GB/T 22275.7-2008 English PDFUS$174.00 ยท In stock
Delivery: <= 3 days. True-PDF full-copy in English will be manually translated and delivered via email. GB/T 22275.7-2008: Requirements of conduct for Good Laboratory Practice (GLP) -- Part 7: The application of the GLP principles to the organisation and management of multi-site studies Status: Valid
Basic dataStandard ID: GB/T 22275.7-2008 (GB/T22275.7-2008)Description (Translated English): Requirements of conduct for Good Laboratory Practice (GLP) -- Part 7: The application of the GLP principles to the organisation and management of multi-site studies Sector / Industry: National Standard (Recommended) Classification of Chinese Standard: A00 Classification of International Standard: 03.120.20 Word Count Estimation: 9,979 Date of Issue: 2008-08-04 Date of Implementation: 2009-04-01 Quoted Standard: GB/T 22275.4; GB/T 22278 Adopted Standard: ENVJMMONO (2002)9, 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 multi-site study of management and control, quality assurance, master schedules, research projects, the implementation of the study, the findings of the report, standard operating procedures, records and materials storage and safekeeping. In addition to national legislation explicitly exempted under this Part of the principle of good laboratory practice regulations required for all non- clinical health and environmental safety studies, including pharmaceuticals, pesticides, food additives and feed additives, cosmetics, veterinary drugs and similar product registration or application for a permit, as well as industrial chemicals management. GB/T 22275.7-2008: Requirements of conduct for Good Laboratory Practice (GLP) -- Part 7: The application of the GLP principles to the organisation and management of multi-site studies---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. Requirements of conduct for Good Laboratory Practice (GLP) Part 7. The application of the GLP principles to the organisation and management of multi-site studies ICS 03.120.20 A00 National Standards of People's Republic of China Good Laboratory Practice implementation requirements - Part 7. Good Laboratory Practice principles of multi-site research organization And management application 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 22275 "to implement the requirements of Good Laboratory Practice" is divided into seven sections. --- Part 1. Quality Assurance and Good Laboratory Practice; --- Part 2. Good Laboratory Practice Research project leader roles and responsibilities; --- Part 3. Laboratory Supplier of Good Laboratory Practice Principles compliance; --- Part 4. Good Laboratory Practice principles in the field of applied research; --- Part 5. Application of the principles of Good Laboratory Practice in short term studies; --- Part 6. Application of the principles of Good Laboratory Practice in the computerized system; --- Part 7. application of the principles of good laboratory practice in the organization and management of multi-site studies. This section GB/T 22275 Part 7. 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. 13. "GLP principles in the organization and management of multi-site study in the application" [ENV/JM/MONO (2002) 9]. This section includes the following editorial changes. --- Delete information about the OECD, the introduction, preface about the content of the sessions held and directory section. 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. Wan Min, courtesy car east Wangkuai Yong, Wang Tong territory, Wang Xiaobing. Good Laboratory Practice implementation requirements - Part 7. Good Laboratory Practice principles of multi-site research organization And management application1 ScopeThis section GB/T 22275 specifies the multi-site study of management and control, quality assurance, real master schedule, research programs, research Shi, the findings of the report, standard operating procedures, records and materials storage and safekeeping. Except as expressly exempted national legislation, good laboratory provided for in this part of the normative principles (hereinafter referred to as GLP principles) applicable laws and regulations All non-clinical health and environmental safety studies required, including pharmaceuticals, pesticides, food additives and feed additives, cosmetics, veterinary drugs And similar products registration or application for a permit, as well as industrial chemicals management.2 Normative referencesThe following documents contain provisions which, through reference GB/T 22275 in this section constitute provisions of this section. For dated reference documents Member, all subsequent amendments (not including errata content) or revisions do not apply to this section, however, encouraged to reach under this section Parties to research agreement to use the latest versions of these documents. For undated reference documents, the latest versions apply to this section. GB/T 22275.4 good laboratory practice - Part 4. Good Laboratory Practice principles in the field of applied research GB/T 22278 principles of Good Laboratory Practice3 Terms and DefinitionsGB/T 22278 in the terms and definitions apply to this section.4 main technical specifications4.1 multi-site study 4.1.1 Multi-site studies, implementation, monitoring, recording, reporting and archiving of a series of potential problems that should be explained To ensure that the principles of GLP affected. Plan different research activities in different places means that the implementation of research, communication, control is very important. 4.1.2 Although more than one workplace study will constitute the work performed in multiple locations (including the testing facility and all test sites). but Multi-site study is a single study should be performed in accordance with the principles of GLP. This means that the program should be the only, the only project leader and sole The final report. In the initial study plan, participating sites and managers should be aware that they work only part Part of the research project leader control and should not be used as a separate study to implement. 4.1.3 various places of work carried out by the need to clearly explain the initial stage plan. So that the relevant parties can participate in the research Study plan before finalizing an agreement on control measures. It can clear distribution of responsibilities and effective communication to avoid the implementation of a multi-site study executed between the parties involved 4.1.4 Research on multiple issues. Participants include the Principal, Principal, managers, project representatives, quality assurance and research various places personnel. 4.1.5 All relevant parties should be aware. When a multi-site study execution in many countries, may be due to the national culture, language and Differences GLP compliance program oversight caused some additional problems. In this case, it may be necessary to break the country's GLP ......Tips & Frequently Asked Questions:Question 1: How long will the true-PDF of GB/T 22275.7-2008_English be delivered?Answer: Upon your order, we will start to translate GB/T 22275.7-2008_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 22275.7-2008_English with my colleagues?Answer: Yes. The purchased PDF of GB/T 22275.7-2008_English will be deemed to be sold to your employer/organization who actually pays for it, including your colleagues and your employer's intranet.Question 3: Does the price include tax/VAT?Answer: Yes. 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