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Author: World Health Organization
Publisher:
ISBN: 9789241548274
Category : Laboratories
Languages : en
Pages : 0
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Book Description
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".
Author: World Health Organization
Publisher:
ISBN: 9789241548274
Category : Laboratories
Languages : en
Pages : 0
Get Book Here
Book Description
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".
Author:
Publisher: United Nations Publications
ISBN:
Category : Business & Economics
Languages : en
Pages : 76
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Book Description
The validation of analytical methods and the calibration of equipment are important aspects of quality assurance in the laboratory. This manual deals with both of these within the context of testing of illicit drugs in seized materials and biological specimens. It provides an introduction and practical guidance to national authorities and analysts in the implementation of method validation and verification, and also in the calibration/performance verification of laboratory instrumentation and equipment within their existing internal quality assurance programmes. The procedures described represent a synthesis of the experience of scientists from several reputable laboratories around the world.
Author:
Publisher:
ISBN:
Category :
Languages : en
Pages : 76
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Book Description
Author: Sarfaraz K. Niazi
Publisher: CRC Press
ISBN: 1482226383
Category : Medical
Languages : en
Pages : 992
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Book Description
As the generic pharmaceutical industry continues to grow and thrive, so does the need to conduct adequate, efficient bioequivalence studies. In recent years, there have been significant changes to the statistical models for evaluating bioequivalence. In addition, advances in the analytical technology used to detect drug and metabolite levels have m
Author: Andrew Teasdale
Publisher: John Wiley & Sons
ISBN: 1118971116
Category : Medical
Languages : en
Pages : 740
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Book Description
Examining the implications and practical implementation of multi-disciplinary International Conference on Harmonization (ICH) topics, this book gives an integrated view of how the guidelines inform drug development strategic planning and decision-making. • Addresses a consistent need for interpretation, training, and implementation examples of ICH guidelines via case studies • Offers a primary reference point for practitioners addressing the dual challenge of interpretation and practical implementation of ICH guidelines • Uses case studies to help readers understand and apply ICH guidelines • Provides valuable insights into guidelines development, with chapters by authors involved in generating or with experience implementing the guidelines • Includes coverage of stability testing, analytical method validation, impurities, biotechnology drugs and products, and good manufacturing practice (GMP)
Author: Mahmoud Aljurf
Publisher: Springer Nature
ISBN: 3030644928
Category : Medical
Languages : en
Pages : 189
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Book Description
This open access book provides a concise yet comprehensive overview on how to build a quality management program for hematopoietic stem cell transplantation (HSCT) and cellular therapy. The text reviews all the essential steps and elements necessary for establishing a quality management program and achieving accreditation in HSCT and cellular therapy. Specific areas of focus include document development and implementation, audits and validation, performance measurement, writing a quality management plan, the accreditation process, data management, and maintaining a quality management program. Written by experts in the field, Quality Management and Accreditation in Hematopoietic Stem Cell Transplantation and Cellular Therapy: A Practical Guide is a valuable resource for physicians, healthcare professionals, and laboratory staff involved in the creation and maintenance of a state-of-the-art HSCT and cellular therapy program.
Author:
Publisher:
ISBN:
Category : Weights and measures
Languages : en
Pages : 368
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Book Description
Author: World Health Organization
Publisher: World Health Organization
ISBN: 9241547588
Category : Business & Economics
Languages : en
Pages : 271
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Book Description
The emergence of extensively drug-resistant strains of tuberculosis, especially in countries with a high prevalence of human immunodeficiency virus, is a serious threat to global public health and jeopardizes efforts to effectively control the disease. This publication offers updated recommendations for the diagnosis and management of drug-resistant tuberculosis in a variety of geographical, economic and social settings, and the recording of data that enables the monitoring and evaluation of programs.--Publisher's description.
Author: Susannah Davies
Publisher: Royal Society of Chemistry
ISBN: 1788018109
Category : Medical
Languages : en
Pages : 590
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Book Description
New designer drugs, access to databases, and changing availability of samples for analysis have changed the face of modern forensic toxicology in recent years. Forensic Toxicology: Drug Use and Misuse brings together the latest information direct from experts in each sub-field of the discipline providing a broad overview of current thinking and the most innovative approaches to case studies. The text begins with an in-depth discussion of pharmacoepidemiology, including information on the value of nationwide databases in forensic toxicology. The use and abuse of drugs in driving, sport and the workplace are then discussed by industry experts who are conducting case work in their field. Not only are new drug groups discussed (NPS), but also their constantly changing impact on drug legislation. Synthetic cannabinoids, khat and mephodrone are discussed in detail. Following a section devoted to legislation and defence, readers will find comprehensive chapters covering sample choice reflecting the increasing use of hair and oral fluid, and also the less commonly used sweat and nail analysis. New and old case examples are compared and contrasted in the final part of the book, which will enable readers to understand how drugs impact on each other and how the interpretative outcome of a case are dependent on many aspects. From use of pharmaceutical drugs in a clinical setting, through smart drugs to new psychoactive drugs, this book documents the wide range in which drugs today are abused. This book will be an essential resource for postgraduate students in forensic toxicology, and for researchers in forensic toxicology laboratories who need the latest data and knowledge.
Author: Martin D. Hynes
Publisher: CRC Press
ISBN: 1000654370
Category : Medical
Languages : en
Pages : 310
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Book Description
This Second Edition is an essential guide to preparing for FDA pre-approval inspections-taking into account current trends in FDA expectations and inspection activities, such as the GMPs of the 21st Century, quality systems-based approach to inspections, risk-based inspections, quality by design, process analytical technology, design space, etc. Th
