This standard is equivalent to the Organization for Economic Cooperation and Development (OECD) Good Laboratory Practice (GLP) principles and compliance monitoring series document No. 11: "The tasks and responsibilities of the client in the application of GLP principles" [ENV/MC/CHEM (98) 16]. This standard applies to the requirements for the tasks and responsibilities of the client in tests and studies conducted in accordance with the principles of Good Laboratory Practice (GLP). When entrusting a non-clinical health and environmental safety study, the client should ensure that the test organization can conduct the study in accordance with the requirements of the GLP principles and provide relevant chemical safety information and property identification data. This standard has been edited as follows: - The foreword of the original text has been deleted. GB/T 22277-2008 Good Laboratory Practice Recommended Document Tasks and Responsibilities of the Client in the Application of Good Laboratory Practice Principles GB/T22277-2008 Standard Download Decompression Password: www.bzxz.net
This standard is equivalent to the Organization for Economic Cooperation and Development (OECD) Good Laboratory Practice (GLP) Principles and Conformity Monitoring Series Document No. 11: "Tasks and Responsibilities of the Client in the Application of GLP Principles" [ENV/MC/CHEM(98)16]. This standard applies to the requirements for the tasks and responsibilities of the client in tests and studies conducted in accordance with the principles of Good Laboratory Practice (GLP). When entrusting a non-clinical health and environmental safety study, the client should ensure that the test organization can conduct the study in accordance with the requirements of the GLP principles and provide relevant chemical safety information and property identification data. This standard has been edited as follows: ——The foreword of the original text has been deleted.
class="f14" style="padding-top:10px; padding-left:12px; padding-bottom:10px;"> This standard is equivalent to the Organization for Economic Cooperation and Development (OECD) Good Laboratory Practice (GLP) principles and compliance monitoring series document No.11: "Tasks and Responsibilities of the Client in the Application of GLP Principles" [ENV/MC/CHEM(98)16].
This standard has been edited as follows:
--- The foreword of the original text has been deleted.
This standard was proposed and coordinated by the National Technical Committee for the Administration of Hazardous Chemicals (SAC/TC251).
The drafting unit of this standard: Shandong Entry-Exit Inspection and Quarantine Bureau.
The main drafters of this standard: Huang Honghua, Tao Qiang, Wang Xiaobing, Yu Xiao, Yue Zhiqin, Yu Wenlian.
The clauses in the following documents become the clauses of this standard through reference in this standard. For all dated references, all subsequent amendments (excluding errata) or revisions are not applicable to this standard. However, parties to agreements based on this standard are encouraged to study whether the latest versions of these documents can be used. For all undated references, the latest versions are applicable to this standard.
GB/T22278-2008 Principles of Good Laboratory Practice

ICS 03. 120. 20
National Standard of the People's Republic of China
GB/T 22277-2008
Advisory document for good laboratory practice-The role and responsibilities of the sponsor in the application ofthe principles of GLP
Published on August 4, 2008
Anti-counterfeiting by coding
General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China Administration of Standardization of the People's Republic of China
Implemented on April 1, 2009
GB/T 222772008
This standard is equivalent to the Organization for Economic Cooperation and Development (OECD) Good Laboratory Practice (GLP) principles and compliance monitoring series document No. 11: "The role and qualifications of the client in the application of GLP principles" [ENV/MC/CHEM (98) 16]. This standard has been edited as follows: The foreword of the original text has been removed.
This standard was proposed and managed by the National Technical Committee for the Administration of Hazardous Chemicals (SAC/TC251). The drafting unit of this standard: Shandong Entry-Exit Inspection and Quarantine Bureau. The main drafters of this standard: Huang Honghua, Tao Qiang, Wang Xiaobing, Yu Xiao, Yue Zhiqin, Yu Wenlian 1
1 Scope
Good Laboratory Practice Recommended Documents
Tasks and Responsibilities of the Client in the Application of Good Laboratory Practice Principles
GB/T 22277--2008
This standard applies to the requirements for the tasks and responsibilities of the client in tests and studies conducted in accordance with the principles of Good Laboratory Practice (GLP). When entrusting a non-clinical health and environmental safety study, the client should ensure that the test organization can conduct the study in accordance with the requirements of the GLP principles and provide relevant chemical safety information and characteristic identification data. 2 Normative References
The clauses in the following documents become the clauses of this standard through reference in this standard. For all referenced documents with a notified date, all subsequent amendments (excluding errata) or revisions are not applicable to this standard. However, parties to an agreement based on this standard are encouraged to study whether the latest versions of these documents can be used. For any undated referenced document, the latest edition applies to this standard. GB/T 22278-2008 Principles of Good Laboratory Practice 3 Terms and Definitions
The terms and definitions in GB/T 22278-2008 apply to this standard. 4 Requirements
4.1 Explanation
Although GB/T 22278--2008 only specifies some of the responsibilities of the client in the study, there are still some undefined responsibilities of the client. This is because the client is often the person who initiates one or more studies and directly submits the results to the regulatory department. The client should play an active role in confirming that all nonclinical health and environmental safety studies comply with the principles of GLP. The client cannot simply rely on the guarantee of the contracted testing agency to organize or implement these studies. The following guidance describes the defined and undefined responsibilities that the client should perform.
4.2 Definitions
Client means an entity that commissions, supports and/or submits a nonclinical health, environmental and safety study (see 2.2.5 of GB/T 22278-2008).
Note 1: Clients may include:
An entity that initiates a nonclinical health and environmental safety study and provides support through financial or other resources. An entity that submits a nonclinical health and environmental safety study to a regulatory agency to support product registration or other applications that require compliance with GLP principles.
Note 2: "Entity\ may include an individual, partnership, enterprise, association, scientific or academic institution, government department, or organizational unit thereof, or other legally identifiable group.
4.3 Responsibilities of the Client
The client should understand the requirements of the GLP principles, especially those related to the positions of the test institution manager and the project leader/project representative.
Note that if part of the study is subcontracted by the client to a factory subcontractor, the client should understand that the responsibility for the entire study is still borne by the project sponsor, including the validity of the original data and reports.
4.4 When entrusting a non-clinical health and environmental safety study, the client should ensure that the test institution can follow the requirements of the GLP principles.
GB/T 22277—2008
To assess the ability of a laboratory to conduct a study in accordance with the principles of GLP. NOTE 1 There are a number of ways to assess the ability of a laboratory to conduct a study in accordance with the principles of GLP. It can help the sponsor to monitor the contracted laboratory before the start of the study and during the study to ensure that the laboratory's facilities, equipment, standard operating procedures and personnel comply with GLP requirements, depending on its nature, time required and complexity. If the laboratory is included in a national CLP compliance monitoring program, it is also possible to contact the national GLP monitoring department to confirm the laboratory's current GLP compliance status. NOTE 2: The sponsor should be aware that, notwithstanding any confidentiality agreement, the national GLP monitoring department has access to all data generated by the GLP compliance organization.
4.5 When several studies are combined into one When the individual packages are submitted to the management department, the client is responsible for the integrity of the package that is the unchanged final report. The client should ensure that there is an appropriate connection between his agent and all personnel conducting the study, such as the project leader, the quality assurance unit and the test agency management department. 4.6 Requirements for the client explicitly mentioned in GB/T22278-2008: 4.6.1 Nature of the test samples: "When the test samples are provided by the client, a cooperative mechanism should be established between the client and the test agency to verify the properties of the test samples used for the study. \ (See 3.6.2.3 in GB/T22278-2008). Note: The purpose of this requirement is to ensure that there is no confusion of test samples. 4.6.2 Research plan: "If the laws and regulations of the country where the study is carried out require it, the research plan should also be approved by the test agency management and the client. \(See 3.8.11 of GB/T22278-2008. Note: If the laws and regulations of some member states require it, the research plan should be approved by the management of the test institution and the client for legal considerations regarding the validity of the test data.
4.6.3 Contents of the research plan · "The research plan should include information about the client and the test institution, the name and address of the client" (see 3.8.2 of GB/T22278-2008), "The research plan should include if the laws and regulations of the country where the research is located require it, it should also include the test The date on which the test agency manager and the client sign and approve the research plan. \(See 3.8.2 in GB/T22278-2008). 4.6.4 Contents of the final report "The final report shall include... information related to the client and the test agency... the name and address of the client\(See 3.9.2 in GB/T22278-2008). 4.6.5 Preservation of records and materials: "If a test agency or contracted archive agency is about to close down and there is no legal successor, the archives shall be transferred to the archives of the research client. \(See GB /T22278-2008 3.10.5). Note: In this case, the client is required to establish an archive according to the GLP principles to properly store and access the research plan, original data, specimens, test samples, control substances and final reports. 4.7 Provision of chemical safety information
The client should inform the test institution of any known potential risks to human health or the environment in the test sample, as well as the protective measures that the test institution personnel should take. bzxz.net
4.8 Characterization of test samples
GB/T22278-2008 includes some requirements for the description of test sample characteristics [such as 3.6.2.1, 3.9.2.1d)]. These requirements include careful identification of test samples and description of their characteristics. Characterization should be completed by the contracted test agency or the client. If this characteristic identification is indeed completed by the client, this should be clearly mentioned in the final report. The client should understand that if the identification is not carried out in accordance with GLP principles, it may lead to the research project being rejected by the management departments of some member states. 4.9 If the client does not disclose the characterization data to the contracted testing agency, this fact should also be clearly mentioned in the final report. 4.10 Submission of data to regulatory authorities The ultimate responsibility for the scientific validity of a study lies with the project leader and not with the client. The client's responsibility is to make a conclusion based on the results of the study and whether to submit a chemical to the regulatory authorities for registration. 2 GB/T 22277-2008 National Standard of the People's Republic of China Good Laboratory Practice Constructive Document Tasks and Responsibilities of the Client in the Application of Good Laboratory Practice Principles GB/T 22277—2008 Published by China Standards Press No. 16, Sanlihebei Street, Fuxingmenwai, Beijing Postal Code: 100045 Website: spe.net. cn
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