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GOST 31879-2012

ГОСТ 31879-2012

Principles of Good Laboratory Practice (GLP). Guides for compliance monitoring procedures for GLP Principles

Принципы надлежащей лабораторной практики (GLP). Руководство по процедурам мониторинга соответствия Принципам GLP

Status: Effective - Introduced for the first time. IUS 9-2013

This standard establishes the mechanisms and procedures to be followed when creating national programs and bodies for monitoring compliance with the principles of good laboratory practice, and also recommends the organization of an appropriate structure. To facilitate the process of mutual recognition of test data (results) produced for submission to the GLP Regulatory Authorities of countries that are both members and non-OECD members, it is important to harmonize the procedures adopted to monitor compliance with the principles of good laboratory practice and their comparability. accuracy so that national GLP Compliance Programs can be internationally acceptable. It should be emphasized that countries should adopt the GLP Principles and establish procedures for monitoring compliance with the GLP Principles based on national legal and administrative practices and priorities, for example, in the area of initial and subsequent coverage of chemical categories and types of testing. Since an individual country can create several compliance monitoring bodies for the GLP Principles based on its legal system for the control of chemicals, it can also create more than one compliance program for the GLP Principles

Настоящий стандарт устанавливает механизмы и процедуры, которым необходимо следовать при создании национальных программ и органов мониторинга соответствия Принципам надлежащей лабораторной практике, а также рекомендует организацию соответствующей структуры. Для содействия процессу взаимного признания данных (результатов) испытаний, произведенных для представления в Регулирующие Органы GLP стран, являющихся как членами, так и нечленами ОЭСР, имеет важное значение гармонизация процедур, принятых для мониторинга соответствия Принципам надлежащей лабораторной практики, а также сопоставимости их качества и точности, с тем чтобы национальные программы соответствия Принципам GLP могли быть приемлемыми на международном уровне. Следует подчеркнуть, что страны должны принимать Принципы GLP и устанавливать процедуры мониторинга соответствия Принципам GLP, основываясь на национальной правовой и административной практике и приоритетах, например, в области первоначального и последующего охвата категорий химических веществ и типов испытания. Так как отдельная страна может создавать несколько органов мониторинга соответствия Принципам GLP, основываясь на своей правовой системе, касающейся контроля химических веществ, она может также создавать и более одной программы соответствия Принципам GLP

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Format: Electronic (pdf/doc)

Approved: Federal Agency for Technical Regulation and Metrology, 12/27/2012

SKU: RUSS66005

Price: $329.67



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The Product is Contained in the Following Classifiers:

Construction (Max) » Standards » Other state standards used in construction » 03 Sociology. Services. Organization of firms and their management. Administration. Transport »

PromExpert » SECTION V. ENVIRONMENTAL PROTECTION. NATURE USE » I Environmental-legal and economic-legal mechanisms for environmental protection » 2 Economic regulation infield of environmental protection and nature management »

ISO classifier » 03 SOCIOLOGY. SERVICES ORGANIZATION AND MANAGEMENT OF COMPANIES. ADMINISTRATION. TRANSPORT » 03.120 Quality » 03.120.20 Certification of products and companies. Conformity assessment »

National standards » 03 SOCIOLOGY. SERVICES ORGANIZATION AND MANAGEMENT OF COMPANIES. ADMINISTRATION. TRANSPORT » 03.120 Quality » 03.120.20 Certification of products and companies. Conformity assessment »

ISO classifier » 13 ENVIRONMENTAL PROTECTION, HUMAN PROTECTION AGAINST ENVIRONMENTAL IMPACT. SECURITY » 13.020 Environmental protection » 13.020.20 Environmental Economics »

National standards » 13 ENVIRONMENTAL PROTECTION, HUMAN PROTECTION AGAINST ENVIRONMENTAL IMPACT. SECURITY » 13.020 Environmental protection » 13.020.20 Environmental Economics »


The Document is Referenced By:

GOST 33647-2015: Principles of good laboratory practice (GLP). Terms and definitions

R 1.2.3156-13: Evaluation of the toxicity and hazard of chemicals and their mixtures for human health

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