GB/T 22277-2008 English PDFUS$94.00 ยท In stock
Delivery: <= 3 days. True-PDF full-copy in English will be manually translated and delivered via email. GB/T 22277-2008: Advisory document for good laboratory practice -- The role and responsibilities of the sponsor in the application of the principles of GLP Status: Valid
Basic dataStandard ID: GB/T 22277-2008 (GB/T22277-2008)Description (Translated English): Advisory document for good laboratory practice -- The role and responsibilities of the sponsor in the application of the principles of GLP Sector / Industry: National Standard (Recommended) Classification of Chinese Standard: A00 Classification of International Standard: 03.120.20 Word Count Estimation: 5,573 Date of Issue: 2008-08-04 Date of Implementation: 2009-04-01 Quoted Standard: GB/T 22278-2008 Adopted Standard: OECD GLP, IDT; ENVMCCHEM (98)16, 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 applies to follow the principles of good laboratory practice tests and study for the tasks and responsibilities of the Principal 's requirements. When commissioned by a non-clinical health and environmental safety studies when Principal shall ensure that the test agency to follow the principles of GLP requirements to conduct research, and provide relevant information and characterization of chemical safety data. GB/T 22277-2008: Advisory document for good laboratory practice -- The role and responsibilities of the sponsor in the application of the principles of GLP---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. Advisory document for good laboratory practice. The role and responsibilities of the sponsor in the application of the principles of GLP ICS 03.120.20 A00 National Standards of People's Republic of China Good Laboratory Practice recommends that documents In the application of the principles of Good Laboratory Practice Roles and responsibilities of Principal 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. 11. "The application of the principal tasks and responsibilities GLP principles" [ENV/MC/CHEM (98) 16]. The standards for the following editorial changes. --- Remove the preamble of the original. 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. yellow flowers, pottery strong, Wang Xiaobing, at dawn, Yue Zhiqin, Yu Wen Lin. Good Laboratory Practice recommends that documents In the application of the principles of Good Laboratory Practice Roles and responsibilities of Principal1 ScopeThis standard applies to trials and studies carried out in accordance with good laboratory practice (GLP) principles for the tasks and responsibilities entrusted to parties begging. When commissioned a non-clinical health and environmental safety studies when the commissioning party should ensure that the test bodies to follow the principles of GLP requirements To conduct research and provide relevant information on chemical safety and characterization data.2 Normative referencesThe following documents contain provisions which, through reference in this standard and become the standard terms. For dated references, subsequent Amendments (not including errata content) or revisions do not apply to this standard, however, encourage the parties to the agreement are based on research Whether the latest versions of these documents. For undated reference documents, the latest versions apply to this standard. GB/T 22278-2008 principles of Good Laboratory Practice3 Terms and DefinitionsGB/T 22278-2008 The terms and definitions apply to this standard.4 Requirements4.1 Description Although the GB/T 22278-2008 merely clarified the research part of the duties of the Principal, Principal and some unspecified level Responsibility, because this is in fact the principal is often initiated by one or more research, and the results will be submitted directly to the management of people. Principal Should play an active role in the confirmation of all non-clinical health and environmental safety study whether the principles of compliance with GLP issues. Entrust Party can not rely solely on the guarantee contract testing organizations or institutions to implement these studies. Guidelines are given below describe the Principal shall fulfill It has a clear and undefined responsibilities. 4.2 Defining Principal means an entity that commission, support and (or) to submit a non-clinical health and environmental safety studies (see GB/T 22278- 2008 2.2.5. Note 1. The Client may include. Initiating a non-clinical health and environmental safety studies and provide support through financial or other resources of the entity. Submit a non-clinical health and environmental safety studies to management, to register for the product or other needs in line with the principles of GLP support applications Entities. Note 2. The "entity" may include one individual, partnership, business, association, scientific or academic institutions, government departments, or organizational unit in which, or on other legal Identifiable groups. 4.3 Liability of Principal Principal shall understand the requirements of GLP principles, particularly those responsible for people involved in the testing facility managers and project/program on behalf of duties Claim. NOTE. If you subcontract part of the study by the commission to the subcontractor, the client should understand the responsibility of the entire study is still borne by the person in charge of the project, including the original number According to the effectiveness and reporting. 4.4 When the health and environmental safety studies commissioned by a non-clinical time, the client should ensure that the testing facility to be able to follow the principles of GLP ......Tips & Frequently Asked Questions:Question 1: How long will the true-PDF of GB/T 22277-2008_English be delivered?Answer: Upon your order, we will start to translate GB/T 22277-2008_English as soon as possible, and keep you informed of the progress. The lead time is typically 1 ~ 3 working days. The lengthier the document the longer the lead time.Question 2: Can I share the purchased PDF of GB/T 22277-2008_English with my colleagues?Answer: Yes. 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