GB/T 22278-2008 English PDFUS$254.00 ยท In stock
Delivery: <= 3 days. True-PDF full-copy in English will be manually translated and delivered via email. GB/T 22278-2008: Principles of good laboratory practice Status: Valid
Basic dataStandard ID: GB/T 22278-2008 (GB/T22278-2008)Description (Translated English): Principles of good laboratory practice Sector / Industry: National Standard (Recommended) Classification of Chinese Standard: A00 Classification of International Standard: 03.120.20 Word Count Estimation: 13,187 Date of Issue: 2008-08-04 Date of Implementation: 2009-04-01 Adopted Standard: OECD GLP, IDT; ENVMCCHEM (98)17, IDT Regulation (derived from): Announcement of Newly Approved National Standards No. 12 of 2008 (No. 125 overall) Issuing agency(ies): General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China, Standardization Administration of the People's Republic of China Summary: This standard specifies the Good Laboratory Practices related terms and definitions, as well as the main technical specifications, including testing the organization and personnel, quality assurance programs, facilities, equipment, materials and reagents, test systems, test samples and reference, standard operating program, the implementation of the study, the findings of the reports, records and materials storage and safekeeping. This standard covers the principles stipulated in the non-clinical GLP health and environmental safety studies, including in the laboratory, greenhouse and field work carried out. In addition to national legislation explicitly exempted under this standard GLP principles apply to regulations required all non- clinical health and environmental safety studies, including pharmaceuticals, pesticides, food additives and feed additives, cosmetics, veterinary drugs and similar products registered or applied permits, and industrial chemicals management. GB/T 22278-2008: Principles of good laboratory practice---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.Principles of good laboratory practice ICS 03.120.20 A00 National Standards of People's Republic of China Principles of Good Laboratory Practice Posted 2008-08-04 2009-04-01 implementation Administration of Quality Supervision, Inspection and Quarantine of People's Republic of China Standardization Administration of China released ForewordThis standard is identical with the Organisation for Economic Co-operation and Development (OECD) Good Laboratory Practice (GLP) principles and a series of documents for compliance monitoring No. 1. "OECDGLP Principles" [ENV/MC/CHEM (98) 17]. This standard made the following editorial changes. --- Delete the original text of. (1) OECD background briefings; (2) Foreword and Introduction; (3) Part 2. Principles and comply with GLP Oversight of the OECD Council concerning the bill. This standard is managed by the National Standardization Technical Committee chemicals dangerous (SAC/TC251) and focal points. This standard drafting unit. Shandong CIQ. The main drafters of this standard. Zhang Shao Yan, Tao Qiang, Liu Xuehui by Ruihua, courtesy car East, Wan Min, yellow saffron. Principles of Good Laboratory Practice1 ScopeThis standard specifies the Good Laboratory Practice (GoodLaboratoryPractice, hereinafter referred to as GLP) related terms and definitions to And main technical specifications, including test organizations and personnel agencies, quality assurance programs, facilities, equipment, materials and reagents, test systems, test Report samples and reference standard operating procedures, the implementation of research findings, and the recording material storage and safekeeping. Non-clinical health and environmental safety studies covered by the principles of GLP specified in this standard, including the laboratory, greenhouse and field trials of jobs. Except as expressly exempted national legislation, the provisions of this standard GLP principles apply to all non-clinical health and the requirements in the regulations Environmental safety studies, including registration or apply for a license in medicine, pesticides, food additives and feed additives, cosmetics, veterinary drugs and similar products, And industrial chemicals management.2 Terms and definitionsThe following terms and definitions apply to this standard. 2.1 Good Laboratory Practice 2.1.1 It is planned to run relevant agencies and non-clinical health and environmental safety studies, implementation, operation conditions of supervision, recording, archiving and reporting A set of quality system. 2.2 The term of the pilot institutions and organizations 2.2.1 The implementation of non-clinical health and environmental safety studies required of staff, premises and operating unit. For multi-site studies, including the testing facility Project leader and all other places where the individual test sites, these sites, or from an individual point of view on the whole, can be called again Inspection agency. 2.2.2 Execution venues study one or more stages. 2.2.3 In accordance with GLP principles organization and operation of test bodies with administrative authority and is officially responsible for personnel. 2.2.4 (If the appointment of this post) to ensure that personnel responsible for its test site in the research phase in accordance with the principles of GLP execution. 2.2.5 Commission, support and (or) entity to submit non-clinical health and environmental safety studies. 2.2.6 Responsible for the overall implementation of a non-clinical health and environmental safety studies of people. ......Tips & Frequently Asked Questions:Question 1: How long will the true-PDF of GB/T 22278-2008_English be delivered?Answer: Upon your order, we will start to translate GB/T 22278-2008_English as soon as possible, and keep you informed of the progress. 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