After 15 years, the management measures for drug GLP certification will be overhauled!

1.
Certificate of legal personality of the applicant institution

1.
Applicant entity qualification documents

2.
Filing certification documents of pharmaceutical research institutions

3.
Organizational Profile

2.
Organizational Summary

4.
Organizational setup and responsibilities

3.
Organizational setup and responsibilities

5.
The composition of the organization's personnel, the basic situation of the personnel and the participation in training

4.
The composition of the organization's personnel, the basic situation of the personnel and the participation in training

6.
The main personnel of the institution

5.
Situation of the main personnel of the institution

7.
Animal breeding area and animal testing area

6.
Animal feeding areas and animal testing areas

8.
Verification of calibration and analysis instruments such as inspection instruments, meters, measuring tools, scales, etc.
;

7.
Verification of instruments, meters, measuring tools, scales and other calibration and analysis instruments;

9.
List of the main instruments and equipment of the institution

8.
List of the main instruments and equipment of the institution

10.
Catalogue of Standard Operating Procedures

9.
Standard Operating Procedure Catalog

11.
Operation and management of computer systems

10.
Computer system operation and management

12.
Implementation of drug safety evaluation studies

11.
Implementation of non-clinical safety evaluation studies of drugs

13.
Previous GLP and related inspections and rectifications

12.
Previous GLP certification and GLP-related inspections

14.
Implement the self-inspection report of the "Good Management Practice for Non-clinical Research of Drugs"

13.
Implement the self-inspection report of the "Good Management Practice for Non-clinical Research of Drugs"

15.
Other relevant information

14.
Other relevant information

The name of the application materials for the 2007 version of the "Measures for the Certification of Good Management Practices for Non-clinical Research of Drugs"

The name of the application materials for the 2022 edition of the Administrative Measures for the Certification of Good Management Practices for Non-Clinical Research of Drugs (solicitation).

Application form for drug non-clinical research quality management practice certification

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Application form for drug non-clinical research quality management practice certification

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1.
Certificate of legal personality of the applicant institution

The enterprise submits a copy of the enterprise legal person registration certificate and a copy of the business license of the enterprise legal person; A copy of the registration certificate of the institution legal person submitted by the undertaking and the original or photocopy of the valid certification document issued by the competent department at a higher level; Other legally established institutions submit copies of valid certification documents issued by the competent department at a higher level or an affiliation with legal personality; All of the above institutions should submit a copy of the organization code certificate (copy
).

1.
Qualification documents of the applicant institution

The applicant institution shall submit a copy of the unified social credit code certificate, or a copy of the business license issued by the relevant registration department, or a copy of the certificate of a public institution legal person, or a copy of a valid certification document issued by the competent department at the level above
。 In addition to submitting the documents certifying the qualification of the legal entity, the institution that specifically carries out the non-clinical safety evaluation research of drugs is a branch established by a legal person or a subsidiary institution directly under it (hereinafter referred to as a branch), and in addition to submitting the documents certifying the qualification of the legal entity, it is also necessary to submit relevant materials for the establishment of the branch or the relevant documents for determining the affiliation between the legal person and the branch.

2.
Filing certification documents of pharmaceutical research institutions

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3.
Organizational Summary

(1) Overview of institutional development (including historical evolution, basic information on carrying out drug safety evaluation tests and drug safety evaluation tests according to GLP, etc.
);
(2) Organizational framework chart (indicating the name of each department, the relationship between them, the heads of each department, etc.
);
(3) Floor plan of experimental facilities (including overall floor plan and appearance photos, GLP and non-GLP area plans, laboratory and animal breeding rooms, management areas and other floor plans and the area of each region, etc.
).

2.
Organizational Summary

2.
1 Overview of institutional development (including historical evolution, the basic situation of carrying out non-clinical safety evaluation trials of drugs and non-clinical safety evaluation studies of drugs in accordance with GLP, etc.
);
2.
2 Organizational framework chart (explain the name of each department, the relationship between them, the heads of each department, etc.
);
2.
3 Floor plan of the test facility (including overall plan and appearance photo, GLP and non-GLP area plan, laboratory, animal breeding room, management area and other floor plan and the area of each area, etc.
).

4.
Organizational setup and responsibilities

Including the establishment of the institutional management department, the summary of the functions of the department such as the storage of test products, animal breeding and management, pathological examination and quality assurance

3.
Organizational setup and responsibilities

Including the establishment of the institutional management department, the summary
of the functions of the department such as the storage of test products, animal breeding and management, pathological examination and quality assurance.

5.
The composition of the organization's personnel, the basic situation of the personnel and the participation in training

See tables 1, 2 and 3

4.
The composition of the institution's personnel, the basic situation of the personnel and the participation in training

See tables 1, 2 and 3

6.
The main personnel of the institution

Including the person in charge of the institution, the person in charge of the quality assurance department, the person in charge of the topic, the person in charge of animal feeding management, the person in charge of histopathological examination department, the person in charge of data storage, the person in charge of test product management and other persons in charge) (see Table 4)

5.
The main personnel of the institution

Including the person in charge of the institution, the person in charge of the quality assurance department, the person in charge of the topic, the person in charge of animal feeding management, the person in charge of histopathological examination department, the person in charge of data storage, the person in charge of test product management and other persons in charge (see Table 4).

7.
Animal feeding area and animal testing area

(1) The area of animal facilities and the capacity of animal shelters (see Table 5);
(2) Floor plans of each animal breeding area (including animal breeding facilities, animal supplies supply facilities, experimental operation areas, sewage treatment areas, etc.
);
(3) Flow direction diagrams of people, animals, goods, sewage flow, air flow, etc.
in animal breeding areas (can be drawn in combination with floor plans), and layout plans of air supply, return air and exhaust of air purification systems;
(4) Environmental conditions, including control methods, monitoring procedures or methods for environmental conditions such as temperature, humidity, pressure difference, illuminance, noise, cleanliness, and ammonia concentration in animal breeding rooms, as well as emergency response plans in case of abnormalities; Annual inspection reports and test data of temperature, humidity, pressure gradient, microorganisms and other environmental conditions of laboratory animal facilities (see Table 6);
(5) The source and frequency of testing of animal supplies such as feed, drinking water, and litter (including feed manufacturers, nutritional analysis, analysis of harmful substances, hygiene and other test results, as well as drinking water test results, etc.
);
(6) Environmental control status of functional laboratories and special areas of chemical and biological pollution;
(vii) the use of cleaning agents, disinfectants and insecticides (see Table 7);
(8) The source, quality certificate and quarantine status of
the experimental animals.
Experimental animals used for non-clinical safety evaluation studies of drugs should indicate the specific names of the laboratory animal production licenses issued by the state and provide relevant supporting materials, and the quarantine situation shall include the recent health of the animal population and the results of pathogenic microorganism testing
.

6.
Animal feeding area and animal testing area

6.
1 Area of animal facilities and animal shelter capacity (see Table 5);
6.
2 Floor plan of each animal feeding area (including animal feeding facilities, animal supplies supply facilities, test operation areas, sewage treatment areas, etc.
);
6.
3 Flow direction diagram of people, animal flow, goods flow, sewage logistics, air flow in animal feeding area (can be drawn in combination with floor plan), air supply, return air and exhaust layout plan of air purification system;
6.
4 Environmental conditions, including control methods, monitoring procedures or methods for temperature, humidity, pressure difference, illuminance, noise, cleanliness, ammonia concentration and other environmental conditions in animal breeding rooms, as well as emergency plans in case of abnormalities; Annual inspection reports and test data of temperature, humidity, pressure gradient, microorganisms and other environmental conditions of laboratory animal facilities (see Table 6);
6.
5 Sources and testing frequency of animal supplies such as feed, drinking water, litter and other animal products (including feed manufacturers, nutritional analysis, analysis of harmful substances, hygiene and other test results, as well as drinking water test results, etc.
);
6.
6 Environmental control status of functional laboratories and special areas of chemical and biological pollution;
6.
7 Use of cleaners, disinfectants and insecticides (see Table 7);
6.
8 Source of experimental animals, quality certificate and quarantine status
.
Experimental animals used for non-clinical safety evaluation studies of drugs shall indicate the specific names of the production licenses for laboratory animals that have been uniformly issued by the state and provide relevant supporting materials, and the quarantine situation shall include the recent health of the animal population and the results of pathogenic microbial testing
.

8.
Verification of calibration and analysis instruments such as inspection instruments, meters, measuring tools, scales, etc.
;

/

7.
Verification of instruments, meters, measuring tools, scales and other calibration and analysis instruments;

/

9.
List of the main instruments and equipment of the institution

See table 8

8.
List of the main instruments and equipment of the institution

See table 8

10.
Standard Operating Procedure Catalog

Including the formulation, modification and dismantling of SOPs and SOPs

9.
Standard operating procedure catalog

Including the formulation, modification and dismantling of SOPs and SOPs
.

11.
Computer system operation and management

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10.
Computer system operation and management

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12.
Implementation of drug safety evaluation studies

(1) Implementation procedures for drug safety evaluation tests (safety evaluation test flow chart);
(2) The list describes the work of drug safety evaluation trials in the past three years (including the name of the research project carried out in accordance with GLP requirements or non-GLP conditions, the name of the subject leader, the start and end time of the trial, and the status of passing the new drug review, etc.
);
(3) The list explains the non-clinical safety evaluation of drugs carried out in accordance with GLP requirements after rectification (only the institution applying for post-rectification review is required to provide).

11.
Implementation of non-clinical safety evaluation studies of drugs

11.
1 Implementation procedures for non-clinical safety evaluation studies of drugs (flow chart);
11.
2 The table describes the implementation of non-clinical safety evaluation studies of drugs since running in accordance with GLP requirements or since the last renewal examination (see Table 9).

13.
Previous GLP and related inspections and rectifications

For institutions applying for post-rectification review, the rectification report and related materials of the problems found in the previous certification shall be included, specifying the problems found, the corrective measures taken and the rectification results
.

12.
Previous GLP certification and GLP-related inspections

It shall include the rectification report and relevant materials of the problems found in the latest inspection, specifying the problems found, the corrective measures taken and the rectification results
.

14.
Implement the self-inspection report of the "Drug Non-clinical Research Quality Management Practice"

The content of the report shall include the time of self-examination, participants, the basis of self-examination, the content of self-examination, the results of self-examination, the problems found, and the rectification situation
.

13.
Implement the self-inspection report of the "Drug Non-clinical Research Quality Management Practice"

The content of the report shall include the time of self-examination, participants, the basis of self-examination, the content of self-examination, the results of self-examination, the problems found, and the rectification situation
.

15.
Other relevant information

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14.
Other relevant information

14.
1 Those who carry out non-clinical safety evaluation studies on narcotic drugs and spiritual drugs shall establish a safety management system in accordance with relevant national regulations, and be equipped with corresponding storage conditions and safety management facilities to ensure the safety of intoxicating drugs and spiritual drugs;
14.
2 To carry out non-clinical safety evaluation studies of radioactive substances, the test facilities shall comply with the relevant national regulations and obtain radiation safety license certificates issued by the relevant administrative departments; and establish a radiation safety and protection management system in accordance with relevant national regulations, strengthen safety management, protect human health and protect the environment;
14.
3 To carry out non-clinical safety evaluation research of biohazardous substances, risk category judgment shall be carried out in accordance with relevant national regulations, and experimental research shall be conducted in laboratories of corresponding levels; And in accordance with relevant regulations, establish a biosecurity prevention and protection system, strengthen process management, protect human health, and protect the environment
.