GB/T 22275 "Requirements for the Implementation of Good Laboratory Practice" is divided into 7 parts. This part is the first part of GB/T 22275. This part of GB/T 22275 specifies the specific content and requirements of quality assurance activities under the GLP principles, including the responsibilities of quality assurance personnel, the relationship between quality assurance personnel and managers, the qualifications of quality assurance personnel and the situation of participating in the formulation process of standard operating procedures and research plans, quality assurance inspections, plans for quality assurance activities and demonstration of quality assurance activities and methods, reports on quality assurance inspections, review of data and final reports, quality assurance statements, quality assurance and quality assurance in non-regulatory studies and small test institutions. This part applies to quality assurance activities under the GLP principles. This part has made the following editorial changes: - The foreword of the original text has been deleted; - The background part in the original text has been deleted. GB/T 22275.1-2008 Requirements for the Implementation of Good Laboratory Practice Part 1: Quality Assurance and Good Laboratory Practice GB/T22275.1-2008 Standard Download Decompression Password: www.bzxz.net
GB/T 22275 "Requirements for the Implementation of Good Laboratory Practice" is divided into 7 parts, this part is the first part of GB/T 22275. This part of GB/T 22275 specifies the specific content and requirements of quality assurance activities under the GLP principles, including the responsibilities of quality assurance personnel, the relationship between quality assurance personnel and management, the qualifications of quality assurance personnel and the situation of participating in the formulation process of standard operating procedures and research plans, quality assurance inspections, plans for quality assurance activities and demonstration of quality assurance activities and methods, reports on quality assurance inspections, review of data and final reports, quality assurance statements, quality assurance and quality assurance in non-regulated studies and small test institutions. This part applies to quality assurance activities under the GLP principles. This part has been edited as follows: ——Deleted the foreword of the original text; ——Deleted the background part of the original text.
class="f14" style="padding-top:10px; padding-left:12px; padding-bottom:10px;"> GB/T 22275 "Requirements for the Implementation of Good Laboratory Practice" is divided into 7 parts, and this part is the first part of GB/T 22275.
This part has been edited as follows:
——Deleted the foreword of the original text;
——Deleted the background part of the original text.
The clauses in the following documents become the clauses of this standard through reference in this part of GB/T 22275. For all dated referenced documents, 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 any undated referenced document, the latest version shall apply to this standard.
GB/T 22274.1 Guidelines for Good Laboratory Practice Supervision Departments Part 1: Guidelines for Good Laboratory Practice Compliance Supervision Procedures
GB/T 22278-2008 Principles of Good Laboratory Practice

ICS 03.120.20
National Standard of the People's Republic of China
GB/T 22275.1—2008
Requirements of conduct for Good Laboratory Practice(GLP)-Part 1 :Quality assurance and GLP
2008-08-04 Issued
General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China Standardization Administration
Digital Anti-bypassing
2009-04-01 Implementation
GB/T22275 "Implementation Requirements for Good Laboratory Practice" is divided into 7 parts: Part 1: Quality Assurance and Good Laboratory Practice; Part 2: Tasks and Responsibilities of Project Leaders in Good Laboratory Practice Studies; Part 3: Compliance of Laboratory Suppliers with Good Laboratory Practice Principles; Part 4: Application of Good Laboratory Practice Principles in Field Studies; Part 5: Application of Good Laboratory Practice Principles in Short-term Studies; Part 6: Application of Good Laboratory Practice Principles in Computerized Systems; Part 7: Application of Good Laboratory Practice Principles in the Organization and Management of Multi-site Studies. This part is Part 1 of GB/T22275. GB/T 22275. 1—2008
This part is equivalent to the OECD Good Laboratory Practice (GLP) principles and compliance monitoring series document No. 4: Quality Assurance and GLP [ENV/JM/MONO(99)20]. The following editorial changes have been made to this part:
The foreword of the original text has been deleted:
The background part of the original text has been deleted.
This part was proposed and managed by the National Technical Committee for the Promotion of Dangerous Chemicals Management Standards (SAC/TC251). The drafting unit of this part: Shandong Exit-Entry Inspection and Quarantine Bureau. The main drafters of this part: Tao Qiang, Che Lidong, He Fei, Chen Huiming. I
1 Scope
Requirements for the implementation of good laboratory practice Part 1: Quality assurance and good laboratory practice
GB/T22275.1—2008
This part of GB/T22275 specifies the specific content and requirements of quality assurance activities under the GLP principles, including the responsibilities of quality assurance personnel, the relationship between quality assurance personnel and management, the qualifications of quality assurance personnel and the situation of participation in the formulation process of standard operating procedures and research plans, quality assurance inspections, plans for quality assurance activities and the demonstration of quality assurance activities and methods, reports on quality assurance inspections, review of data and final reports, quality assurance statements, quality assurance and quality assurance in non-regulated studies and small-scale test institutions. This part applies to quality assurance activities under the GLP principles. 2 Normative references
The clauses in the following documents become the clauses of this part through reference in this part of GB/T22275. 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/T 22274.1 Guidelines for Good Laboratory Practice Supervision Departments Part 1: Guidelines for Good Laboratory Practice Compliance Supervision Procedures GB/T 22278-2008 Principles of Good Laboratory Practice 3 Terms and Definitions
Terms and definitions in GB/T 22278-2008 and GB/T 22274.1 apply to this part. 4 Main Technical Specifications
4.1 Quality Assurance in the Principles of Good Laboratory Practice 4.1.1 Quality Assurance Plan is defined in the Principles of Good Laboratory Practice as "a clear system (including personnel) independent of the execution of the study to ensure that the management of the test organization complies with the GI.P source principles." (See 2.2.8 in GB/T 22278-2008). The responsibilities of the test institution manager include ensuring "a quality assurance plan is established with designated personnel in charge and ensuring that they perform quality assurance duties in accordance with GLP principles" [see 3.1.1.2f in GB/T22278-2008). In addition, the test institution manager should also ensure that "the project sponsor makes the approved research plan available to the quality assurance personnel" [see 3.1.1.2j in GB/T22278-2008)]. The responsibilities of the project leader should include ensuring that "during the study, the quality assurance personnel receive a copy of the study plan and any revised documents in a timely manner, and maintain effective communication with them as needed" [see 3.1.2.2b) in GB/T22278-2008]. The test institution manager should also ensure that when conducting multi-site studies, there are clear communication channels between the project leader, project representative, quality assurance plan personnel and researchers [see 3.1.1.20 in GB/T22278-2008)].
In 3.2 (Quality Assurance Plan) of GB/T22278-2008, the following requirements are listed: 4.1.2 General
4.1.2.1 The testing organization shall have a written quality assurance plan to ensure that the implemented research complies with the GLP principles. 4, 1.2.2 The quality assurance plan shall be implemented by one or more persons familiar with the test procedures designated by the management and directly responsible to the management. 4.1.2.3 Quality assurance personnel shall not participate in the implementation of the research for which they are responsible for quality assurance. 4.1.3 Responsibilities of quality assurance personnel
GB/T 22275. 1--2008
4.1.3.1 The responsibilities of quality assurance personnel shall include, but not be limited to, the following. They shall a) hold copies of all approved study plans and standard operating procedures used by the testing facility and have access to the latest version of the master input list; b) verify that the study plan contains the information required by the GLP principles, and the verification shall be recorded; c) inspect all studies to determine whether they are carried out in accordance with the GLP principles. The inspection shall also determine whether the researchers hold and follow the study plan and standard operating procedures; according to the standard operating procedures of the quality assurance plan, the inspection can be divided into three types: - study-based inspection;
- facility-based inspection d) Review the final report to verify that the methods, procedures, and observations are accurately and completely described, and that the reported results accurately and completely reflect the original data of the study; promptly report the inspection results in writing to the management, project leader, and, if applicable, the project representative and the management of each site. e) In the final report, prepare and issue a statement stating the type and date of the inspection, including the stage of the inspected study, and the date on which these inspection results were reported to the management, project leader, and project representative (if delegated). This statement also confirms that the final report reflects the original data. 4.1.4 GB/T22278-2008 3.7.4.5 mentioned: Among the standard operating procedures that laboratory activities should have, there is "planning, scheduling, implementation, recording and reporting of inspection activities by quality assurance personnel." 4.1.5 GB/T22278-2008 3.9.2.4 states that the final study report should include "a statement of the quality assurance plan that lists the types of inspections completed and the dates of the inspections, including the stages of the study that were inspected, and the date on which any inspection results were reported to the manager, project sponsor, and project representative (if delegated). This statement will also be used to confirm that the final report reflects the original data". 4.1.6 GB/T22278-2008 3.10.1b) states that "records of all inspections performed in accordance with the quality assurance plan, as well as the master schedule" should be kept in the archives for the period specified by the relevant departments. 4.2 Contact between quality assurance personnel and managers 4.2.1 The manager of the test organization is ultimately responsible for ensuring that all operations of its organization comply with the G1.P principles. Managers can delegate designated control activities through management organizations at all levels, but always bear full responsibility. The most basic management responsibility is to assign and effectively organize a sufficient number of appropriately qualified and experienced personnel, including those who specialize in performing quality assurance functions. 4.2.2 The facility manager who is ultimately responsible for GLP should be clearly designated. His or her position includes the assignment of appropriately qualified personnel for laboratory operations and for performing an independent quality assurance function. GLP management work assigned to quality assurance personnel should not compromise the independence of quality assurance work; and quality assurance personnel should not be involved in the conduct of individual studies except for their supervisory duties during the study. The designated personnel responsible for quality assurance should have direct access to management at all levels, especially the top management of the laboratory. 4.3 Qualifications of Quality Assurance Personnel
4.3.1 Quality assurance personnel should have the necessary training, skills and experience to perform their duties. They should be familiar with the laboratory's experimental operating procedures, test standards and test systems.
4.3.2 Personnel designated for quality assurance functions should have the ability to understand the basic concepts of the activities they supervise. They should also have a comprehensive understanding of GLP.
4.3.3 If expertise is lacking or if consultation is needed, it is recommended that expert support be sought when performing quality assurance. Management should also ensure that there is a written training program covering all aspects of quality assurance work. Where feasible, the training program should include: On-the-job training under the supervision of trained and competent personnel. Participation in internal and external seminars and courses is also possible (for example, training in communication skills2
and conflict management is recommended). Training should be continuous and reviewed regularly. GB/T22275.1--2008
4.3.4 Records should be kept of the training of quality assurance personnel and their competence should be evaluated. These records should be kept up to date and retained. 4.4 Involvement of quality assurance personnel in the development of standard operating procedures and study plans 4.4.1 Management should be responsible for the development, promulgation, distribution and maintenance of standard operating procedures. Quality assurance personnel are not usually involved in the drafting of standard operating procedures, but they can review them before they are put into use to assess whether they are clear and meet the requirements of GLP principles.
4.4.2 Management should ensure that quality assurance personnel receive the study plan before the start date of the study. This enables the quality assurance personnel to: a) monitor the study plan for compliance with G1.P; b) assess the clarity and coherence of the study plan; c) identify the key stages of the study; d) design a monitoring plan for the study. 4.4.3 Whenever the study plan is modified, a copy of the modified document should be submitted to the quality assurance personnel to enable effective study monitoring. 4.5 Quality Assurance Inspections
The quality assurance plan is generally based on the following types of inspections: a) Study-based inspections: This type of inspection schedule is arranged according to the progress of the study, usually starting with the identification of the key stages of the study;
b) Facility-based inspections: This type of inspection is not based on a specific study, but covers common facilities and activities within a laboratory (installation, support services, computer systems, training, environmental monitoring, maintenance and calibration, etc.); Process-based inspections: This type of inspection is also not related to a specific study. They are used to monitor procedures or processes of a repetitive nature, and usually these inspections are conducted randomly. This type of inspection is required when a process is frequently performed in the laboratory and cannot be effectively monitored through "study-based inspections". It should be noted that process-based inspections of phases with high frequency of occurrence may result in some studies not being inspected during the experimental phase. 4.6 Planning of Quality Assurance and Justification of Quality Assurance Activities and Methods 4.6.1 The quality assurance unit should plan its work appropriately. There should be standard operating procedures for the planning process of the quality assurance unit and the operation of quality assurance, including the implementation, recording and reporting of inspections. The quality assurance unit should have a list of planned and ongoing studies and should be provided with a copy of the latest master schedule. These tables and lists are essential for planning quality assurance activities and assessing the quality assurance workload.
4.6.2 As with any other operating procedure covered by the GLP principles, the quality assurance plan for inspections and audits should be submitted to management for confirmation. Both quality assurance personnel and management should be able to determine whether the methods selected are appropriate for the performance of their tasks. 4.7 Reports on Quality Assurance Inspections
GLP oversight may require information on the type and date of inspections, including the experimental phases inspected. However, the contents of quality assurance inspection reports are not usually reviewed by the GLP supervisory department because this would place constraints on the quality assurance personnel in writing inspection reports. However, the supervisory department may occasionally review the contents of inspection reports to verify that the quality assurance work has been fully implemented. However, they should not simply conclude that there are deficiencies in the study execution process simply by reviewing these reports. 4,8 Review of Data and Final Reports
4.8.1 Quality assurance personnel can use a variety of methods to review the raw data1 of the study project. For example, quality assurance personnel may check records during the experimental phase of the study, during the inspection process, or during the review of the final report. Management should ensure that all final reports that claim compliance with GLP principles are reviewed by quality assurance personnel. The review of the final report should be conducted during the drafting stage of the final report, when all the original data have been summarized and no major changes are expected. 4.8.2 The purpose of the final report review is to confirm whether: a) the study was conducted in accordance with the study plan and standard operating procedures; the study was accurately and completely reported; the report contains all the elements required by GLP; c) the report content is coherent and consistent; and the original data are complete and in accordance with GLP.
4.8.3 The quality assurance personnel may find it advisable to record the results of the final report review in as much detail as possible in a table format, which will assist in the review. Procedures should be established to enable the quality assurance personnel to identify any additions or changes made to the study data and reports during the review stage.
4.8.4 Before signing the quality assurance statement, the quality assurance personnel should ensure that all issues raised during the quality assurance review have been appropriately addressed in the final report, that any corrective actions have been completed, and that the report does not require modification or further review. 4.8.5 Any corrections and additions to the completed final report should be reviewed by the quality assurance personnel. At this time, a revised or supplemented quality assurance statement should be provided.
4.9 Quality Assurance Statement
4.9.1 GLP principles require that the final report contain a signed quality assurance statement that specifies the type and date of the inspection, including the phase of the study inspected, and the date when the inspection results were reported to the management, the project leader, and the project representative (if delegated) [see 3.2.2f) and 3.9.2.4 of GB/T 22278-2008]. Management should be responsible for establishing procedures to ensure that this statement reflects the quality assurance personnel's acceptance of the project leader's GLP compliance statement and that it is associated with the published final study report.
4.9.2 The format of the quality assurance statement should be consistent with the type of report. The statement should include full study identification information and the date and phase of relevant quality assurance monitoring activities. If individual study-based inspections were not performed according to the quality assurance plan, the statement should detail the monitoring inspections that were performed. For example, in short-term studies, it would be inefficient or impractical to repeat the inspections for each study. 4.9.3 It is recommended that the quality assurance statement be completed only after the project leader's statement of GLP compliance has been confirmed. The quality assurance statement will also be used to confirm that the final report reflects the original data. The project leader should also ensure that any non-compliance with GLP principles is noted in the final report.
4.10 Quality Assurance and Non-Regulated Studies
4.10.1 Compliance with GLP is a regulatory requirement for the approval of certain studies. However, some sites conduct two types of studies in the same area, i.e. studies intended for regulatory submission and other studies not intended for this purpose. If the latter are not conducted to standards equivalent to GLP, this will generally have a negative impact on the GLP compliance of the regulated studies. 4.10.2 The list of studies maintained by the quality assurance department should distinguish between regulated and non-regulated studies so that an accurate assessment of the workload, available facilities and possible interference factors can be made. The quality assurance department should keep an up-to-date master schedule to facilitate its work. Once a non-GLP study has been started, it may not be changed to a GLP study. If a GLP study is to be changed to a non-GLP study, this should be recorded in detail. www.bzxz.net
4.11 Quality Assurance in Small Facilities 4.11.1 In some small facilities, it is not practical for management to maintain a full-time quality assurance staff. However, management should arrange for at least one permanent person to be responsible for the coordination of the quality assurance function, even if it is part-time. It is necessary to maintain a certain continuity of quality assurance personnel, which is conducive to the accumulation of professional knowledge and to ensure the consistency of interpretation. Personnel involved in GLP studies are allowed to perform quality assurance functions for GLP studies in other departments of the laboratory. It is also permissible for personnel outside the testing organization to assume the responsibility for quality assurance, provided that effectiveness in accordance with the GLP principles can be ensured. 2 The concepts of this standard can also be applied to multi-site studies, such as field studies, provided that the overall coordination responsibilities are clearly defined.
GB/T22275.1-2008
National Standard of the People's Republic of China
Requirements for the Implementation of Good Laboratory Practice
Part 1:
Quality Assurance and Good Laboratory Practice
GB/T22273.1—2008
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