GB/T 22274 "Guidelines for Good Laboratory Practice Supervision Departments" is divided into 3 parts. This part is Part 3 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. 9: "Guidelines for the Preparation of Good Laboratory Practice Inspection Reports" [OCDE/GD(95)114]. This part of GB/T 22274 specifies the requirements, other information and approval of inspection reports under good laboratory practices. This part is applicable to GLP supervision departments established in my country. This part has been edited as follows. -- The foreword and introduction in the original text have been deleted. GB/T 22274.3-2008 Guidelines for Good Laboratory Practice Supervision Departments Part 3: Guidelines for the Preparation of Good Laboratory Practice Inspection Reports GB/T22274.3-2008 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 3 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. 9: "Guidelines for the Preparation of Good Laboratory Practice Inspection Reports" [OCDE/GD(95)114]. This part of GB/T 22274 specifies the requirements, other information and approvals for inspection reports under good laboratory practice. This part is applicable to GLP supervision departments established in China. This part has been modified as follows. ——The foreword and introduction in the original text have been deleted.
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 3 parts:
--- Part 1: Guidance on Good Laboratory Practice Compliance Supervision 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 3 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. 9: "Guidelines for the Preparation of Good Laboratory Practice Inspection Reports" [OCDE/GD(95)114].
This part has been edited as follows.
--- The foreword and introduction in the original text have been deleted.
This part was proposed and coordinated by the National Technical Committee for Standardization of Hazardous Chemicals Management (SAC/TC251).
The drafting unit of this part: Shandong Entry-Exit Inspection and Quarantine Bureau.
The main drafters of this part: You Ruihua, Song Zhenqian, Huang Honghua, Wang Huiyong.
The clauses in the following documents become the clauses 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, the parties to an agreement 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 22278 Principles of Good Laboratory Practice

ICS 03. 120. 20
National Standard of the People's Republic of China
GB/T 22274.3—2008
Guidance for Good Laboratory Practice (GLP) monitoring authorities-Part 3 : Guidance for the preparation of GLP inspection reports Issued on August 4, 2008
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
Implementation on April 1, 2009
GB/T 22274.3—2008
Guidance for Good Laboratory Practice (GLP) monitoring authorities-Part 3 : Guidance for the preparation of GLP inspection reports Issued on August 4, 2008
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
Implementation on April 1, 2009
GB/T 22274.3—2008 GB/T22274.3—2008
This part is equivalent to the Organization for Economic Cooperation and Development (OECD) Good Laboratory Practice (GLP) principles and compliance supervision series document No. 9; "Guidelines for the Preparation of Good Laboratory Practice Inspection Reports" [QCDE/GD(95)111]. This part has been edited as follows. - The foreword and introduction in the original text have been deleted. This part was proposed and managed by the National Technical Committee for the Management of Hazardous Chemicals Standardization (SAC/TC251). The drafting unit of this part: Shandong Entry-Exit Inspection and Quarantine Bureau. The main drafters of this part: You Ruihua, Song Zhenqian, Huang Honghua, Wang Huishui. 1
1 Scope
Guidelines for Good Laboratory Practice Supervision Departments
Part 3: Guidelines for the Preparation of Good Laboratory Practice Inspection Reports
GB/T 22274.3—2008
This part of GB/T 22274 specifies the requirements, other information and approvals for inspection reports under good laboratory practice. This part applies to GLP supervision departments established in my country. 2 Normative references
The provisions in the following documents become 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 an agreement 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 22278
3 Terms and definitions
The terms and definitions in GB/T 22278 apply to this part. 4 Requirements
4.1 Title of report
4.1.1 There are many acceptable ways to organize an inspection report, but the key is to ensure that the report contains the necessary information and meets the requirements of the regulatory authorities. In general, the titles of the report include Abstract, Introduction, Narrative, Summary of Closing Discussion, and Appendix. The content under the heading of each section should accurately describe the test organization's compliance with the principles of GLP and the quality of any study report being audited. bzxz.net
4.1.2 The narrative title may include the following information: 4.1.2.1 Abstract
The abstract section of the report should appear first. It should provide background information on the test organization, the types of inspections performed, the deviations from the principles of GLP that were recorded, and the test organization's response to these deviations. Depending on national circumstances, the report may also include the inspector's determination of the laboratory's GLP compliance. 4.1.2.2 Introduction The introductory section should include some or all of the following information: a) Purpose and general description of the inspection, including the inspector's legal authority and the quality standards on which the inspection was based; b) Identification of the inspector and date of the inspection; description of the type of inspection (organizational inspection, study audit, etc.); c) Identification of the testing facility, including legal identity, mailing address and contact person (including telephone and fax); e) A description of the testing facility, including identification of the test substances and types of tests performed and information on facility layout and personnel; and e) Date of the previous GLP inspection, GLP compliance status after the inspection, and any relevant response made by the testing facility since the previous inspection.
4.1.2.3 Narrative Section
4.1.2.3.1 The narrative section of the report should contain a complete, factual description of the observations made and actions taken during the inspection. In general, the information recorded in this section should correspond to the following GLP principles: a) Organization and Personnel:
Quality Assurance Plan;
Facilities;
Apparatus, Materials, Reagents and Specimens,
Test Systems;
Test Specimens and Reference Materials:
Standard Operating Procedures;
Conduct of the Study,
Reporting of Study Results;
j) Storage and Retention of Records.
4.1.2.3.2 Deviations from GLP principles should be supported by documentation (e.g., photocopies, photographs or test specimens, etc.). All such documentation should be referenced and discussed in the narrative section and attached as an appendix. 4.1.2.3.3 When a study is selected for review, the inspection report should describe the procedures for conducting the review, including a description of the actual data or study that was reviewed. All findings should be discussed in the narrative section and documented in the appendix. 4.1.2.4 Closing Discussion
4.1.2.4.1 At the end of the inspection or study review, a closing meeting should be held between the inspection team and relevant management personnel at the testing site to discuss any deviations from the principles of GLP that were observed during the inspection or study review. During this meeting, if national policy permits, a written list should be submitted describing any deviations from the principles of GLP that were observed. The closing discussion should be summarized in this section.
4.1.2.4.2 The report should include the date and time of the closing meeting, the names of the attendees (inspection team, testing site, and others), and their contact information. A brief summary of the deviations from the principles of GLP noted by the inspection team during the site inspection and/or study review should also be provided. The test facility representative's response to the inspection team's comments should also be described. 4.1, 2.4.3 Once the observations are documented in a written report, the test facility shall acknowledge the findings of the inspector and commit to making corrections.
4.1.2.4.4 If a receipt for documents removed by the inspection team has been prepared and signed by the head of the facility, the person to whom the receipt was sent shall be identified. A copy of the receipt shall be included in the appendix. 4.1.2.5 Appendix
The appendix shall include copies of the documents mentioned in the report. The following documents may be included: a) Organization chart of the test facility;
b) Agenda for the inspection;
c) List of standard operating procedures to be verified during the inspection; d)
List of deviations observed;
e) Photocopies confirming the deviations observed. 4.2 Other information
In addition to the information described above, the report may also include other appropriate or required by the national conformity monitoring program title and information. For example, the inspection report may include the correction of deviations found in previous inspections, or the corrective measures taken during the current inspection. Others may include a cover page containing a brief description of the inspection. Some people also believe that the self-recording form 2
GB/T22274.3-2008
is more effective, especially when the inspection report is to classify, index and identify the information of a large and comprehensive organization. Some reports include a "Conclusion" section that communicates the classification of the inspected testing facility's GLP compliance status as determined during the inspection. Some or all of the above is acceptable. 4.3 Approval
The report shall be signed and dated by the inspection team leader and other inspectors in accordance with their respective responsibilities. GB/T 22274.3-2008
National Standard of the People's Republic of China
Guidelines for Good Laboratory Practice Supervision Authorities
Part 3: Guidelines for the Preparation of Good Laboratory Practice Inspection Reports
GB/T 22274.3—2008
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