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GB/T 22275.6-2008: Requirements of conduct for Good Laboratory Practice (GLP) -- Part 6: The application of the principles of GLP to computerised systems
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| GB/T 22275.6-2008 | English | 229 |
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Requirements of conduct for Good Laboratory Practice (GLP) -- Part 6: The application of the principles of GLP to computerised systems
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GB/T 22275.6-2008
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Basic data | Standard ID | GB/T 22275.6-2008 (GB/T22275.6-2008) | | Description (Translated English) | Requirements of conduct for Good Laboratory Practice (GLP) -- Part 6: The application of the principles of GLP to computerised systems | | Sector / Industry | National Standard (Recommended) | | Classification of Chinese Standard | A00 | | Classification of International Standard | 03.120.20 | | Word Count Estimation | 10,153 | | Date of Issue | 2008-08-04 | | Date of Implementation | 2009-04-01 | | Quoted Standard | GB/T 19001; GB/T 22278 | | Adopted Standard | OECD GLP, IDT; OCDEGD (95)115, 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 principles of GLP computerized system applications and management, including the responsibilities of various departments, relevant training, equipment and instrumentation requirements, computerized system maintenance and disaster recovery, data recording and processing, computerized the system's security, computerized system validation procedures, with regard to its development, validation, operation and maintenance of the documentation requirements. This section applies to GLP principles of computerized systems. | GB/T 22275.6-2008: Requirements of conduct for Good Laboratory Practice (GLP) -- Part 6: The application of the principles of GLP to computerised systems
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Requirements of conduct for Good Laboratory Practice (GLP) Part 6. The application of the principles of GLP to computerised systems
ICS 03.120.20
A00
National Standards of People's Republic of China
Implementation requirements of Good Laboratory Practice
Part 6. principles of Good Laboratory Practice
Application of computerized systems
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 Part of 622,275.
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. 10. "GLP principles computerized system application" [OCDE/GD (95) 115].
This part of the editorial changes as follows.
--- Remove the foreword and introduction of the original;
--- Remove the original definition Note 1.
Appendix A of this section is an informative annex.
This part of the National Chemicals Management Standardization Technical Committee dangerous (SAC/TC251) and focal points.
The drafting of this section. Shandong CIQ, the Dangerous Chemicals Management Standardization Technical Committee.
The main drafters of this section. courtesy car east, saffron yellow, Wangkuai Yong, Yu Wen Lin, Sun Zhongsong.
Implementation requirements of Good Laboratory Practice
Part 6. principles of Good Laboratory Practice
Application of computerized systems
1 Scope
This section GB/T 22275 specifies the application and management of GLP principles under the computerized system, including the responsibilities of various departments, phase
Requirements related to training, equipment and instruments, computerized system maintenance and disaster recovery, the recording and processing of data, computerized system
Safety, computerized system validation procedures, on their development, validation, operation and maintenance documentation requirements.
This section applies to applications under GLP principles computerized system.
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 19001 Quality Management System Requirements
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 Requirements
4.1 Scope
4.1.1 All parties used to generate computerized system measurement and evaluation of data submitted to the Governing Body shall be consistent with the principles of GLP
Formula development, validation, operation and maintenance.
4.1.2 in the plan, perform and report on the study may be for a variety of purposes using multiple systems computerized. These objects can be
It can include direct or indirect acquisition of data from automated instruments, operation and control of automation equipment and processing, reporting and storage number
according to. For these different activities, computerized systems are different, can be a programmable analytical instrument, it can be a
Computer connected to the laboratory information management system for multi-purpose personal computer. In the scope of any computer-related, GLP should in principle be
application.
Step 4.2
4.2.1 applied to a study submitted to the Governing Body for the purpose of implementation of the computerized system shall be properly designed, can be enough
And apply force to its intended purpose. It should have appropriate procedures to control and maintain these systems, which should follow the principles of GLP
Approach to the development, validation and operation.
4.2.2 Demonstration computerized system is suitable for its intended purpose is very important, which is called to confirm the computer.
4.2.3 confirmation process will ensure strict computerized system to achieve its design requirements. This shall take a formal confirmation of the plan and in making
Performed before use.
5 GLP Principle in computerized systems
The following considerations mentioned above, will be referred to the application of the principles of GLP in the computerized system to help.
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