GB/T 22275 "Requirements for the Implementation of Good Laboratory Practice" is divided into 7 parts, and this part is Part 5 of GB/T 22275. This part of GB/T 22275 specifies the organization and personnel, quality assurance plan, facilities, test system, test samples and reference materials, standard operating procedures, implementation of the study and reporting of the results of the short-term study. Except for explicit exemptions from national legislation, the good laboratory practice principles (hereinafter referred to as 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. GB/T 22275.5-2008 Requirements for the implementation of good laboratory practice Part 5: Application of good laboratory practice principles in short-term studies GB/T22275.5-2008 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 5th part of GB/T 22275. This part of GB/T 22275 specifies the organization and personnel, quality assurance plan, facilities, test system, test samples and reference materials, standard operating procedures, implementation of the study and reporting of the results of the short-term study. Except for explicit exemptions in national legislation, the good laboratory practice principles (hereinafter referred to as 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.
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 5 of GB/T22275.
This part is equivalent to the OECD Good Laboratory Practice (GLP) principles and compliance monitoring series document No. 7: Application of GLP principles in short-term studies [ENV/JM/MONO(99)23].
This part has been edited as follows:
--- The foreword, introduction and directory have been deleted.
This part was proposed and managed by the National Technical Committee for the Administration of Hazardous Chemicals (SAC/TC251).
The drafting unit of this part: Shandong Entry-Exit Inspection and Quarantine Bureau.
The main drafters of this part: Huang Honghua, Tao Qiang, Che Lidong, He Fei, Jia Juntao, Chen Huiming.
The provisions in the following documents have become the provisions of this part through reference in this part of GB/T 22275. 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 study whether the latest versions of these documents can be used. For undated references, the latest versions apply to this part.
GB/T22275.1 Implementation requirements for good laboratory practice Part 1: Quality assurance and good laboratory practice
GB/T22278-2008 Principles of good laboratory practice

ICS 03. 120. 20
National Standard of the People's Republic of China
GB/T22275.5--2008
Reguirements of conduct for Good Laboratory Practice (GLP)-Part 5: The application of the GLP principles to short term studies2008-08-04 release
General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China Standardization Administration of China
Digital anti-counterfeiting
2009-04-01 implementation
GB/T22275 "Good laboratory practice implementation requirements are 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. GB/T 22275.5--2008
This part is Part 5 of GB/T22275. This part is equivalent to the Organization for Economic Cooperation and Development (OFCD) Good Laboratory Practice (GLP) principles and compliance monitoring series document N.7: "Application of GLP principles in short-term studies" [ENV/JM/MONO(99>23]. This part has made the following editorial changes:
Deleted the foreword, introduction and self-recording part. This part was proposed and coordinated by the National Technical Committee for the Management of Hazardous Chemicals (SAC/TC251). The drafting unit of this part: Shandong Exit-Entry Inspection and Quarantine Bureau. The main drafters of this part: Huang Honghua, Tao Qiang, Che Lidong, He Fei, Jia Juntao, Chen Huiming. I
1 Scope
Good laboratory practice implementation requirements
Part 5: Good laboratory practice principles
Application in short-term studies
GB/T22275.5—2008
This part of GB/T22275 specifies the organization and personnel of the test institution for short-term studies, quality assurance plans, facilities, test systems, test samples and reference materials, standard operating procedures, implementation of studies and reporting of study results. Except for explicit exemptions in national legislation, the good laboratory practice principles (hereinafter referred to as 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 referenced documents
The provisions in the following documents are adopted by this part of GB/T22275. The terms of this part are formed by reference to the parts. 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 investigate whether the latest versions of these documents can be used. For any undated referenced document, the latest version applies to this part. GB/T 22275.1 Requirements for the implementation of good laboratory practice Part 1: Quality assurance and good laboratory practice 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 part of GB/T 22275. 4 Main technical specifications
4.1 Organization and personnel of the testing agency
4 .1.1 Responsibilities of the research facility management
The management shall ensure that a person with appropriate qualifications, training and experience is appointed as the project leader before the start of each study. The replacement of the project leader shall be carried out according to the established procedures and recorded. Note: The appointment of the project leader is a key factor in ensuring that the study is properly planned, executed and reported. The appropriate qualifications of the project leader depend more on experience than on education.
4.2 Quality Assurance Plan
4.2.1 General
The research facility shall have a written quality assurance plan to ensure that the studies conducted comply with the principles of GLP. Note 1: The "quality assurance plan" mentioned in this standard should be interpreted in accordance with GB/T 22278·2008 and GB/T 22275.1. For physical-chemical studies, other published standards (such as ISO 9000 series) have different definitions of quality assurance. Note 2: The quality assurance plan document should include a description of the study-based, facility-based, and process-based inspections defined in CB/T 22275.1. These definitions are as follows:
Study-based inspections: This type of inspection schedule is arranged according to the progress of the study, usually first determining the key stages of the study.
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.):
GB/T 22275. 5—2008
This type of inspection is also not related to a specific study. They are used to monitor procedures or processes of a repetitive nature, usually 1
GB/T 22275. 5—2008
This type of inspection is conducted randomly. This type of inspection is required when a process is frequently performed in the laboratory and cannot or cannot be effectively monitored through "study-based inspections". It should be noted that process-based inspections of high-frequency stages may result in some studies being inspected during the experimental stage. 4.2.2 Responsibilities of Quality Assurance Personnel
The responsibilities of quality assurance personnel should include, but are not limited to, the following responsibilities. They should: a) Have copies of all approved study plans and standard operating procedures used by the testing agency and have access to copies of the latest version of the master schedule.
b) Verify that the study plan contains requirements that meet the requirements. Information on GLP principles should be recorded during the verification. c) All studies should be inspected to determine whether they are carried out in accordance with GLP principles. The inspection should also determine whether the researchers have followed the study plan and standard operating procedures.
Note: Due to the high frequency and routine nature of some standard short-term studies, it is considered in GB/T22275.1 that not every study needs to be individually inspected by quality assurance during the trial phase of the study. In this case, a process-based inspection plan can be applied to each type of study. Taking into account the number, turnover rate and/or complexity of the studies conducted by the institution, the frequency of process-based inspections should be within the established The frequency of inspections should be detailed in the relevant quality assurance standard operating procedures, and there should be standard operating procedures to ensure that all these processes are regularly inspected.
d) In the final report, prepare and issue a statement detailing the type and date of the inspections; if applicable, the phase of the study inspected, and the date these inspections were reported to the supervisor, study leader and project representative. This statement is used to confirm that the final report reflects the original data. Note: If no separate study-based inspections were performed, the quality assurance statement should clearly describe the inspections that were performed. The type of checks to be performed (e.g., process-based checks) and their timing should be clearly stated in the quality assurance statement. The final report should be reviewed. 4.3 Facilities
4.3.1 The experimental facilities should be of appropriate size, structure and location to meet the needs of the study and minimize interference factors that may affect the validity of the study.
4.3.2 The design of the experimental facilities should provide appropriate separation for different activities to ensure the correct execution of each study. Note: The main concern of biological in vitro studies is the possibility of contamination of the test system. The laboratory should establish facilities and procedures to ensure the prevention and/or control of such potential contamination
4.4 Instruments, materials and reagents
The instruments used in the study should be regularly inspected, cleaned, maintained and calibrated according to standard operating procedures. Records of these activities should be retained. Where appropriate, calibration should be traceable to national or international measurement standards. Note: Where appropriate, calibration should provide the source of the basic physical quantity retained by the relevant national authorities. Instruments should be checked regularly to ensure the continued accuracy of their measurements. Calibration materials should be used as reference materials, but they do not need to be retained. 4,5Test system
4.5.1 Physical-Chemical
Equipment used in a physical-chemical test system should be regularly inspected, cleaned, maintained, and calibrated according to standard operating procedures. 4.5.2 Biological Systems
4.5.2.1 Appropriate environmental conditions should be established and maintained for the storage, placement, handling, and management of biological test systems to ensure data quality.
4.5.2.2 Newly received animal and plant test systems should be isolated before their health status is assessed. If mortality or morbidity is abnormal, the test system cannot be used for research and should be destroyed humanely when appropriate. After the start date of the experiment, the test system should be removed from disease or conditions that may affect the results or performance of the research. If the integrity of the research is to be maintained, the test system during the research should be isolated and treated for disease or injury. Diagnosis and treatment before or during the research should be recorded. 4.5.2.3 Records of the source, receipt date, and arrival of the test system should be maintained. 4.5.2.4 Before the first administration of the test sample or reference material to the test system and (or >) the application of the test system, the system should be given sufficient time to adapt to the test environment.
GB/T22275.5-2008
4.5.2.5 All information required to correctly identify the test system should be marked on its culture environment or container. If a single test system should be removed from its culture environment or container during the study, it should be marked with appropriate identification information whenever possible. 4.5.2.6 The culture environment or container of the test system should be kept sanitary and cleaned regularly during use. Any material that comes into contact with the test system should not contain contaminants at doses that may interfere with the study. Animal bedding should be changed in accordance with the requirements of reliable agricultural and livestock quality management practices. The use of pesticides should be to be recorded.
Note 1: Information on the test system: For in vitro research test systems, the growth, vitality, and freedom from contamination of each batch of the system should be documented. It is very important to identify and record the source, substrain, and maintenance of the system in in vitro studies. Note 2: Characteristics of test systems used primarily for in vitro studies: It should be ensured that the test system described in the research plan is used and that the test system is free of contamination. This can be achieved by regular genetic marker testing, chromosome karyotype testing, or mycoplasma testing. Note 3 Isolation of the test system: In short-term biological studies, isolation of animal or plant test systems may not be required. The standard operating procedures of the test institution should detail the procedures used for health status assessment (e.g. historical colony and donor information, observations, serum evaluations ) systems and follow-up actions. Note 4: Control of dry substances in in vitro studies: During the study, it should be ensured that water, glassware and other laboratory equipment do not contain substances that interfere with the conduct of the test. To achieve this goal, a control group should be included in the study plan; the system can also be tested regularly to help achieve this goal. Note 5: Characteristics of culture media: The type, composition and batch number of media (such as antibiotics, blood, etc.) should be recorded. The standard operating procedures should state who prepared and received these media. Note 6: Use of test systems: In certain specific cases, some member states recognize the reuse of one animal or the simultaneous conduct of multiple tests on one animal. The GLP principle is that in all cases a complete history of the previous use of animals should be kept and recorded in the standard operating procedures. mentioned in the final report. It should also be documented that these actions do not affect the evaluation of the test samples. 4.6 Test samples and reference materials
4.6.1 Each test sample and reference material should be appropriately labeled, such as code, Chemical Abstracts Registration Number (CAS number), product name, biological parameters. 4.6.2 For each study, identification information that can appropriately define each batch of test samples and reference materials should be listed, including: batch number, purity, composition, concentration and other characteristics. 4.6.3 When the test samples are provided by the client, a cooperative mechanism should be established between the client and the test organization to verify the properties of the test samples used in the study
4.6.4 The stability of the test samples and reference materials under storage and test conditions in all studies should be understood. 4.6.5 For test samples that may be administered and/or applied using a medium, their homogeneity, density and stability in the medium should be determined. For test samples in field studies, such as tank mixes, these properties can be determined separately in the experimental air experiment. 4.6.6 For all studies except short-term studies, a reserve sample from each batch of test samples should be retained for analysis. NOTE 1 Adequate characterization information should be available for each batch of test samples and reference materials. To facilitate mutual recognition between all Member States, it is recommended that this information be generated in accordance with the requirements of GB/T 22278-2008, where necessary. If the test sample is in the early stages of development, characterization analysis can be carried out after the biological studies have been carried out. However, some chemical structure information of the test sample should be available before the start date of the study. NOTE 2 To facilitate mutual recognition between all Member States, it is recommended that the stability of the test sample and reference material under storage conditions should be determined in accordance with the GLF principles, where necessary. NOTE 3 The requirements for the evaluation of the concentration, stability and homogeneity of the test sample in the medium vary considerably between Member States. In addition, for some short-term biological tests, it is not always possible to perform such analysis at the same time. For some tests, it may not make sense to determine the stability of a normally stable substance when only a few minutes separate its preparation and application. For the reasons mentioned above, it is necessary to describe and approve the analytical requirements in the study plan and clearly indicate them in the final report. 4: For the characteristic data of the test samples and reference materials mentioned in 4.6.4 and 4.6.5 of this part, if the physical-chemical studies are used to determine these data, these data do not need to be known in advance. 4.7 Standard operating procedures
Note: In 3.7.4.4 of GB/T 22278-2008, the illustrative examples given mainly involve biological test systems, which may not be related to the physical-chemical studies mentioned in this part. The implementation of physical-chemical studies also requires standard operating procedures, which requires the test institution manager to ensure that appropriate standard operating procedures are developed and applied to the physical-chemical studies conducted in the test institution. 4.8 Conduct of the study 4.8.1 Study plan 4.8.1.1 For each study, a written study plan shall be prepared before the study is started. This study plan shall be approved by the project manager by signing the name and date and shall be checked for GLP compliance by the quality assurance personnel (see 4.2.2 b) 1. If the laws and regulations of the country where the study is to be conducted require this, the study plan shall also be approved by the test facility management and the sponsor. 4.8.1.2 For short-term studies, a general study plan may be supplemented by specific supplementary study plans. NOTE 1 If a particular short-term study or a series of similar studies is to be carried out regularly in a laboratory, a single general study plan should be prepared. This plan should include most of the major information retained and should be approved in advance by the test facility manager, the project leader responsible for execution and the quality assurance personnel. bzxZ.net
Note 2: Specific supplements to the study plan (e.g., details of the test samples, the start date of the experiment) should be a supplementary document, and its issuance only requires the signature and date of the designated project leader. The study plan includes the general study plan and the supplementary study plan. It is important that the supplement to the study plan is submitted to the test facility manager and quality assurance personnel as soon as possible. Contents of the study plan
Note: The complete content of the study plan (i.e., the general study plan and the supplementary study plan) is detailed in CB/T22278-2008, and possible exceptions are shown in the "Note" below.
The research plan should include, but is not limited to, the following information: 4.8.2.1 Identification information of the study, test and reference material a) Descriptive title;
b) Statement of the nature and purpose of the study:
Note: if the relevant information is already provided in the descriptive title, b) information is not required. c) Identification of the test sample by number or product name (such as IUPAC number, CAS number, biological parameters, etc.); d) Reference material to be used.
4.8.2.2 Related issues (when applicable)
Justification for the selection of the test system:
a) Characteristics of the test system, such as species, strain, substrain, source of supply, quantity, weight range, sex, age and other relevant information;
Method of drug administration or administration and the reason for its selection; b
c) Dose level and (or) concentration, frequency and duration of drug administration and (or) administration; Note: from a) to),This may not be required for physico-chemical studies. d) Detailed information on the experimental design, including a description of the timing of the study, all methods, materials and conditions, the types and frequency of analyses, measurements, observations and tests to be performed, and the statistical methods to be used (if any). NOTE This will normally be given in a short, abstract table or by reference to an appropriate standard operating procedure or test guide. 4.9 Reporting of study results
4.9.1 General
A final report should be produced for each study. For short-term studies, a standardized final report may also be issued with the specific scope of the study. NOTE If short-term studies are conducted according to a general study plan, a standardized final report should be issued that contains most of the essential information required and has been authorized in advance by the management of the test site and the project sponsor responsible for carrying out the study. Extensions to the final report that are difficult to standardize for a particular study (details of the test samples, numerical results obtained) may be issued as a supplement to this report and need only be signed and dated by the project sponsor. If the study plan is revised before or during the study, the standardized final report cannot be used unless the standardized final report has also been revised accordingly. 4.9.2 Contents of the final report
Note: The contents of the complete final report (i.e., the standardized final report and the special study supplementary report) are detailed in B/T22278--2008, with exceptions as described below\Note". The final report should include but is not limited to the following information: 4.9.2.1 Identification of the study, test and reference material: a) Descriptive title; b) Identification of the test sample by number or product name (such as IUPAC number, CAS number, biological parameters, etc.); e) Identification of the reference material by chemical name; d) Characteristics of the test sample, including purity, stability and homogeneity. Note: This may be meaningless when the study is intended to determine these data. 4
2 Declaration
4.9. 2. 2
GB/T 22275.5—2008
A statement of the quality assurance program listing the types of inspections completed and the dates of the inspections, including the study phases inspected, and the dates when any inspection results were reported to management, the project leader, and the project representative (as applicable). This statement will also be used to confirm that the final report reflects the original data.
Note: This may reflect the use of process-based inspections. The quality assurance statement must clearly indicate that the final report has been reviewed, as described in the note to 4.2.2d).
GB/T22275.5-2008
People's Republic of China
National Standard
Good Laboratory Practice Implementation Requirements
Part 5: Application of Good Laboratory Practice Principles
In Short-term Studies
CB/T22275.5—2008
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