Download or read book OECD Series on Principles of Good Laboratory Practice and Compliance Monitoring Outsourcing of Inspection Functions by Glp Compliance Monitoring Authorities written by OECD and published by OECD Publishing. This book was released on 2014-09-03 with total page 4 pages. Available in PDF, EPUB and Kindle. Book excerpt: This document reiterates the decisions and the recommendations related to the role and responsibilities of governments, national GLP compliance monitoring authorities and inspectors with regard to outsourcing.
Download or read book OECD Series on Principles of Good Laboratory Practice and Compliance Monitoring The Application of the Principles of GLP to in vitro Studies written by OECD and published by OECD Publishing. This book was released on 2004-12-01 with total page 18 pages. Available in PDF, EPUB and Kindle. Book excerpt: This document facilitates the proper application and interpretation of the GLP Principles for the organisation and management of in vitro studies, and provides guidance for the appropriate application of the GLP Principles to in vitro studies.
Download or read book Good Laboratory Practice OECD Principles and Guidance for Compliance Monitoring written by OECD and published by OECD Publishing. This book was released on 2005-12-16 with total page 143 pages. Available in PDF, EPUB and Kindle. Book excerpt: This publication unites all of the OECD documents related to Good Laboratory Practice and compliance monitoring, and, in the Annex, reproduces the three OECD Council Decisions related to the Mutual Acceptance of Data in the Assessment of Chemicals.
Download or read book Good Laboratory Practice written by Organisation for Economic Co-operation and Development and published by Org. for Economic Cooperation & Development. This book was released on 2005 with total page 150 pages. Available in PDF, EPUB and Kindle. Book excerpt: Unites the OECD documents related to good laboratory practice and compliance monitoring, and, in the Annex, reproduces the three OECD Council Decisions related to the mutual acceptance of data in the assessment of chemicals.
Download or read book OECD Series on Principles of Good Laboratory Practice and Compliance Monitoring Establishment and Control of Archives that Operate in Compliance with the Principles of GLP written by OECD and published by OECD Publishing. This book was released on 2007-06-11 with total page 24 pages. Available in PDF, EPUB and Kindle. Book excerpt: This document provides guidance concerning the establishment and control of archives compliant with the principles of Good Laboratory Practice, and is intended for use by test facilities, contract archives and quality assurance units and comliance authorities.
Download or read book Regulating Medicines in a Globalized World written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2020-04-25 with total page 169 pages. Available in PDF, EPUB and Kindle. Book excerpt: Globalization is rapidly changing lives and industries around the world. Drug development, authorization, and regulatory supervision have become international endeavors, with most medicines becoming global commodities. Drug companies utilize global supply chains that often include facilities in countries with inconsistent regulations from those of the United States, perform pivotal trials in multiple countries to support registration submissions in various jurisdictions, and subsequently market their medicines throughout most of the world. These companies operate across borders and require individual national regulators to ensure that drugs authorized for use in their countries are safe and effective, and appropriate for their health care system and their population. This process involves significant resources and often duplicative work. It is important to consider how this process can be improved in order to better allocate resources, time, and efforts to improve public health. Regulating Medicines in a Globalized World: The Need for Increased Reliance Among Regulators considers the role of mutual recognition and other reliance activities among regulators in contributing to enhancing public health. This report identifies opportunities for leveraging reliance activities more broadly in order to potentially impact public health globally. Key topics in this report include the job of medicines regulators in today's world, what policy makers need to know about today's regulatory environment, stakeholder views of recognition and reliance, as well as removing impediments and facilitating action for greater recognition and reliance among regulatory authorities.
Download or read book OECD Due Diligence Guidance for Responsible Supply Chains in the Garment and Footwear Sector written by OECD and published by OECD Publishing. This book was released on 2018-03-07 with total page 192 pages. Available in PDF, EPUB and Kindle. Book excerpt: The OECD Due Diligence Guidance for Responsible Supply Chains in the Garment and Footwear Sector helps enterprises implement the due diligence recommendations contained in the OECD Guidelines for Multinational Enterprises along the garment and footwear supply chain.
Download or read book Data Integrity and Data Governance written by R. D. McDowall and published by Royal Society of Chemistry. This book was released on 2018-11-09 with total page 660 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book provides practical and detailed advice on how to implement data governance and data integrity for regulated analytical laboratories working in the pharmaceutical and allied industries.
Download or read book The OECD Principles of Good Laboratory Practice written by and published by . This book was released on 1992 with total page 36 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Good Research Practice in Non Clinical Pharmacology and Biomedicine written by Anton Bespalov and published by Springer Nature. This book was released on 2020-01-01 with total page 424 pages. Available in PDF, EPUB and Kindle. Book excerpt: This open access book, published under a CC BY 4.0 license in the Pubmed indexed book series Handbook of Experimental Pharmacology, provides up-to-date information on best practice to improve experimental design and quality of research in non-clinical pharmacology and biomedicine.
Download or read book A Practical Approach to Pharmaceutical Policy written by Andreas Seiter and published by World Bank Publications. This book was released on 2010-06-17 with total page 240 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book offers policy makers a hands-on approach, tested in the World Bank’s field work in many countries, for developing policies that improve access to safe, effective medicines in health systems of low- and middle-income economies.
Download or read book Technical Report Series written by and published by . This book was released on 1950 with total page 208 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Risk Assessment of Chemicals An Introduction written by C.J. van Leeuwen and published by Springer Science & Business Media. This book was released on 2007-09-18 with total page 706 pages. Available in PDF, EPUB and Kindle. Book excerpt: At last – a second edition of this hugely important text that reflects the progress and experience gained in the last decade and aims at providing background and training material for a new generation of risk assessors. The authors offer an introduction to risk assessment of chemicals as well as basic background information on sources, emissions, distribution and fate processes for the estimation of exposure of plant and animal species in the environment and humans exposed via the environment, consumer products, and at the workplace. The coverage describes the basic principles and methods of risk assessment within their legislative frameworks (EU, USA, Japan and Canada).
Download or read book Lateral Flow Immunoassay written by Raphael Wong and published by Springer Science & Business Media. This book was released on 2008-12-16 with total page 224 pages. Available in PDF, EPUB and Kindle. Book excerpt: Due to the simplicity, relative accuracy, fast result reporting, and user-friendliness of lateral flow immunoassay, its use has undergone tremendous growth in the diagnostic industry in the last few years. Such technology has been utilized widely and includes pregnancy and woman's health determination, cardiac and emergency conditions monitoring and testing, infectious disease including Flu screening, cancer marker screening, and drugs abuse testing. This book covers the scope of utilization, the principle of the technology, the patent concerns, information on the development and production of the test device and specific applications will be of interest to the diagnostic industry and the general scientific community.
Download or read book Ensuring Quality to Gain Access to Global Markets written by Martin Kellermann and published by World Bank Publications. This book was released on 2019-04-09 with total page 275 pages. Available in PDF, EPUB and Kindle. Book excerpt: In a modern world with rapidly growing international trade, countries compete less based on the availability of natural resources, geographical advantages, and lower labor costs and more on factors related to firms' ability to enter and compete in new markets. One such factor is the ability to demonstrate the quality and safety of goods and services expected by consumers and confirm compliance with international standards. To assure such compliance, a sound quality infrastructure (QI) ecosystem is essential. Jointly developed by the World Bank Group and the National Metrology Institute of Germany, this guide is designed to help development partners and governments analyze a country's quality infrastructure ecosystems and provide recommendations to design and implement reforms and enhance the capacity of their QI institutions.
Download or read book Regulated Bioanalysis Fundamentals and Practice written by Mario L. Rocci Jr. and published by Springer. This book was released on 2017-04-24 with total page 239 pages. Available in PDF, EPUB and Kindle. Book excerpt: The editors have engaged leading scientists in the field to participate in the development of this book, which is envisioned as a “one of a kind” contribution to the field. The book is a comprehensive text that puts fundamental bioanalytical science in context with current practice, its challenges and ongoing developments. It expands on existing texts on the subject by covering regulated bioanalysis of both small and large molecule therapeutics from both a scientific and regulatory viewpoint. The content will be useful to a wide spectrum of readers: from those new to bioanalysis; to those developing their experience in the laboratory, or working in one of the many critical supporting roles; to seasoned practitioners looking for a solid source of information on this exciting and important discipline.
Download or read book Biodegradability of Surfactants written by D.R. Karsa and published by Springer Science & Business Media. This book was released on 1994-12-31 with total page 278 pages. Available in PDF, EPUB and Kindle. Book excerpt: The awareness and development of 'biodegradable' surfactants pre-dates current pressures by the environmental movement by nearly three decades, wherein a responsible industry mutually agreed to replace 'hard', non-biodegradable com ponents of household detergents by 'soft', biodegradable alternatives, without course to legislation. The only requirement at that time was for surfactants used in detergents to exhibit a 'primary biodegradability' in excess of 80%; this referring to the disap pearance or removal from solution of the intact surface active material as de tected by specified analytical techniques. This proved useful, as observed environmental impacts of surfactants, e.g. visible foam on rivers, are associated with the intact molecule. Test methods for 'primary biodegradability' were eventually enshrined in EU legislation for nonionic surfactants (Directive 821242/EEC, amended 73/404IEEC) and for anionic surfactants (Directive 8212431EEC, amended 73/405IEEC). No approved test methods and resultant legislation have been developed for cationic and amphoteric surfactants to date. The environmental classification of chemical substances, which of course includes surfactants, and associated risk assessment utilises a second criterion 'ready biodegradability'. This may be assessed by a number of methods which monitor oxygen uptake (BOD), carbon dioxide production or removal of dis solved organic carbon (DOC). Some surfactants which comply with the above Detergents Directive are borderline when it comes to 'ready biodegradability'.