GB/T 22275 "Requirements for the Implementation of Good Laboratory Practice" is divided into 7 parts, and this part is Part 2 of GB/T 22275. This part of GB/T 22275 specifies the tasks, appointment, training, responsibilities, qualifications, and legal status of the project leader. Except for explicit exemptions in national legislation, the GLP principles specified in this part apply to all non-clinical health and environmental safety studies required by regulations, including the registration or application for licenses for pharmaceuticals, pesticides, food additives and feed additives, cosmetics, veterinary drugs and similar products, as well as industrial chemical management. This part has made the following editorial changes: --- The foreword and the directory have been deleted. GB/T 22275.2-2008 Requirements for the implementation of good laboratory practice Part 2: Tasks and responsibilities of the project leader in good laboratory practice studies GB/T22275.2-2008 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 second part of GB/T 22275. This part of GB/T 22275 specifies the tasks, appointment, training, responsibilities, qualifications and legal status of the project leader. Except for explicit exemptions in national legislation, the GLP principles specified in this part apply to all non-clinical health and environmental safety studies required by regulations, including the registration or application for licenses of pharmaceuticals, pesticides, food additives and feed additives, cosmetics, veterinary drugs and similar products, and industrial chemical management. This part has made the following editorial changes: ——The foreword and the directory have been deleted.
class="f14" style="padding-top:10px; padding-left:12px; padding-bottom:10px;"> 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 2 of GB/T22275.
This part is equivalent to the OECD Good Laboratory Practice (GLP) Principles and Conformity Monitoring Series Document No. 8: "Tasks and Responsibilities of the Project Leader in GLP Studies" [ENV/JM/MONO(99)24].
This part has been edited as follows:
--- The foreword and the contents have been deleted.
This part was proposed and managed by the National Technical Committee for the Administration of Dangerous Chemicals (SAC/TC251).
The drafting unit of this part: Shandong Entry-Exit Inspection and Quarantine Bureau.
The main drafters of this part: Che Lidong, Wan Min, Yu Xiao, Yu Wenlian, Tang Zhixu, Wang Xiaobing.
The provisions in the following documents have become the provisions of this part through reference in this part of GB/T 22275. For all 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 study whether the latest versions of these documents can be used. For all undated references, the latest versions apply 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 22275.2—2008
Requirements of conduct for Good Laboratory Practice(GLP)-Part 2: The role and responsibilities of the study directorinGLPstudies
2008-08-04 Issued
General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China
Standardization Administration of the People's Republic of China
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 the Project Director in Good Laboratory Practice Research; Part 3: Compliance of Laboratory Suppliers with Good Laboratory Practice Principles; Part 4: Application of Good Laboratory Practice Principles in Field Research; Part 5: Application of Good Laboratory Practice Principles in Short-term Research; 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 Research. This part is Part 2 of GB/T22275. GB/T 22275.2—2008
This part is equivalent to the original and conformity monitoring series document No. 8 of the Organization for Economic Cooperation and Development (OECD) Good Laboratory Practice (GLP): Tasks and Responsibilities of the Project Leader in GLP Studies>[ENV/JM/MONO(99)24. The following editorial changes have been made to this part:
The foreword and the directory have been deleted.
This part was proposed and managed 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: Che Lidong, Wan Min, Yu Xiao, Yu Wenlian, Tang Zhixu, Wang Xiaobing. I
1 Scope
Requirements for the implementation of good laboratory practice
Part 2: Tasks and responsibilities of the project leader in good laboratory practice studies
GB/T 22275.2—2008
This part of GB/T 22275 specifies the tasks, appointment, training, responsibilities, qualifications and legal status of the project leader. Except for the explicit exemptions in national legislation, the GLP principles specified in this part apply to all non-clinical health and environmental safety studies required by regulations, including the registration or licensing of pharmaceuticals, pesticides, food additives and feed additives, cosmetics, veterinary drugs and similar products, and industrial chemical management.
2 Normative references
The provisions of the following documents become the provisions of this part through reference to this part of GB/T 22275. For all 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 edition applies to this part.
0B/T22278 Principles of Good Laboratory Practice
3 Terms and definitions
Terms and definitions in GB/T22278 apply to this part. 4 Main technical specifications
4.1 Tasks of the project leader
4.1.1 The project leader is the sole controller of the research and is ultimately responsible for the comprehensive and scientific execution of the research. This is the main task of the project leader. The obligations and responsibilities set out in the GIP principles are derived from this main task. Experience has shown that only by delegating the responsibility for the correct conduct of the research to a dedicated person can the researchers avoid receiving conflicting instructions that may lead to poor execution of the research plan. There can only be one project leader for a study at any given time. Some of the project leader's responsibilities can be delegated, for example in subcontracted research, but the project leader's ultimate responsibility as the single center controller of the research cannot be delegated. 4.1.2 In this regard, the project leader should ensure that the scientific, administrative, and regulatory aspects of the study are under control. The project leader controls the study by coordinating with management, scientific and/or technical personnel, and the quality assurance plan. 4.1.3 In a multi-site study involving multiple sites, if the project leader cannot exercise direct supervision, control of the study process can be transferred to a trained, qualified and experienced person, namely the project representative. The project representative is responsible for the implementation of specific stages of the study in accordance with applicable GLP principles on behalf of the project leader. 4.1.4 From a scientific perspective, the project leader is usually the technical expert who is responsible for designing and approving the study plan and supervising the collection, analysis and reporting of data. The project leader is responsible for drawing the final conclusions based on the study. As the chief technical expert, the project leader should coordinate with other technical experts and/or project representatives to understand their findings during the study, receive and evaluate their respective study reports and include them in the final study report.
4.1.5 From an administrative perspective, the project leader should request resources (such as personnel, equipment and facilities) from management and coordinate to ensure that the expected study progresses normally. 4.1.6 It is also the responsibility of the project leader to ensure that the study is conducted in accordance with the regulations. In this role, the project leader is responsible for ensuring that the study is conducted in accordance with the principles of GLP. This requires the project leader to sign the final study report to confirm that the principles of GLP were followed. 4.2 Management's responsibilities The person who manages the research facility has the responsibility to ensure that the facility is run in accordance with the principles of GLP. This responsibility includes the appointment and effective organization of sufficient appropriately qualified and experienced personnel in the research facility, including the project leader and the project representative (if required) for multi-site studies. 4.2.1 Appointment of the project leader 4.2.1.1 The management should provide an institutional document that specifies the procedures for the selection and appointment of the project leader, the project leader's deputy, and the project representative (if required by national procedures). 4.2.1.2 When appointing a project leader, management should be aware of their current and expected workload. A master schedule that includes information on the types of studies and time allocated to each project leader can be used to assess the workload of individuals within the facility and is a useful management tool when allocating research tasks.
4.2.1.3 Replacement of project leaders and/or project representatives should be made according to established procedures and should be documented. 4.2.2 Training of project leaders
4.2.2.1 Management should ensure that the training of project sponsors in all aspects of their work is documented. The training program should ensure that the project leader has a thorough understanding of GLP principles and appropriate knowledge of the facility's operating procedures. This may include knowledge and working knowledge of other guidelines and regulations relevant to the facility and specific types of studies, such as OECD test guidelines. Training may include work experience under the supervision of a competent person. Observation periods or work experience in each discipline involved in the research can provide a useful basic understanding of relevant practical aspects and scientific principles and help to establish communication channels. Attending seminars or courses within and outside the institution, participating in professional groups, and reading appropriate literature will help the project leader to understand the development of their scientific field. The professional development of the project leader should be continuous and require regular review and evaluation. All training should be recorded and the training records should be retained for a period of time specified by the relevant departments. 4.2.2.2 The record of the training program should reflect the progress of training and clearly indicate the type of research for which the individual is considered competent. Up-to-date training or retraining may be necessary, for example, after the introduction of new technologies, procedures or regulations. 4.3 The voice of the project leader
The project leader has overall responsibility for the scientific conduct of a study and can confirm that the study follows the principles of good laboratory practice. 4.3.1 Initiation of the study
4.3.1.1 The project leader shall approve the study and initiate the previously prepared research plan by signing his name and date. The planning document should clearly state the purpose of the study, the overall implementation of the study and how the purpose will be achieved. Any changes to the research plan should be approved in accordance with the above procedures. In a multi-site study, the study plan should describe and identify the roles of the project representative, any testing agency, and the testing sites involved in the conduct of the study.
4.3.1.2 The project sponsor shall take responsibility for the study plan by signing his name and date, and the study plan becomes the official working document for the study (i.e. the study start date). If required by the national plan, the project leader shall also ensure that the study plan has been signed by the sponsor and the test site management.
4.3.1.3 Before the study start date, the project leader shall ensure that the study plan is available to quality assurance personnel so that they can verify that the study plan contains all the information required by the GLP principles. 4.3.1.4 Before the study start date, the project leader shall ensure that a copy of the study plan is provided to all personnel involved in the study, including quality assurance personnel.
4.3.1.5 Before undertaking any work on the study, the project sponsor shall determine that the management has provided sufficient resources for the implementation of the study and that sufficient test materials and reduction systems are in place. 4.3.2 Implementation of the study
4.3.2.1 The project leader is responsible for the overall implementation of the study. The project leader shall ensure that the study process follows the procedures set out in the study plan and its amendments, and that all data generated during the study are recorded. Specific technical responsibilities may be delegated to competent individuals and recorded.
4.3.2.2 During the course of the study, the involvement of the project leader should include reviewing the study process and data (including computer-generated data) to ensure that the procedures established in the study plan are followed and that relevant standard operating procedures are complied with. The type and frequency of review should be recorded in the study records.
GB/T22275.2—2008
4.3.2.3 Since all decisions affecting the integrity of the study should ultimately be approved by the project leader, it is very important that the project leader maintains a clear understanding of the progress of the study. This is particularly important when the project leader is temporarily away from the study. The project leader can only grasp the progress of the study if he maintains effective communication with the relevant scientific, technical, management and project representatives involved in the multi-site study. This communication should ensure that deviations from the study plan are communicated in a timely manner and that problems are recorded. 4.3.2.4 If data are recorded on paper, the project leader should ensure that the data generated are recorded comprehensively and accurately and that the data are generated in accordance with GLP principles. The project leader has the same responsibilities for electronic data recorded on a computerized system. In addition, the project leader should ensure that the computerized system is suitable for the intended research purpose and has been validated for use in the research process. 4.3.3 Final Report
4.3.3.1 The final report of the study should be a detailed scientific and technical document that lists the purpose of the study, describes the methods and materials used, summarizes and analyzes the data generated, and explains the conclusions drawn. 4.3.3.2 Only when the project leader is satisfied that the report fully, truthfully and accurately reflects the study and its results can he sign his name and date the report to indicate his responsibility for the validity of the reported data. The extent to which the GLP principles are followed should also be stated in the report. The project leader should also ensure that the report contains a quality assurance statement and that any deviations from the study plan are noted. 4.3.4 Archives
At the completion of a study (including termination), the project leader is responsible for ensuring that the study plan, final report, raw data and related materials are archived in a timely manner. The final report should include a statement of the storage location of all test samples, reference materials, specimens, raw data, study plans, final reports and other related documents. Once the data is transferred to the archiving agency, the relevant responsibility should be borne by the manager of the test agency. 4.3.5 Subcontracting
When any part of the study is subcontracted to another agency, the project sponsor (and quality assurance personnel) should be aware of the subcontractor's compliance with GLP principles. If the subcontractor does not comply with GLP principles, the project leader should state this in the final report. 4.4 Modifications and deviations from the study plan
4.4.1 Research Modifications to the Study Plan
Modifications to the study plan should be documented as an intentional change after the study begins and before the plan is formally modified. A modification document should also be issued when unexpected events occur during the study and major actions are required. Modifications to the study plan should state the reason for the change and be consecutively numbered, dated, signed, and distributed to all personnel holding the original study plan by the project leader. 4.4.2 Deviations from the Study Plan
A deviation from the study plan is an unintentional deviation that occurs during the execution of the study. Information about deviations from the study plan should be noted in the study documents. This notation can be completed by other personnel involved in the study, but it should be promptly understood, described, explained, and dated by the project leader and/or project representative, and saved with the original data. Project Responsible The person in charge should approve any corrective actions taken. The project leader should consider whether to discuss with other technical experts to determine the relevant impact, and should describe (if necessary) these deviations in the final report.
4.5 Qualifications of the project leader
The qualifications of the project leader will be specified by the requirements of each study. Management is responsible for establishing relevant qualification standards. Management is responsible for selecting, supervising and supporting project leaders to ensure that the study is conducted in accordance with GLP principles. Any minimum qualification requirements for project leaders established by management should be recorded in the personal file. In addition to a strong technical background, the coordinating role of the project sponsor dictates that he should have strong communication, problem-solving and management skills. 4.6 Coordination of the study process
4.6.1 The project leader is generally responsible Conduct of the study. For studies where the project leader is geographically remote from the laboratory site, the definition of "responsible for the overall execution and final reporting of the study" can be interpreted in a broader sense. For managers at all levels, researchers and quality assurance personnel, it is critical that there are clear boundaries of authority, communication and delegated responsibilities so that the project leader can effectively fulfill GLP responsibilities. This should be documented. For multi-site studies, the laboratory manager should ensure that there are clear channels of communication between the project leader, the project representative, the quality assurance plan and the researchers. GB/T22275.2—2008
4.6.2 For studies where a project representative has been assigned, the project leader will rely on the project representative to ensure that the relevant study phases are carried out in accordance with the study plan, standard operating procedures, and GLP principles. If an event occurs that may affect the study objectives, the project representative should contact the project leader, and all communications should be documented: 4.6.3 During all stages of the study, the project leader should maintain communication with quality assurance personnel. Communication may include: a) Active involvement of the quality assurance personnel in the study, such as timely review of the study plan, participation in the review of new and revised standard operating procedures, participation of the quality assurance personnel in the study start-up meeting and resolution of potential issues related to GLP; the project leader promptly responds to inspection and audit reports, proposes corrective actions, and maintains contact with the quality assurance personnel and scientific and technical personnel to respond to inspection/audit reports as necessary. 4.7 Replacement of the Project Sponsor 4.7.1 The project leader is responsible for the overall execution of the study in accordance with GLP principles. The project leader should ensure that GLP principles are followed at every stage of the study, that the study plan is strictly followed, and that all observations are fully recorded. In theory, the project leader should be present throughout the study to fulfill his or her responsibilities. In practice, this is difficult to achieve. It may be necessary to replace the project leader after a period of absence. Although the GLP principles do not specify under what circumstances the project sponsor should be replaced, practical provisions should be made in the standard operating procedures of the testing organization. The procedures and documents used to replace the project sponsor should also be stated in the standard operating procedures. 4.7.2 The decision to replace or temporarily appoint a Project Leader is the responsibility of management. All decisions should be documented in writing. There are two situations in which replacement may be considered, both of which are particularly important in long-term studies, as in short-term studies it can be assumed that the Project Leader will be available at all times.
4.7.3 The first situation is if the employment of the Project Leader is terminated and the replacement of this key individual is obvious. In this case, one of the responsibilities of the successor Project Leader is to ensure, with the assistance of the quality assurance personnel, that the completed study complies with the GLP principles as quickly as possible. The replacement of the Project Leader and the reasons for it should be documented and approved by management. If deficiencies and deviations are found, it is recommended that the results of any GLP review during the transition period be recorded. 4.7.4 The second situation is when the PI is temporarily absent because of vacation, scientific conference, illness or accident. If the PI can be communicated with in case of problems or emergencies during the study, there is no need to formally replace the PI for a short absence. If a critical study phase is expected to coincide with the PI's absence, the phase can be moved to a more appropriate time (if necessary, by modifying the study plan) and a replacement of the PI can be considered. Replacement can be achieved by formally appointing a replacement PI or by temporarily delegating responsibilities to a competent person for this particular study phase. If the PI's absence lasts longer, the PI should be replaced rather than delegated to a competent person. 4.7.5 Regardless of whether the PI is formally replaced during the absence, the PI should confirm as soon as possible after his return whether any non-compliance with GLP principles has occurred. If so, the returning PI should record any deviations from GLP principles during the absence. 4.8 Legal status of the PI
The PI confirms that the study was conducted in accordance with GLP principles by signing the final report and assumes responsibility for conducting the study in accordance with GLP principles and for providing accurate raw data in the final report. The legal responsibilities of the project leader are determined by national laws and legal procedures. Copyright reserved
Book number: 1550661-34012
GB/T 22275.2-2008
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People's Republic of China
National Standard
Good laboratory practice implementation requirements
Part 2: Tasks and responsibilities of project leaders in good laboratory practice research
GB/T 22275. 2—2008bzxz.net
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