GB/T 22274.1-2008 English PDFUS$134.00 ยท In stock
Delivery: <= 3 days. True-PDF full-copy in English will be manually translated and delivered via email. GB/T 22274.1-2008: Guidance for Good Laboratory Practice (GLP) monitoring authorities -- Part 1: Guides for compliance monitoring procedures for good laboratory practice Status: Valid
Basic dataStandard ID: GB/T 22274.1-2008 (GB/T22274.1-2008)Description (Translated English): Guidance for Good Laboratory Practice (GLP) monitoring authorities -- Part 1: Guides for compliance monitoring procedures for good laboratory practice Sector / Industry: National Standard (Recommended) Classification of Chinese Standard: A00 Classification of International Standard: 03.120.20 Word Count Estimation: 7,771 Date of Issue: 2008-08-04 Date of Implementation: 2009-04-01 Quoted Standard: GB/T 22274.2; GB/T 22278 Adopted Standard: OCDEGD (95)66, 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 practice in supervision departments of administration, confidentiality, personnel and training, GLP compliance program audit testing facility inspections and follow-up studies, the appeals process. This section applies to the establishment in our country, GLP supervision departments. GB/T 22274.1-2008: Guidance for Good Laboratory Practice (GLP) monitoring authorities -- Part 1: Guides for compliance monitoring procedures for 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. Guidance for Good Laboratory Practice (GLP) monitoring authorities Part 1. Guides for compliance monitoring procedures for good laboratory practice ICS 03.120.20 A00 National Standards of People's Republic of China Good Laboratory Practice oversight Guide Part 1. Good Laboratory Practice Compliance Oversight Guide 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 ForewordGB/T 22274 "Good Laboratory Practice oversight Guide" is divided into three parts. --- Part 1. Good Laboratory Practice guidelines for compliance monitoring procedures; --- Part 2. perform laboratory inspections and study audits guidelines; --- Part 3. Guidelines for Good Laboratory Practice inspection reports. This section GB/T 22274 Part 1. This section is equivalent to using the Organisation for Economic Cooperation and Development (OECD) Good Laboratory Practice (GLP) principles and a series of documents for compliance monitoring No. 2. "Good Laboratory Practice oversight Guide. Revised GLP compliance oversight Guide" [OCDE/GD (95) 66]. This section includes the following editorial changes. --- Remove the original (1) Foreword and Introduction; (2) the second part. with GLP principles and compliance monitoring of the relevant OECD Council Council Bills. This part of the National Chemicals Management Standardization Technical Committee dangerous (SAC/TC251) and focal points. The drafting of this section. Shandong CIQ. The main drafters of this section. SONG Zhen dry, Liuxue Hui, Wang Xiaobing, at dawn. Good Laboratory Practice oversight Guide Part 1. Good Laboratory Practice Compliance Oversight Guide1 ScopeThis section GB/T 22274 specifies the administrative supervision departments of Good Laboratory Practice, confidentiality, personnel and training, GLP Compliance plan, follow-up test facility inspections and study audits, complaints procedures. This section applies to the territory of China established GLP supervision departments.2 Normative referencesThe following documents contain provisions which, through reference GB/T 22274 in this section constitute provisions of this section. For dated references Documents, all subsequent amendments (not including errata content) or revisions do not apply to this section, however, encourage the present section Research on the parties to reach an agreement to use the latest versions of these documents. For undated references, the latest edition of In this section. GB/T 22274.2 good laboratory practice oversight Guide Part 2. Perform laboratory research and audit guidelines GB/T 22278 principles of Good Laboratory Practice3 Terms and DefinitionsGB/T 22278 in the terms and definitions apply to this section. 3.1 In order to verify whether the test body to follow the principles of GLP, and take its periodic inspection and (or) study audits. 3.2 Member States in order to monitor whether or not followed GLP testing facility within which to develop a special program, which through inspection and study audits square It is embodied. 3.3 Responsible for domestic testing facility GLP compliance oversight in member states to establish and to fulfill other GLP-related decisions may be provided by the State One or more departments given functions. 3.4 The test procedures and institutions operating conduct a site survey to assess the extent of the agency in line with the principles of GLP. During the inspection should be investigated Management structure and operating procedures of the testing facility and meet with key technical staff, but also to test the quality and integrity of the data issued by the agency will be Evaluation and reporting. 3.5 Record raw data and related stage or final reports for comparison to confirm. whether the original data in the report was accurate anti Ying; whether the test in accordance with the study plan and standard operating procedures (SOPs) were; process data generated affect the validity of the experiment; and ......Tips & Frequently Asked Questions:Question 1: How long will the true-PDF of GB/T 22274.1-2008_English be delivered?Answer: Upon your order, we will start to translate GB/T 22274.1-2008_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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