter, or hospitalization. Disease or condition registries are defined by patients having the same diagnosis, such as cystic fibrosis or heart failure. The User’s Guide was created by researchers affiliated with AHRQ’s Effective Health Care Program, particularly those who participated in AHRQ’s DEcIDE (Developing Evidence to Inform Decisions About Effectiveness) program. Chapters were subject to multiple internal and external independent reviews.

Download or read book Laboratory quality control and patient safety written by Jeremie M. Gras and published by Walter de Gruyter GmbH & Co KG. This book was released on 2017-03-06 with total page 105 pages. Available in PDF, EPUB and Kindle. Book excerpt: Every clinical laboratory devotes considerable resources to Quality Control. Recently, the advent of concepts such as Analytical Goals, Biological Variation, Six Sigma and Risk Management has generated a renewed interest in the way to perform QC. However, laboratory QC practices remain highly non-standardized and a lot of QC questions are left unanswered. The objective of this book is to propose a roadmap for the application of an integrated QC protocol that ensures the safety of patient results in the everyday lab routine.

Download or read book Handbook of Microbiological Quality Control in Pharmaceuticals and Medical Devices written by Rosamund M. Baird and published by CRC Press. This book was released on 2000-08-17 with total page 274 pages. Available in PDF, EPUB and Kindle. Book excerpt: Microbiologists working in both the pharmaceutical and medical device industries, face considerable challenges in keeping abreast of the myriad microbiological references available to them, and the continuously evolving regulatory requirements. The Handbook of Microbiological Quality Control provides a unique distillation of such material, by provi

Download or read book Improving Healthcare Quality in Europe Characteristics Effectiveness and Implementation of Different Strategies written by OECD and published by OECD Publishing. This book was released on 2019-10-17 with total page 447 pages. Available in PDF, EPUB and Kindle. Book excerpt: This volume, developed by the Observatory together with OECD, provides an overall conceptual framework for understanding and applying strategies aimed at improving quality of care. Crucially, it summarizes available evidence on different quality strategies and provides recommendations for their implementation. This book is intended to help policy-makers to understand concepts of quality and to support them to evaluate single strategies and combinations of strategies.

Download or read book Crossing the Quality Chasm written by Institute of Medicine and published by National Academies Press. This book was released on 2001-07-19 with total page 359 pages. Available in PDF, EPUB and Kindle. Book excerpt: Second in a series of publications from the Institute of Medicine's Quality of Health Care in America project Today's health care providers have more research findings and more technology available to them than ever before. Yet recent reports have raised serious doubts about the quality of health care in America. Crossing the Quality Chasm makes an urgent call for fundamental change to close the quality gap. This book recommends a sweeping redesign of the American health care system and provides overarching principles for specific direction for policymakers, health care leaders, clinicians, regulators, purchasers, and others. In this comprehensive volume the committee offers: A set of performance expectations for the 21st century health care system. A set of 10 new rules to guide patient-clinician relationships. A suggested organizing framework to better align the incentives inherent in payment and accountability with improvements in quality. Key steps to promote evidence-based practice and strengthen clinical information systems. Analyzing health care organizations as complex systems, Crossing the Quality Chasm also documents the causes of the quality gap, identifies current practices that impede quality care, and explores how systems approaches can be used to implement change.

Download or read book Assuring Data Quality and Validity in Clinical Trials for Regulatory Decision Making written by Institute of Medicine and published by National Academies Press. This book was released on 1999-07-27 with total page 88 pages. Available in PDF, EPUB and Kindle. Book excerpt: In an effort to increase knowledge and understanding of the process of assuring data quality and validity in clinical trials, the IOM hosted a workshop to open a dialogue on the process to identify and discuss issues of mutual concern among industry, regulators, payers, and consumers. The presenters and panelists together developed strategies that could be used to address the issues that were identified. This IOM report of the workshop summarizes the present status and highlights possible strategies for making improvements to the education of interested and affected parties as well as facilitating future planning.

Download or read book A Practical Guide to Quality Management in Clinical Trial Research written by Graham Ogg and published by CRC Press. This book was released on 2005-11-01 with total page 229 pages. Available in PDF, EPUB and Kindle. Book excerpt: Setting up a GXP environment where none existed previously is a very daunting task. Getting staff to write down what they do for every task is a correspondingly difficult and time-consuming exercise. Examining how to maintain quality control in clinical trial research, A Practical Guide to Quality Management in Clinical Trial Research provides a co

Download or read book Quality in Nuclear Medicine written by Andor W.J.M. Glaudemans and published by Springer. This book was released on 2016-11-14 with total page 455 pages. Available in PDF, EPUB and Kindle. Book excerpt: This comprehensive textbook provides a state of the art overview of the means by which quality in patient care is ensured within the field of nuclear medicine. Acknowledged experts in the field cover both management aspects, such as laws, standards, guidelines, patient safety, management instruments, and organisations, and specific issues, including radiation safety and equipment. Quality in Nuclear Medicine not only presents detailed information on the topics discussed but should also stimulate further discussion and offer an important tool to all professionals in the field of nuclear medicine and their stakeholders. Readers will find that the book provides a wealth of excellent guidance and reflects the pioneering role of nuclear medicine in advancing different aspects of quality within medicine.

Download or read book Medicare written by Institute of Medicine and published by National Academies Press. This book was released on 1990-02-01 with total page 462 pages. Available in PDF, EPUB and Kindle. Book excerpt: Health care for the elderly American is among our nation's more pressing social issues. Our society wishes to ensure quality health care for all older people, but there is growing concern about our ability to maintain and improve quality in the face of efforts to contain health care costs. Medicare: A Strategy for Quality Assurance answers the U.S. Congress' call for the Institute of Medicine to design a strategic plan for assessing and assuring the quality of medical care for the elderly. This book presents a proposed strategic plan for improving quality assurance in the Medicare program, along with steps and timetables for implementing the plan by the year 2000 and the 10 recommendations for action by Congress. The book explores quality of careâ€"how it is defined, measured, and improvedâ€"and reviews different types of quality problems. Major issues that affect approaches to assessing and assuring quality are examined. Medicare: A Strategy for Quality Assurance will be immediately useful to a wide audience, including policymakers, health administrators, individual providers, specialists in issues of the older American, researchers, educators, and students.

Download or read book Concepts of Quality Management in Pharmaceutical Industry written by Manohar A Potdar and published by Pharmamed Press. This book was released on 2017-08-08 with total page 280 pages. Available in PDF, EPUB and Kindle. Book excerpt: In managing the Quality, why we do something is more important than what we do. The purpose of this book is to explain this basis of Quality management to those who need to know in pharmaceutical industry. This book explains the above view with reference to pharma industry with the help of principles of quality advocated by the genius like Dr. Joseph Juran in simple to understand language. The book will be very useful to the postgraduate students of pharmacy and practicing quality managers in pharma industry.

Download or read book Laboratory Quality Management System written by World Health Organization and published by . This book was released on 2011 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: Achieving, maintaining and improving accuracy, timeliness and reliability are major challenges for health laboratories. Countries worldwide committed themselves to build national capacities for the detection of, and response to, public health events of international concern when they decided to engage in the International Health Regulations implementation process. Only sound management of quality in health laboratories will enable countries to produce test results that the international community will trust in cases of international emergency. This handbook was developed through collaboration between the WHO Lyon Office for National Epidemic Preparedness and Response, the United States of America Centers for Disease Control and Prevention (CDC) Division of Laboratory Systems, and the Clinical and Laboratory Standards Institute (CLSI). It is based on training sessions and modules provided by the CDC and WHO in more than 25 countries, and on guidelines for implementation of ISO 15189 in diagnostic laboratories, developed by CLSI. This handbook is intended to provide a comprehensive reference on Laboratory Quality Management System for all stakeholders in health laboratory processes, from management, to administration, to bench-work laboratorians. This handbook covers topics that are essential for quality management of a public health or clinical laboratory. They are based on both ISO 15189 and CLSI GP26-A3 documents. Each topic is discussed in a separate chapter. The chapters follow the framework developed by CLSI and are organized as the "12 Quality System Essentials".

Download or read book Quality Assurance for Radioactivity Measurement in Nuclear Medicine written by International Atomic Energy Agency and published by IAEA. This book was released on 2006 with total page 108 pages. Available in PDF, EPUB and Kindle. Book excerpt: This publication contains information on the implementation of quality assurance and quality control programmes for measuring radioactivity relating to the practice of nuclear medicine, covering standards at both the end user (clinic) and secondary radioactivity standards laboratory levels. It is based on the QA principles in ISO/IEC 17025 which describes requirements that testing and calibration laboratories must meet to demonstrate that they have a quality system in place and are technically competent.