Chapter 1 General Principles

1 to ensure the quality of the evaluation of the non -clinical safety of drugs，Safety safety for public medication，According to the "Regulations on the Implementation of the People's Republic of China Drug Administration Law" and "The People's Republic of China Pharmaceutical Management Law"，Develop this specification。

Article 2 This specification is applicable to the non -clinical safety evaluation research for drug registration for drug registration。Related activities for the evaluation of non -clinical safety evaluation of drugs shall abide by this specification。Other drugs for the purpose of registered clinical related research activities shall be implemented with reference to this specification。

Article 3 Non -clinical safety evaluation research is the basic work of drug development，It should be ensured that behavior specifications，Data Real、Accurate、Full。

Chapter 2 The term and its definition

Article 4 The meaning of the following terms in this specification is:
(1) Non -clinical research quality management specifications，Refers to the design of the operating management and non -clinical safety evaluation research project of non -clinical safety evaluation research institutions、Organization Implementation、execution、Check、Record、Quality management requirements for the entire process of archive and report。
(2) Research on non -clinical safety evaluation，Refers to evaluating drug safety，Tests performed by experimental system under laboratory conditions，Including safety pharmaceutical test、Single -dosing toxicity test、Repeated drug toxic test、Reproductive toxicity test、Genetic toxicity test、Carcinogenic test、Local toxic test、Immunosity test、Dependence test、Poison Dynamic Test and other tests related to evaluation of drug safety。
(3) Non -clinical safety evaluation research institutions (hereinafter referred to as research institutions)，Refers to those who have the research on non -clinical safety evaluation、Facilities, equipment and quality management systems and other conditions，Units engaged in non -clinical safety evaluation in drugs。
(4) Research on multiple places，Refers to the research projects completed in different places in different research institutions or in different research institutions。There is only one test plan for this type of research project、Special person in charge，Form a summary report，The person in charge of the special topic and the research institution or place of the experimental system is "main research venue"，Other research institutions or places responsible for implementing research work are "sub -research venues"。
(5) The person in charge of the institution，refers to personnel who are responsible for the organization and operation management of a research institution in accordance with the requirements of this specification。
(6) Special person in charge，Refers to personnel who are fully responsible for organizing the implementation of a person in a test in a non -clinical safety evaluation research。
(7) Main researcher，Refers to research in multiple places，Representative person in charge of the person in charge of the person who implemented the test at the sub -research venue。
(8) The commissioner，Refers to the unit or individual of the entrusted research institution to conduct non -clinical safety evaluation research。
(9) Quality Assurance Department，Refers to departments that perform the quality assurance function of non -clinical safety evaluation research work，Responsible for each study and related facilities、Equipment、Personnel、Method、Operation and records for inspection，To ensure that the research work meets the requirements of this specification。
(10) Standard operating regulations，Refers to the programmatic file describing the operation management and test operation of the research institution。
(11) Main Plan Form，Refers to the information summary of helping to master the workload and tracking the research process in the research institution。
(12) Testing scheme，Refers to the document described in detail and the design of the test design，Including its change file。
(Thirteen) The test plan is changed，refers to after the test plan is approved，Modification of the content of the test plan。
(14) Disting，Refers to the situation that does not meet the test scheme or standard operating regulations caused by non -intentional or foreseeable factors。
(15) Experimental system，Refers to animals used in non -clinical safety evaluation research、Plants、microorganisms and organs、Organization、Cell、Gene, etc.。
(16) Test/test product，Refers to substances for safety evaluation through non -clinical research。
(17) Control products，Refers to compare substances compared with the subject。
(18) Solid media，refers to mix、Diversion or dissolved test objects、control products，so as to give it a media material to the experimental system。
(19) batch number，Refers to a set of numbers or letters plus numbers used to identify "batch"，to ensure the traceability of the test or control products。
(20) Original data，Refers to，The original records of the research work and related documents or materials，or a verified copy，Including work records、Various photos、Minimal film、Computer printing information、Magnetic carrier、Data recorded by the instrument and equipment。
(21) Specimen，refers to the experimental system，Used for analysis、Measured or saved materials。
(22) Study start date，Refers to the date of signing and approval test plan for the person in charge of the person in charge。
(23) Study completion date，Refers to the date of signing and approval report on the person in charge of the topic。
(24) Computerization system，refers to a set of hardware and software controlled by computer，Common one or a set of specific functions。
(25) Verification，Refers to the activity that proves that a process can continue to meet the expected purpose and quality attribute。
(26) Electronic data，Refers to any text expressed in electronic form、Chart、Data、Sound、Image and other information，Complete its establishment from the computerized system、Modify、Backup、Maintenance、Archive、Search or distribution。
(27) Electronic signature，refers to a set of computer code for the signature of handwriting，It has the same legal effect as the signature of the handwritten。
(28) Inspection trajectory，Refers to continuous records of system activities in the order of time，This record is sufficient to rebuild、Review、The process of checking the system activity，In order to master the changes in activities and operating environment that may affect the final result。
(29th) peer review，refers to a review program used to ensure the quality of the data，Evaluation of the research plan or results of the researchers from other experts and scholars in the same field。

Chapter III Organizations and Persons

5 Research institutions shall establish a sound organizational management system，The person in charge of the equipment institution、Quality Guarantee Department and Corresponding Staff。

Article 6 The staff of the research institutions shall meet at least the following requirements:
(1) I have received educational or professional training related to their work，Has the knowledge required by the work、Work experience and business ability;
(2) Master the requirements related to work in this specification，and strictly execute;
(3) Strict implementation of standard operating rules related to the work assumed，The situation of deviating standard operating procedures occurred in the study should be recorded in a timely manner and reports to the person in charge or main researcher in writing;
(4) Strictly implement the requirements of the test plan，Timely、Accurate、Clearly record the original data，and be responsible for the quality of the original data，The situation of the deviation test scheme in the study should be recorded in a timely manner and reports to the person in charge or main researcher in writing;
(5) Take the necessary protection measures according to the needs My stake betting appof the job，minimize the safety risk of staff，Make sure that the test is at the same time、The control product and the experimental system are not chemical、Biological or radioactive pollution;
(6) Regular physical examination，When a health problem occurs，To ensure the quality of research，Should avoid participating in the work that may affect research。

Article 7 The person in charge of the institution is fully responsible for the operation management of the research institution，At least the following responsibilities should be fulfilled:
(1) Ensure that the operation management of the research institution meets the requirements of this specification;
(2) Ensure that the research institution has sufficient quantity、L qualified persons，and facilities that meet the requirements of this specification、Instrument equipment and materials，To ensure the timely research project、Run normally;
(3) Make sure the educational background of the establishment of staff、Work experience、Training situation、Job description and other information，Update in time;、Update in time;
(4) Ensure that the staff clearly understands their duties and the content they take.，If necessary, it should provide training related to these work;
(5) Make sure to establish appropriate、Standard operating procedures that meet the technical requirements，and ensure that the staff strictly abide by the standard operation regulations，All newly -built and modified standard operating procedures must be signed and approved by the person in charge of the institution to take effect，The original files are saved as a file;
(6) Make sure to formulate a quality assurance plan in the research institution，Execute by independent quality assurance personnel，and ensure that it performs quality assurance responsibilities in accordance with the requirements of this specification;
(7) Make sure to formulate the main plan form and update it in time，Make sure that regularly archive the main plan table for saving，The main plan form should include at least the research name or code、The name of the test object or code、Experimental System、Research Type、Starting time of research、Research Status、Name of the person in charge of the topic、Entrustge，Involved in multiple places research，It should also include the information of the sub -research venue and the information of the main researcher，in order to master the progress of all non -clinical security evaluation research work and resource allocation in the research institution;
(8) Make sure to specify an appropriate qualification for each test before the research starts、The person in charge of experience and training experience，The replacement of the person in charge of the topic shall be carried out in accordance with the prescribed procedures and records;
(9) The person in charge of the institution of the sub -research venue，In the case of many places research，It should be specified that one with appropriate qualifications、The main researchers of experience and training experience are responsible for the corresponding test work，The replacement of the main researchers shall be carried out in accordance with the prescribed procedures and records;
(10) Ensure that the report of the quality assurance department is dealt with timely，and take necessary corrective、Preventive measures;
(11) Make sure the test、The control product has the necessary quality characteristics information，and designate a special person to be responsible for the test、Management of control products;
(12) Designate a special person responsible for the management of the file;
(13) Ensure that the computerized system is suitable for its purpose，and verify in accordance with the requirements of this specification、Use and maintain;
(14) Ensure that research institutions participate in the necessary testing laboratory capacity verification and comparison activities according to the needs of research;
(15) Signed a written contract with the commissioner，Clarify the duties of all parties;
(16) In many places research，The person in charge of the institution of the sub -research site，Should fulfill all responsibilities other than the requirements of the above (8th),。

Article 8 Research institutions shall establish an independent quality guarantee department responsible for checking the implementation of this specification，To ensure that the operation management of research meets the requirements of this specification。
The responsibilities of quality assurance personnel should be at least included in the following aspects:
(1) Preservation of a copy of the trial scheme and test solution modified by the research on the implementation、A copy of the current standard operating regulations，and get a copy of the Lord's plan form in time;
(2) The review test plan meets the requirements of this specification，The review should be recorded and archived;
(3) Formulate inspection plans based on the content and duration of the research，Examination of each study，To confirm that all studies are carried out in accordance with the requirements of this specification，and record the contents of the inspection、The problem found、Suggestions made;
(4) Regularly check the operation management status of the research institution，To confirm the work of the research institution in accordance with the requirements of this specification;
(5) Any problems found in the inspection、The suggestions made should be tracked and inspected and verified the rectification results;
(6) Report the results of the inspection results to the person in charge of the institution or the person in charge in writing，Research on multiple places，Quality Guarantee personnel of the research venue need to report the inspection results to the main researcher and person in charge of the research institution，and the person in charge of the institution of the main research venue、The person in charge and quality assurance personnel of the topic;
(7) Review Summary Report，Sign quality assurance statement，Clear the content of the check and check time，and the results of the inspection results to the person in charge of the institution、Special person in charge、Date of main researchers (under multiple places)，To confirm its accurate and complete description of the research method、Program、Results，The original data of the study truly reflects the research;
(8) All the current standard operation regulations in the review and research institution，Participate in the formulation and modification of the standard operation regulations。

1 The person in charge of the special topic is responsible for the implementation and summary report of the research，Its responsibilities should be at least included:
(1) Approve the test plan and the test solution of the name and date of signing name and date，and ensure the quality assurance personnel、Test personnel obtain a copy of the test plan and test solution change in time;
(2) Proposed amendments in time、Suggestions related to the standard operation regulations for supplementary standards;
(3) Make sure that the test personnel understand the test solution and test solution change、Master the content of the corresponding standard operating procedures，and abide by its requirements，Ensure that any deviation test plan or standard operating regulations occurred in the study，Evaluate the effects of these situations on the quality and integrity of the research data，Correct measures should be taken if necessary;
(4) Master the progress of research，Make sure timely、Accurate、Record the original data completely;
(V) Timely processing quality assurance department issues，Ensure that the research work meets the requirements of this specification;
(6) Make sure the instrument and equipment used in the study、Computerization system is confirmed or verified，and in a applicable state;
(7) Make sure that the test system is given to the experimental system、The control preparation is fully tested，To ensure its stability、concentration or uniformity meets the research requirements;
(8) Make sure the summary report is true、Completely reflected the original data，Signed the name and date in the summary report to be approved;
(9) Make sure the test plan、Summary report、Original data、specimen、All research materials related to the samples of the test objects or control products are fully archived and stored;
(10) In many places research，Ensure that the test plan and summary report clearly states that the main researcher involved in the institute、Main research venue、The tasks assumed separately in the place of research;
(11) Study in multiple places，Make sure that the trial work assumed by the main researchers meets the requirements of this specification。

Chapter 4 Facilities

Article 10 Research institutions shall establish corresponding facilities in accordance with the needs of non -clinical safety evaluations they are engaged in，and ensure that the environmental conditions of the facility meet the needs of the work。Various facilities should be reasonable、Normal operation，and have the necessary function division and intervals，Effectively avoid interference that may be caused by research。

Article 11 has an animal facilities that can meet the needs of research，and can regulate the temperature as needed、humidity、Air stake sports betting appcleanliness、Economic conditions such as ventilation and lighting。The conditions for animal facilities should be consistent with the experimental animal level used，Its layout should be reasonable，Avoid the experimental system、Test、Pollution between waste。
Animal facilities should meet the following requirements:
(1) Different species of experimental animals can be effectively isolated;
(2) Experimental animals with different research should be able to get effective isolation，Prevent different tests、Cross interference between the control products;
(3) The quarantine of experimental animals and the isolation of experimental animals、Treatment facilities;
(4) When the subject or the control product contains volatility、Radioxuality or biological hazardity and other substances，Research institutions shall provide a separate research for this study、Effective isolation animal facilities，to avoid adverse effects on other research;
(5) With cleaning and disinfection facilities;
(6) With feed、Cushion、Storage facilities for cage and other experimental supplies，Products that are easy to corrupt and deteriorate should have appropriate custody measures。

Article 12 of the facilities related to test materials and control products shall meet the following requirements:
(1) Acceptance of the test objects and control products、Keep、Independent room or area for preparation storage after preparation and formulation，and take the necessary isolation measures，To avoid cross -pollution or confusion of the test objects and control products，Related facilities should meet different test objects、The control product is for storage temperature、humidity、Requirements for environmental conditions such as light，to ensure that the subjects and control products remain stable within the validity period;
(2) The storage area of ​​the subject and the controlling and its preparations should be effectively isolated，To prevent it from adversely affecting research;
(3) The storage area of ​​the subjects and control products and their preparations should be necessary safety measures，to ensure the safety of the test objects and control products and their preparations during storage and storage。

Article 13 The facilities for archives storage shall meet the following requirements:
(1) Prevent unauthorized personnel from contacting files;
(II) Computer -based archive facilities have safety measures such as preventing unauthorized access and virus protection;
(3) It is necessary to be equipped with the necessary equipment according to the requirements of the storage conditions of the file，Effectively control the fire、Water、worm、Rat、Electricity interruption and other harmful factors;
(4) For archives storage facilities with specific environmental conditions，Perform sufficient monitoring。

Article 14 Research institutions shall have facilities that collect and dispose of experimental waste; for waste disposal in the research institution，It should have the conditions for temporary or transfer。

Chapter 5 Instrument Equipment and Experimental Materials

Article 15 The research institution shall be equipped with the corresponding instrument and equipment according to the needs of the research work，Its performance should meet the purpose of use，Reasonable place for placement，Clean regularly、Maintenance、Test、Calibration、Confirmation or verification, etc.，To ensure that its performance meets the requirements。

Article 16 It is used for data collection、Transmission、Storage、Treatment、Archives, etc. The computerized system (or equipment containing computer systems) shall be verified。The electronic data generated by the computerized system should have a complete inspection trajectory and electronic signature，To ensure the integrity and effectiveness of the data。

Article 17 For instrument and equipment，There should be standard operating procedures in detail to explain the use and management requirements of each instrument and equipment，The use of instrument and equipment、Clean、Maintenance、Test、Calibration、Confirmation or verification and maintenance shall be recorded in detail and archived。

Article 18 The use and management of tests and control products shall meet the following requirements:
(1) Testing objects and control products should be kept for special custody，There is a complete reception、Registration and distribution procedures，The batch number of each batch of tests and control products、Stability、content or concentration、Pure and other physical and chemical properties should be recorded，When the controlling product is commercially available products，It can use its label or instructions;
(2) The storage and storage conditions of the test objects and control products shall meet its specific requirements，The stored container is storage、distribution、Tags should be labeled when used，indicate the name of the product、Abbreviation name、Code or Chemical Digestation Number (CAS)、Batch number、concentration or content、Effective period and storage conditions and other information;
(3) During the distribution process of test objects and control products，Record distribution、The date and quantity of the return;
(4) When the subjects and control products need to mix with the solution，Stability analysis should be performed，Make sure that the subject and control products are in a stable state，and regularly determine the concentration of subjects and control products in the mixture preparation、Native sex;
(5) Test duration of more than surrounding research，The test and control products of each batch number used should be left enough for a sample，The need for re -analysis，And after the research is completed, it is preserved as a file。

Article 19 The reagents and solutions of the laboratory shall be labeled，indicate the name of the product、Concentration、Storage conditions、Preparation date and validity period, etc.。Do not use spoiled or expired reagents and solutions in the study。

Chapter 6 Experimental System

Article 20 The management of experimental animals shall meet the following requirements:
(1) The use of experimental animals should pay attention to animal welfare，Follow "Reduction、Replacement and Optimization "principle，Test plan shall be approved by the Animal Ethics Committee before the implementation of the test plan。
(2) Detailed record of the source of experimental animals、Arrival date、Quantity、Health status and other information; newly entered facilities should be isolated and quarantine，To confirm that its health meets the requirements of the research; during the research process, experimental animals are ill,，It should be given timely、Treatment of treatment，Diagnosis、Corresponding measures such as treatment shall be recorded。
(3) Experimental animals give the subject for the first time、Before the control product，There should be enough time to adapt to the test environment。
(4) Experimental animals should have appropriate individual recognition logo，To avoid confusion when different individuals of experimental animals are moved out or moved in。
(5) The environment and related tools of experimental animals should be cleaned regularly、Disinfection to maintain hygiene。Moisturizer used in the animal breeding room、disinfection agent and pesticides，Do not affect the test results，should be recorded in detail its name、Concentration、How to use and time of use。
(6) Feed of experimental animals、pads and drinking water should be tested regularly，Make sure it meets the standards of nutrition or pollution control，The results of its test should be saved as the original data archive。

Article 21 The source of experimental systems other than experimental animals、Quantity (volume)、Quality attribute、Receiving date, etc. shall be recorded in detail，and save and use it under the right environmental conditions; the applicability assessment should be carried out before use，If there is a quality problem。

Chapter 7 Standard Operation Regulations

Article 22 The research institutions shall formulate standard operating procedures that are compatible with their business，to ensure the reliability of the data。Publicly published textbooks、Literature、Technical information set by the user manual formulated by the manufacturer can be used as a supplementary instructions for standard operating procedures for use。Standard operating procedures that need to be developed usually include but not limited to the following aspects:
(1) The formulation of standard operation rules、Amendment and management;
(2) Quality guarantee procedure;
(3) Receiving of the test objects and control products、Identification、Save、Treatment、Preparation、Received and sampling analysis;
(4) Preparation of animal rooms and laboratory and environmental factors;
(5) Maintenance of experimental facilities and instrument equipment、Maintenance、stake betting appCorrect、Use and manage, etc.;
(6) The security of the computerized system、Verification、Use、Management、Change control and backup;
(7) Receive of experimental animals、Quarantine、Number and breeding management;
(8) Observation records and test operations of experimental animals;
(9) Collection of various test samples、Checking and determination of various indicators and other operating technologies;
(Ten) Examination of Distan or Death Experimental Animals、Treatment;
(11) Anatomy of experimental animals、Tested pathological examination;
(twelve) collection, number and inspection of specimens;
(13) Management and processing of various test data;
(14) The health management system of staff;
(15) Treatment of experimental animal corpses and other waste。

Article 23 Standard Operation Regulations and its revised version shall be reviewed by quality guarantee personnel、The person in charge of the institution is approved to take effect before it can take effect。Standard operating procedures for failure except for their original file archives，The remaining copies should be destroyed in time。

Article 24 The formulation of standard operating procedures、Amendment、Approval、Effective date and distribution、Destruction should be recorded and archived for saving。

Article 25 The distribution and storage of standard operating procedures shall ensure that the staff is convenient for staff。

Chapter 8 The Implementation of Research Work

Article 26 Each test shall have a name or code，and use the name or code in the research related documents and test records。Various samples collected in the experiment shall indicate the name or code、Sample number and collection date。

Article 27 Before the start of each study，A test plan should be drafted，The quality assurance department reviews the situation that it meets the requirements of this specification and is approved by the person in charge of the topic.，The date approved by the person in charge of the topic is used as the start date of the research。Research on entrustment，The test plan shall be recognized by the commissioner。

Article 28 Display the test plan when the test plan needs to be modified，and after the quality assurance department review，Approve the person in charge of the topic。The change of the test plan should include the content of the change、Reasons and Date，Save with the original test plan。Research was canceled or terminated，The change of the test plan should explain the reason for cancellation or termination and ending method。

The main content of the test scheme of 29 should include:
(1) Research name or code, research purpose;
(2) The names of all research institutions and commissioners participating in research、address and contact information;
(3) The person in charge of the topic and the name of the main staff participating in the test，In the case of research on multiple places, it should be clearly responsible for research places for trial work in various parts、Main researchers' names and the work they undertaken;
(4) Test standards based on the research institute、Technical Guide or Literature, as well as the quality management specifications of non -clinical research obeyed;
(5) The name of the subject and control products、Abbreviation name、Code、Batch number、Stability、concentration or content、purity、Activities and other related physical and chemical properties and biological characteristics;
(6) Research soluble media、Name of Emulsion and other media、Batch number、Related nature or biological characteristics;
(7) Experimental system and reasons for choice;
(8) The species of the experimental system、Series、Quantity、Age、Gender、Weight range、Source、Level and other related information;
​​(9) The identification method of the experimental system;
(10) The environmental conditions of the test;
(11) Feed、Cushion、Name or code of drinking water, etc.、Source、batch number and main control indicators;
(12) Drug governance of test objects and control products、Method、Dose、frequency and reasons for choice and the reasons for choice;
(13) Detection methods and frequency of various indicators;
(14) Data statistical processing method;
(Fifteenth) Preservation location.

Article 30 Students participating in the research shall strictly implement the test plan and the corresponding standard operating regulations，All data generated by the record test，and timely、Direct、Accurate、Clear and difficult to eliminate，You need to indicate the record date、Recorder signature。The data of the record needs to be modified，It should be kept clear and distinguished，and indicate the reasons for modifying and the date of modification、Signature of the modified person。Generation of electronic data、Modification should meet the above requirements。
Any departure test plan and standard operating regulations occurred during the research process，All should be recorded and reported to the person in charge of the topic，In the case of multiple places research。Special person in charge or main researcher should evaluate the effects of the reliability of research data，Correct measures when necessary。

Article 31 During the evaluation of pathological peers，Plan for peer review、Management、Records and reports should meet the following requirements:
(1) The evaluation work of the pathology peers should be described in detail in the test plan or the test plan;
(2) The process of the evaluation of the pathology colleagues，and the specimen and files of the review should be recorded in detail and traceable;
(3) Develop a processing procedure when the opinions of the pathologist and the subject pathologists of peers;
(4) The results after the review after the peer and the diagnostic results of the subject pathologists，It should be discussed in the summary report;
(5) After the peer evaluation is completed, a peer evaluated pathologists issued a peer evaluation statement and signed the date of indication;
(6) The summary report shall indicate the name of the pathologist for the pathologist at the peers、Qualifications and units。

Article 32 All studies shall have a summary report。The summary report shall be reviewed by the quality guarantee department，Finally signed and approved by the person in charge of the topic，Approval Date as the date of the study。Research was canceled or terminated，The person in charge of the topic should write a brief test report。

Article 33 The main content of the summary report shall include:
(1) Research name, code and research purpose;
(2) The names of all research institutions and commissioners participating in research、address and contact information;
(3) Test standards based on the research institute、Technical Guide or Literature, as well as the quality management specifications of non -clinical research obeyed;
(4) Study start and ending date;
(5) Special person in charge、Main researchers and the names of the main personnel who participated in the work and the work content of the work;
(6) The name of the subject and control products、Abbreviation name、Code、Batch number、Stability、content、Concentration、purity、Components and other quality characteristics、Analysis of the test objects and control products，Research soluble media、Name of Emulsion and other media、Batch number、Related nature or biological characteristics;
(7) The species of the experimental system、Series、Quantity、Age、Gender、Weight range、Source、Experimental animal qualification certificate number、Received date and breeding conditions;
(8) Drawing path for subjects and control products、Dose、Method、frequency and dating period;
(9) The dose design basis for subjects and control products;
(10) Detection methods and frequency of various indicators;
(11) Analyze the statistical method used in data;
(12) Results and conclusions;
(Thirteen) The preservation location of the file;
(14) All affect this specification in compliance、Research data reliability;
(15) Quality Assurance Department's Quality Assurance Statement signed by the department;
(Sixte 16) Signed by the person in charge of the special topic、Statement Study that conforms to this specification statement;
(17) In the case of multiple places,，It should also include the name of the main researcher signed the name、Date of the relevant test part of the test part。

Article 34 The summary report is approved，When you need to modify or supplement，It should be modified or supplemented in the form of a revised file，Detailed explanation of modified or supplementary content、Reason，and after the quality assurance department review，Approve the name and date signed by the person in charge of the topic。In order to meet the requirements of the registration requirements, the situation of the summary report format does not belong to the revision of the summary report。

Chapter 9 Quality Assurance

35 Research institutions shall ensure the independence of quality assurance work。Quality Guarantee personnel cannot participate in the implementation of specific research，or assume other tasks that may affect its quality assurance work。

Article 36 The Quality Assurance Department shall formulate a written quality guarantee plan，and specify the executive，To ensure that the research work of the research institution meets the requirements of this specification。

Article 37 The Quality Assurance Department shall formulate a corresponding standard operating regulations for quality assurance activities，Including the operation of the quality assurance department、The My stake betting appformulation of quality assurance plan and inspection plan、Implementation、Records and reports，Archives and preservation of related information。

Article 38 Quality Guarantee Inspection can be divided into three types of inspection types:
(1) Research -based inspection，This type of inspection is generally performed based on the progress and critical stage of specific research projects;
(2) Facilities -based inspection，This type of inspection is generally based on a general facilities and activities based on a research institution (installation、Support Service、Computer system、Training、Environmental monitoring、Maintenance and calibration, etc.);
(3) Process -based inspection，This type of inspection is generally not based on specific research projects，but based on a program or process with a duplicate nature。
Quality guarantee inspection should have process records and reports，If necessary, it should be provided to the regulatory department for inspection。

Article 39 The Quality Assurance Department shall review and issue a quality assurance statement on all research projects implemented in accordance with this specification。Quality Guarantee Statement should contain a complete research identification information、Related quality assurance inspection activities and the date and stage of the report。Any modification or supplement to the complete summary report shall be re -reviewed and signed the quality assurance statement。

Article 40 Quality Guarantee personnel Before signing the quality assurance statement，It should be confirmed that the test meets the requirements of this specification，Follow the test scheme and standard operation regulations，Confirmation summary report is accurate、Reliable to reflect the original data。

Chapter 10 Data File

Article 41 The person in charge of the topic shall ensure that all information is studied，Including the original of the test scheme、Original data、specimen、Related test report、Store samples and control products、The original report of the summary report and various documents related to the relevant documents，Archive in time during the research and implementation process or after the research is completed，The longest does not exceed two weeks，After finishing the requirements of the standard operating regulations，Save as a research file。

Article 42 Studies are canceled or terminated，The person in charge of the topic shall preserve the above research data as research files。

Article 43 Other information that does not belong to the scope of research files，Including all inspection records and reports of the quality assurance department、Main Plan Form、Education background of staff、Work experience、Training situation、Mascher qualification、Data described by the post、Related information about the instrument and equipment and computerization system、Personnel organizational structure documents of the research institution、History files of all standard operating procedures、Environmental condition monitoring data, etc.，Should be paid regularly。The specific archive time limit should be performed in the standard operating regulations、Responsible personnel put forward clear requirements。

Article 44 Files shall be managed by a special person designated by the person in charge of the institution in accordance with the requirements of the standard operating regulations，and be responsible for its integrity，At the same time, archives should be established to facilitate retrieval。Persons who enter the archives facilities need to be authorized。Put or take out the materials in the file facilities shall be accurately recorded。

Article 45 The preservation period of the file shall meet the following requirements:
(1) Study for registered application materials，The storage period of its archives should be at least five years after the drug is listed;
(2) Research on the application materials for registration (such as termination of research)，The storage period of its file is at least five years in the summary report;
(3) Other materials that do not belong to the field of research files should be stored at least ten years after it is generated。

Article 46: When the archives are storage,，The necessary processing of the file can be adopted to be destroyed，The treatment measures and processes taken should be carried out in accordance with the standard operating regulations，and there are accurate records。Under possible circumstances，The processing of the research file shall be approved by the commissioner。

Article 47 For files that are easy to change in quality，such as tissue organs、Electronics specimen、Blood painting、Sample samples of test objects and control products，It should be able to perform effective evaluation as the preservation period。For electronic data，Standard operating procedures for data backup and recovery should be established，to ensure its safety、Integration and readability，The storage period shall meet the requirements of Article 45 of this specification。

Article 48 Research institutions no longer perform the requirements of this specification for reasons for suspension、When there is no legal successor，The archives they keep should be transferred to the archives facilities of the client or in the archive facilities specified by the client，until the final storage period of the file。File facilities that receive transfer files shall strictly implement the requirements of this specification，Effectively managed the files it received and accepted the supervision of the regulatory authorities。

Chapter 11 The Entrusted Party

Article 49 The commissioner as the sponsor of the research work and the applicant of the research results，Responsible for the research data for registration for registration，and bear the following responsibilities:
(1) Understand the requirements of this specification，Especially the person in charge of the organization、Special person in charge、The responsibilities requirements of the main researcher;
(2) Before the entrustment of non -clinical safety evaluation research，Evaluate the research institution through inspection and other methods，To confirm that it can observe the requirements of this specification, research;
(3) Before the start of the study，The test plan shall be recognized by the client;
(4) Inform the research institution's related security information of the subjects and control products，To ensure that the research institution takes the necessary protection measures，Avoid the potential risks of personal health and environmental safety;
(5) The work of testing the characteristics of the subject and control products can be detected by the commissioner、The research institution or laboratory entrusted by its commission is completed，The client should ensure that the test it provides、The characteristic information of the control product is true、Accurate;
(6) Ensure that research is implemented in accordance with the requirements of this specification.

Chapter 12 Attachment

Article 50 This specification will be implemented from September 1, 2017，"Specifications for Quality Management Quality Management of Drugs" released on August 6, 2003 (Order No. 2 of the State Food and Drug Administration)。