|
US$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
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| GB/T 22275.7-2008 | English | 174 |
Add to Cart
|
3 days [Need to translate]
|
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
| Valid |
GB/T 22275.7-2008
|
PDF similar to GB/T 22275.7-2008
Basic data | Standard 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
Foreword
GB/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 application
1 Scope
This 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 references
The 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 Practice
3 Terms and Definitions
GB/T 22278 in the terms and definitions apply to this section.
4 main technical specifications
4.1 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. Our tax invoice, downloaded/delivered in 9 seconds, includes all tax/VAT and complies with 100+ countries' tax regulations (tax exempted in 100+ countries) -- See Avoidance of Double Taxation Agreements (DTAs): List of DTAs signed between Singapore and 100+ countriesQuestion 4: Do you accept my currency other than USD?Answer: Yes. If you need your currency to be printed on the invoice, please write an email to [email protected]. In 2 working-hours, we will create a special link for you to pay in any currencies. Otherwise, follow the normal steps: Add to Cart -- Checkout -- Select your currency to pay.
|