Guidance For The Implementation Of A Quality Management System In Drug Testing Laboratories

The quality of analyses and results of drug analysis laboratories have significant implications for the justice system, law enforcement, crime prevention and health policy, as well as for the international harmonization and worldwide exchange and coordination of drug information and data. The document aims to provide guidance to deliver high quality in a forensic laboratory, use the appropriate techniques to find the "answers" and to improve it constantly. It is a "how to do document" and includes some areas that are not explicitly covered in depth by ISO 17025.

The quality of analyses and results of drug analysis laboratories have significant implications for the justice system, law enforcement, crime prevention and health policy, as well as for the international harmonization and worldwide exchange and coordination of drug information and data. The document aims to provide guidance to deliver high quality in a forensic laboratory, use the appropriate techniques to find the “answers” and to improve it constantly. It is a “how to do document” and includes some areas that are not explicitly covered in depth by ISO 17025.

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".

Chapter 1. Introduction -- chapter 2. Disease burden and 2015 targets assessment -- chapter 3. TB case notifications and treatment outcomes -- chapter 4. Drug-resistant TB -- chapter 5. Diagnostics and laboratory strengthening -- chapter 6. Addressing the co-epidemics of TB and HIV -- chapter 7. Financing -- chapter 8. Research and development -- Annexes.

Building upon the success of previous editions of the bestselling Handbook of Laboratory Animal Science, first published in 1994, this latest revision combines all three volumes in one definitive guide. It covers the essential principles and practices of Laboratory Animal Science as well as selected animal models in scientific disciplines where much progress has been made in recent years. Each individual chapter focuses on an important subdiscipline of laboratory animal science, and the chapters can be read and used as stand-alone texts, with only limited necessity to consult other chapters for information. With new contributors at the forefront of their fields, the book reflects the scientific and technological advances of the past decade. It also responds to advances in our understanding of animal behavior, emphasizing the importance of implementing the three Rs: replacing live animals with alternative methods, reducing the number of animals used, and refining techniques to minimize animal discomfort. This fourth edition will be useful all over the world as a textbook for laboratory animal science courses for postgraduate and undergraduate students and as a handbook for scientists who work with animals in their research, for university veterinarians, and for other specialists in laboratory animal science.

Based on the work of a collection of experts from the laboratory science and quality assurance fields, A Laboratory Quality Handbook of Best Practices and Relevant Regulations provides all of the information needed to run a successful laboratory that is in compliance with all regulations. From sample tracking to accurate documentation, training to methods validation, maintenance to calibration, and out-of-spec responses to preparation for audits, a combination of people, instrumentation and documentation must work in sync for high quality results. This handbook provides information that will help a laboratory achieve high quality results and compliance. Contents: Quality Assurance in the Laboratory, History of Regulation, Training in the Laboratory, Laboratory Documentation and Data, Sample Control and LIM Systems, Methods Validation