GB/T 22272-2008 English PDFUS$234.00 ยท In stock
Delivery: <= 3 days. True-PDF full-copy in English will be manually translated and delivered via email. GB/T 22272-2008: Advisory document for good laboratory practice: Establishment and control of archives that operate in compliance with the principles of GLP Status: Valid
Basic dataStandard ID: GB/T 22272-2008 (GB/T22272-2008)Description (Translated English): Advisory document for good laboratory practice: Establishment and control of archives that operate in compliance with the principles of GLP Sector / Industry: National Standard (Recommended) Classification of Chinese Standard: A00 Classification of International Standard: 03.120.20 Word Count Estimation: 12,152 Date of Issue: 2008-08-04 Date of Implementation: 2009-04-01 Quoted Standard: GB/T 22278-2008 Adopted Standard: OECD GLP, IDT; OECD ENVJMMONO (2007)10, 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 GLP testing facility, signing files, contract quality assurance or information technology services and the commissioning party, as well as GLP compliance monitoring authorities and receiving department. Trial-related organizations should ensure that control their business needs, to assess the applicable regulatory requirements. File components and some aspects of the operation, may be associated with the establishment of public health and safety regulations or laws related to these areas are not within the scope of this standard. Testing agencies and other organizations on the implementation of GLP file records and materials management, from the use of approved standard file management benefit, including those associated metadata. GB/T 22272-2008: Advisory document for good laboratory practice: Establishment and control of archives that operate in compliance with 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. Establishment and control of archives that operate in compliance with the principles of GLP ICS 03.120.20 A00 National Standards of People's Republic of China Good Laboratory Practice recommends that documents Establishment and management of compliance with good laboratory Principle of specification file 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. 15. "file creation and management in line with GLP principles" [OECDENV/JM/MONO (2007) 10, the English version]. This standard made the following editorial changes. --- Delete the original text of the OECD Background and Introduction. This standard is managed by the National Standardization Technical Committee chemicals dangerous (SAC/TC251) and focal points. This standard was drafted. Chinese Academy of Inspection and Quarantine, China Petroleum and Chemical Industry Association. Drafters of this standard. Falls Apart, Yu Wen Lin, Wang Xiaobing, Mei Jian, Sun Xin. Good Laboratory Practice recommends that documents Establishment and management of compliance with good laboratory Principle of specification file1 IntroductionA non-clinical health and environmental safety studies are archived material and recording production, is in line with the principles of Good Laboratory Practices Important content. Save the original sample data and research related to specific research produced, it is the only way to reproduce the research process, verifiable final Information in the report, and confirmed that studies with GLP requirements. The standard test is designed to help institutions to file management in line with the principles of Good Laboratory Practice requirements. This standard does not replace national regulations and/or laws related requirements, such as the period of record-keeping requirements.2 rangeThis standard applies to follow the testing facility GLP principles, signing archives, contract quality assurance or information technology (IT) services and the Commission Care party, as well as GLP compliance supervision departments and receiving department. Trial-related organizations, should ensure that control their business needs to assess the applicable regulatory requirements. Construction and operation of a file Some aspects may be related to the establishment of public health and safety rules or laws related to these aspects are not within the scope of this standard. Test institutions and other organizations to implement GLP archives and records management material, can benefit from the use of approved records management standard, Including those associated metadata.3 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 Practice4 Terms and DefinitionsThe following terms and definitions apply to this standard. 4.1 For secure storage and preservation of records and materials designated areas or facilities (such as file cabinets, room, building or electronic systems). 4.2 Personnel management in the file manager, and is responsible for the daily management of archives. 4.3 Assigned by the testing facility manager or test site manager, responsible for records management, as responsible for operating and program archives. 4.4 In accordance with the requirements of GLP principles, institutions and test systems save electronic records. ......Tips & Frequently Asked Questions:Question 1: How long will the true-PDF of GB/T 22272-2008_English be delivered?Answer: Upon your order, we will start to translate GB/T 22272-2008_English as soon as possible, and keep you informed of the progress. The lead time is typically 1 ~ 3 working days. 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