GB/T 22274 "Guidelines for Good Laboratory Practice Supervision Departments" is divided into three parts. This part is the first part of GB/T 22274. This part is equivalent to the Organization for Economic Cooperation and Development (OECD) Good Laboratory Practice (GLP) Principles and Conformity Supervision Series Document No. 2: "Guidelines for Good Laboratory Practice Supervision Departments: Revised Guidelines for GLP Conformity Supervision Procedures" [OCDE/GD(95)66]. This part of GB/T 22274 specifies the administrative management, confidentiality, personnel and training of the supervision department in good laboratory practice, GLP compliance plan, follow-up work of test organization inspection and research audit, and appeal procedures. This part is applicable to GLP supervision departments established in my country. The following editorial changes have been made to this part: - (1) Foreword and Introduction in the original text have been deleted; (2) Part II: OECD Council Directives related to GLP principles and conformity supervision. GB/T 22274.1-2008 Guidance for Good Laboratory Practice Supervision Departments Part 1: Guidance for Good Laboratory Practice Compliance Supervision Procedures GB/T22274.1-2008 Standard download decompression password: www.bzxz.net
GB/T 22274 "Guidelines for Good Laboratory Practice Supervision Departments" is divided into 3 parts. This part is Part 1 of GB/T 22274. This part is equivalent to the Organization for Economic Cooperation and Development (OECD) Good Laboratory Practice (GLP) Principles and Compliance Supervision Series Document No. 2: "Guidelines for Good Laboratory Practice Supervision Departments: Revised Guidance for GLP Compliance Supervision Procedures" [OCDE/GD (95) 66]. This part of GB/T 22274 specifies the administrative management, confidentiality, personnel and training of the supervision department in good laboratory practice, GLP compliance plan, follow-up work of test organization inspection and research audit, and appeal procedures. This part applies to GLP supervision departments established in China. This part has been edited as follows: ——Deleted (1) Foreword and Introduction; (2) Part II: OECD Council Directives related to GLP principles and compliance monitoring.
class="f14" style="padding-top:10px; padding-left:12px; padding-bottom:10px;"> GB/T 22274 "Guidelines for Good Laboratory Practice Supervision Departments" is divided into three parts:
--- Part 1: Guidance on Good Laboratory Practice Compliance Monitoring Procedures;
--- Part 2: Guidance on the Implementation of Laboratory Inspections and Research Audits;
--- Part 3: Guidance on the Preparation of Good Laboratory Practice Inspection Reports.
This part is Part 1 of GB/T 22274.
This part is equivalent to the Organization for Economic Cooperation and Development (OECD) Good Laboratory Practice (GLP) principles and compliance monitoring series document No. 2: "Guidelines for Good Laboratory Practice Monitoring Authorities: Revised Guidelines for GLP Compliance Monitoring Procedures" [OCDE/GD(95)66].
This part has been edited as follows:
--- Deleted (1) Foreword and Introduction; (2) Part II: OECD Council Directives related to GLP principles and compliance monitoring.
This part was proposed and coordinated by the National Technical Committee for Standardization of Dangerous Chemicals Management (SAC/TC251).
The drafting unit of this part: Shandong Entry-Exit Inspection and Quarantine Bureau.
The main drafters of this part: Song Zhenqian, Liu Xuehui, Wang Xiaobing, Yu Xiao.
The provisions in the following documents become the provisions of this part through reference in this part of GB/T 22274. For dated references, all subsequent amendments (excluding errata) or revisions are not applicable to this part. However, parties to agreements based on this part are encouraged to investigate whether the latest versions of these documents can be used. For undated references, the latest versions apply to this part.
GB/T22274.2 Guidelines for Supervision Departments on Good Laboratory Practice Part 2: Guidelines for Performing Laboratory Inspections and Research Audits
GB/T22278 Principles of Good Laboratory Practice

ICS 03,120.20
National Standard of the People's Republic of China
GB/T 22274.1—2008
Guidance for Good Laboratory Practice (GLP) monitoring authorities-Part 1 Guides for compliance monitoring procedures for GLP2008-08-04Promulgated
General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of ChinaStandardization Administration of China
2009-04-01Implementation
GB/T 22274Guidance for Good Laboratory Practice (GLP) monitoring authorities-Part 1 Guides for compliance monitoring procedures for GLP is divided into 3 parts: - Part 1: Guidelines for compliance monitoring procedures for GLP; - Part 2: Guidelines for performing laboratory inspections and research audits1 - Part 3: Guidelines for the preparation of GLP inspection reports. This part is Part 1 of GB/T 22274. GB/T 22274.1—2008
This part is equivalent to the Organization for Economic Cooperation and Development (OECD) Good Laboratory Practice (GLP) principles and compliance monitoring series document No. 2: Guidance for Good Laboratory Practice Supervision Departments: Revised Guide to GLP Compliance Monitoring Procedures [OCDE/GD(95)66]. This part has been revised as follows: (1) Foreword and Introduction in the original text have been deleted; (2) Part II: OECD Council Directives related to GLP principles and compliance monitoring.
This part was proposed and coordinated by the National Technical Committee for Standardization of Dangerous Chemicals Management (SAC/TC251). The drafting unit of this part: Shandong Exit-Entry Inspection and Quarantine Bureau. The main drafters of this part: Song Zhenqian, Liu Xuehui, Wang Xiaobing, Yu Xiao. I
1 Scope
Guidelines for Good Laboratory Practice Supervision Departments
Part 1: Good Laboratory Practice
Guidelines for Conformity Supervision Procedures
GB/T 22274. 1-—2008
This part of GB/T 22274 specifies the administration, confidentiality, personnel and training of supervision departments in good laboratory practice, GLP compliance plans, follow-up work of test organization inspections and research audits, and appeal procedures. This part applies to GLP supervision departments established in my country. 2 Normative references
The provisions of the following documents become the provisions of this part through reference in this part of GB/T 22274. For any dated referenced document, all subsequent amendments (excluding errata) or revisions are not applicable to this part. However, parties to agreements based on this part are encouraged to study whether the latest versions of these documents can be used. For any undated referenced document, the latest version applies to this part.
GB/T 22274.2 Guidelines for Good Laboratory Practice Monitoring Authorities Part 2: Guidelines for the Performance of Laboratory Inspections and Research Audits GB/T 22278 Principles of Good Laboratory Practice
3 Terms and Definitions
Terms and definitions in GB/T 22278 apply to this part. 3.1
GLP compliance monitoring GLP compliance monitoring Periodic inspections and/or research audits of test institutions to verify whether they comply with GLP principles. 3.2
GLP compliance program GLP compliance programme A special program established by a member state to monitor whether domestic test institutions comply with GLP, which is implemented through inspections and research audits.
GLP monitoring authority GLP monitoring authority One or more departments established in a member state that are responsible for GLP compliance monitoring of domestic test institutions and perform other GLP-related functions that may be determined by the state.
test facility inspectior
Test facility inspection
An on-site investigation of a test facility's procedures and operations to assess the facility's compliance with GLP principles. During the inspection, the test facility's management structure and operating procedures should be investigated and key technical personnel should be interviewed. The quality and integrity of the data produced by the test facility should also be evaluated and reported.
Study auditstudyaudit
Compare raw data with relevant records in interim or final reports to confirm: whether the raw data are accurately reflected in the report; whether the experiment was conducted in accordance with the study plan and standard operating procedures (SOPs); whether the process of data generation affects the validity of the experiment, and obtain information outside the report.
Inspector
A person who conducts test facility inspections and study audits on behalf of the GLP oversight department. 3.7
GLP compliance statusGLP compliancestatusThe level of compliance of the testing organization with the GLP principles as assessed by the GLP supervision department. 3.8
Regulatory departmentregulatoryanthority
National agency that manages chemicals in accordance with the law. 4 Composition of the GLP compliance supervision program
4.1 Management
4.1.1 The CLP compliance program should be the responsibility of an appropriately constituted, legally confirmed, and adequately staffed organization. The organization works within a clear management framework.
4.1.2 Member States should:
a) ensure that the GLP monitoring authority has direct or ultimate responsibility for the formation of a team of inspectors that includes the necessary technical and/or scientific expertise;
b) publish relevant documents on how GLP is implemented in its territory;
publish a document containing details of the GLP compliance program, including information on the legal and regulatory framework within which the monitoring program is implemented, as well as references to published legislation, standardized documents (e.g. regulations, implementing rules), inspection manuals, guidance notes, inspection intervals and/or inspection schedules;
d) maintain records of national and international testing facility inspections (including GLP compliance status) and study audits. 4.2 Confidentiality
4.2.1 GLP monitoring authorities may have access to certain information of commercial value and may in some cases need to remove commercially sensitive documents from testing facilities or quote them in detail in their reports. 4.2.2 Member States should: a) establish confidentiality rules that apply not only to inspectors but also to any person who has access to confidential information as a result of GLP compliance monitoring activities; and ensure that reports of testing facility inspections and study audits are only accessible to management, (where appropriate) the testing facility being inspected or in connection with the study audit, and/or the study sponsor; except for reports from which commercially sensitive information or confidential information has been removed. 4.3 Personnel and training 4.3.1 GLP monitoring authorities should: a) ensure that there are a sufficient number of inspectors; the number of inspectors required will depend on: the number of testing facilities covered by the GLP compliance program; the frequency of assessments of the testing facility's GLP compliance status; the number and complexity of studies undertaken by the testing facility; and the number of specific inspections or audits required by management. b) ensure that inspectors are adequately qualified and adequately trained; inspectors should have qualifications and practical experience in the disciplines relevant to chemical testing. The GLP monitoring authority should: - ensure that appropriate training is arranged for GLP inspectors based on their individual qualifications and experience; encourage exchanges with personnel from GLP monitoring authorities in other Member States and, if necessary, organize joint training activities to promote international coordination of the interpretation, application and monitoring of compliance with GLP principles. GB/T 22274.1—2008
c) ensure that inspectors (including hired experts) have no financial or other interests in the inspected test site, the audited study or the institution that initiated the study.
d) provide inspectors with appropriate identification (such as identification cards). 4.3.2 Inspectors may be:
a) regular staff of the GLP monitoring authority;
b) regular staff of a branch of the GLP monitoring authority; or c) contract employees or other personnel employed by the GLP monitoring authority to perform test site inspections or study audits. In the latter two cases, the GLP monitoring authority should determine the GI of the test site.The GLP compliance status and the quality and/or acceptability of the study audit, as well as any actions taken (if necessary) based on the results of the test site inspection or study audit, shall be ultimately responsible. 4.4 GLP Compliance Plan
The purpose of GLP compliance monitoring is to determine whether the test site follows the GLP principles in the implementation of the study and whether the resulting data are of sufficient quality. According to Article 4.1.2c), Member States shall publish details of their GLP compliance plan. This information shall include;
a) Definition of the scope and extent of the GLP compliance plan; A GLP compliance plan may cover only a limited number of chemicals, such as industrial chemicals, pesticides, pharmaceuticals, etc., or it may include all chemicals. The scope of GLP compliance should be defined in terms of the types of chemicals being inspected and the types of tests involving these chemicals (such as physical, chemical, toxicological and/or ecotoxicological tests, etc.). Provide guidance to the testing site on incorporating the GLP compliance program: b)
For health and environmental safety data obtained for registration purposes, the GLP principles may be mandatory. There should be a mechanism for the appropriate GLP oversight department to monitor the testing site's compliance with the GLP principles. Provide information on the types of testing site inspections and/or study audits: c
The GLP compliance program should include:
Provisions for testing site inspections, which include a routine testing site inspection and a review of one or more ongoing or completed research projects;
Provisions for specific testing site inspections and/or specific study audits required by regulatory authorities. For example, inspections and/or audits conducted in response to regulatory questions after data submission. d) Clearly define the rights of inspectors to enter the testing site and obtain testing site data (including samples, standard operating procedures, other documents, etc.); generally, inspectors will not enter the testing site against the wishes of the facility's management, but there may be situations where entry and use of data are necessary to protect public health or the environment. In such cases the GLP monitoring authority should be provided with such authority. e) Description of procedures for inspections of test facilities and study audits to verify compliance with GLP: The documentation should include procedures for inspecting the operation of the organization and for inspecting the conditions under which research projects are planned, conducted, monitored, and recorded. Guidance on these procedures is given in ISO 14001-2. f) Description of actions that may be taken following inspections of test facilities and study audits. 4.5 Follow-up to inspections of test facilities and study audits 4.5.1 When an inspection of a test facility or study audit is completed, the inspector shall prepare a written report on the findings of his inspection and/or audit. 4.5.2 Member States should take action during or after an inspection of a test facility or study audit in response to deviations from the principles of GLP. These appropriate actions should be described in the documentation of the GLP monitoring authority. 4.5.3 If only minor deviations from the principles of GLP are found during an inspection of a test facility or study audit, the facility should be required to correct these deviations. At an appropriate time, the inspector should return to the facility to confirm that it has taken corrective action. 4.5.4 When no or only minor deviations are found, the GLP monitoring department may: a) issue a statement that the test facility has been inspected and complies with the GLP principles. The statement should also include the date of the inspection and the types of tests conducted at the test facility at that time (if applicable). These statements can be used to provide information to the GLP monitoring departments of other Member States; and/or
1) provide a detailed report on the results of the study audit to the management department that requested the audit. 4.5.5 When serious deviations from the GLP principles are found, the GLP monitoring department should take measures based on the special circumstances of each case and national laws or regulations on GLP compliance monitoring. The following actions may be taken, but are not limited to: a) issuing a statement detailing the deficiencies or errors found that may affect the validity of the studies conducted at the facility; b) issuing a recommendation to management that the studies be rejected; c) suspending inspections and study reviews of the facility, for example, removing the facility from the GLP compliance program or any existing list of GLP inspections, when administratively feasible; d) requiring a statement detailing the deviation to be included in the report of a particular study; c) taking action through the courts if the circumstances, legal and/or administrative procedures warrant. 4.6 Appeals Procedures
Questions or differences of opinion between inspectors and facility management will normally be resolved during the facility inspection or study review process. However, the parties may not always reach agreement, so a procedure should exist for the facility to present its views on the results of the inspection or study review and/or the next steps that the GLP oversight authority intends to take. All rights reserved. All rights reserved. All rights reserved.
Book number: 155066·1-34008
GB/T 22274. 1-2008
Price:
People's Republic of China
National Standard
Guidelines for Good Laboratory Practice Supervision Departments
Part 1: Good Laboratory Practice
Guidelines for Conformity Supervision Procedures
GB/T 22274,1—2008
Published and distributed by China Standard Promotion Publishing House
No. 16, Sanlihebei Street, Fuxingmenwai, Beijing
Postal Code: 100045
Website: www, spc, nct, cnbzxz.net
Tel: 58523946
68517548
Printed by Anhuangdao Printing Factory of China Standard Press and distributed by Xinhua Bookstores in various places
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Report telephone: (010) 685335335 Follow-up of test facility inspections and study audits 4.5.1 When a test facility inspection or study audit is completed, the inspector shall prepare a written report of the findings of the inspection and/or audit. 4.5.2 Member States shall take action during or after a test facility inspection or study audit in response to deviations from the principles of GLP. These appropriate actions shall be described in the GLP monitoring authority's documentation. 4.5.3 If only minor deviations from the principles of GLP are found during a test facility inspection or study audit, the facility shall be required to correct these deviations. At an appropriate time, the inspector shall return to the facility to confirm that it has taken corrective action. 4.5.4 When no or only minor deviations are found, the GLP monitoring authority may: a) Issue a statement that the test facility has been inspected and is in compliance with the principles of GLP. The statement shall also include the date of the inspection and, where applicable, the types of tests being conducted at the test facility at that time. These statements can be used to provide information to the GLP monitoring departments of other Member States; and/or 1) provide a detailed report on the results of the study audit to the management department that requested the audit. 4.5.5 When serious deviations from the GLP principles are found, the GLP monitoring department should take measures based on the special circumstances of each case and the national laws or management regulations for GLP compliance monitoring. The following actions may be taken, but are not limited to: a) issuing a statement detailing the deficiencies or errors found that may affect the validity of the studies conducted at the facility; b) issuing a recommendation to management that the studies be rejected; c) suspending inspections and study reviews of the facility, for example, removing the facility from the GLP compliance program or any existing list of GLP inspections, when administratively feasible; d) requiring a statement detailing the deviation to be included in the report of a particular study; c) taking action through the courts if the circumstances, legal and/or administrative procedures warrant. 4.6 Appeals Procedures
Questions or differences of opinion between inspectors and facility management will normally be resolved during the facility inspection or study review process. However, the parties may not always reach agreement, so a procedure should exist for the facility to present its views on the results of the inspection or study review and/or the next steps that the GLP oversight authority intends to take. All rights reserved. All rights reserved. All rights reserved.
Book number: 155066·1-34008
GB/T 22274. 1-2008
Price:
People's Republic of China
National Standard
Guidelines for Good Laboratory Practice Supervision Departments
Part 1: Good Laboratory Practice
Guidelines for Conformity Supervision Procedures
GB/T 22274,1—2008
Published and distributed by China Standard Promotion Publishing House
No. 16, Sanlihebei Street, Fuxingmenwai, Beijing
Postal Code: 100045
Website: www, spc, nct, cn
Tel: 58523946
68517548
Printed by Anhuangdao Printing Factory of China Standard Press and distributed by Xinhua Bookstores in various places
Format: 880×12301/16
Printing sheet: 0.5 Words: 8
First edition: October 2008 First printing: October 2008*
Book number: 155066-1-34008
8Price: 10.00 yuan
If there is any printing error, our distribution center will replace it. Copyright infringement will be investigated
Report telephone: (010) 685335335 Follow-up of test facility inspections and study audits 4.5.1 When a test facility inspection or study audit is completed, the inspector shall prepare a written report of the findings of the inspection and/or audit. 4.5.2 Member States shall take action during or after a test facility inspection or study audit in response to deviations from the principles of GLP. These appropriate actions shall be described in the GLP monitoring authority's documentation. 4.5.3 If only minor deviations from the principles of GLP are found during a test facility inspection or study audit, the facility shall be required to correct these deviations. At an appropriate time, the inspector shall return to the facility to confirm that it has taken corrective action. 4.5.4 When no or only minor deviations are found, the GLP monitoring authority may: a) Issue a statement that the test facility has been inspected and is in compliance with the principles of GLP. The statement shall also include the date of the inspection and, where applicable, the types of tests being conducted at the test facility at that time. These statements can be used to provide information to the GLP monitoring departments of other Member States; and/or 1) provide a detailed report on the results of the study audit to the management department that requested the audit. 4.5.5 When serious deviations from the GLP principles are found, the GLP monitoring department should take measures based on the special circumstances of each case and the national laws or management regulations for GLP compliance monitoring. The following actions may be taken, but are not limited to: a) issuing a statement detailing the deficiencies or errors found that may affect the validity of the studies conducted at the facility; b) issuing a recommendation to management that the studies be rejected; c) suspending inspections and study reviews of the facility, for example, removing the facility from the GLP compliance program or any existing list of GLP inspections, when administratively feasible; d) requiring a statement detailing the deviation to be included in the report of a particular study; c) taking action through the courts if the circumstances, legal and/or administrative procedures warrant. 4.6 Appeals Procedures
Questions or differences of opinion between inspectors and facility management will normally be resolved during the facility inspection or study review process. However, the parties may not always reach agreement, so a procedure should exist for the facility to present its views on the results of the inspection or study review and/or the next steps that the GLP oversight authority intends to take. All rights reserved. All rights reserved. All rights reserved.
Book number: 155066·1-34008
GB/T 22274. 1-2008
Price:
People's Republic of China
National Standard
Guidelines for Good Laboratory Practice Supervision Departments
Part 1: Good Laboratory Practice
Guidelines for Conformity Supervision Procedures
GB/T 22274,1—2008
Published and distributed by China Standard Promotion Publishing House
No. 16, Sanlihebei Street, Fuxingmenwai, Beijing
Postal Code: 100045
Website: www, spc, nct, cn
Tel: 58523946
68517548
Printed by Anhuangdao Printing Factory of China Standard Press and distributed by Xinhua Bookstores in various places
Format: 880×12301/16
Printing sheet: 0.5 Words: 8
First edition: October 2008 First printing: October 2008*
Book number: 155066-1-34008
8Price: 10.00 yuan
If there is any printing error, our distribution center will replace it. Copyright infringement will be investigated
Report telephone: (010) 68533533
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