Chapter Ⅳ-Instruments, Equipment and Experimental Supplies
Article 16 Non-clinical research organizations shall be provided with the corresponding instruments and equipment according to the study needs. The instruments and equipment shall be suitably located and managed by the authorized person. To assure the stable and reliable performance of instruments and equipment, they shall be inspected, cleaned, maintained, tested and calibrated periodically.
The Standard Operation Procedures, indicating the use, the maintenance and calibration of the instruments and equipment shall be provided in the laboratories where the equipment and instruments are placed. The date, the use and the operator's name on operating, inspecting, testing, calibrating and repairing shall be recorded in detail.
Article 17 Management of the test and control articles of non-clinical research organizations shall be in compliance with the following requirements:
1.The test and control articles of experiments shall be managed by the authorized person and shall be received, registered and distributed according to the procedures. The batch number, stability, content or concentration, purity and other chemical characteristics shall be accurately recorded. In cases where marketed products are used as control articles, such products can be characterized by their labeling or other indications to replace the laboratory analyses.
2.The test and control articles shall be stored under suitable conditions. The container storing test or control articles shall be labeled to indicate the name, abbreviation name, code number, batch number, expiry date, and storage conditions.
3.Contamination or deterioration shall be avoided during the distribution of the test and control articles. The test and control articles distributed shall be accurately labeled on time. Documentation shall be made for the date and quantity distributed and returned for each batch.
4.The uniformity of the mixture shall be determined before administration for each test or control article that is necessary to be mixed with a certain medium. The concentration and stability of the test or control article in the mixture shall also be determined periodically, if necessary. When anyone of the components of the mixture has an expiry date, the date shall be clearly shown on the container. If more than one component have expiry date, the earliest expiry date shall be taken as criterion.医.学 全在.线,提供www.med126.com
Article 18 The reagents and solutions in laboratories shall be labeled to indicate the name, concentration, storage conditions, preparation date, expiry date, etc. The deteriorated or outdated reagents or solutions shall not be used in the experiments.
Article 19 Qualified test animals and feeds shall be selected and adopted. Animal care and management shall be conducted according to the requirements of relevant national regulations concerning test animals.
Research results shall not be adversely affected by the use of detergents, disinfectants, pesticides, etc. in animal care room and the name, concentration, method used, date, etc. shall be recorded in detail.
The animal feeds and drinking water shall be periodically analyzed to ensure that they comply with the nutrition standards and that the contamination adversely affecting the research results shall be less than the limit specified. The analytical results shall be kept as raw data.
Chapter Ⅴ-Standard Operation Procedures
Article 20 Non-clinical research organizations shall establish Standard Operation Procedures suitable for all experiments as well as guidelines for editing and managing Standard Operation Procedures. Standard Operation Procedures shall include the following:
1.receipt, labeling, storage, handling, preparing, ordering, sampling and analyzing of test and control articles;
2.animal room and laboratory preparation as well as environmental monitoring and controlling;
3.maintenance, repair, calibration, use and management of experimental facilities, instruments and equipment;
4.operation and management of computer system;
5.transfer, quarantine, numbering and care of test animals;
6.observation records and experimental operations of test animals;
7.operational techniques, such as collection of test samples, examination, determination of various indexes, etc.;
8.examination and handling of animals found to be moribund or dead during study;
9.necropsy of animals as well as histopathological examination;
10. collection, numbering and examination of experimental specimens;
11. the treatment of various experimental data;
12. health examination system of personnel;
13. edition and management of Standard Operation Procedures; and
14. other Standard Operation Procedures which are considered necessary by non-clinical research organizations.
Article 21 Standard Operation Procedures shall not be valid until signed and confirmed by the Quality Assurance Unit and approved by the responsible person of research organization. Invalid Standard Operation Procedures shall be destroyed on time except one copy kept.
The establishment, revision, valid date as well as distribution and destroying of Standard Operation Procedures shall be recorded and the records shall be well maintained.
Standard Operation Procedures shall be stored in the way to assure their convenient use. Any deviations of Standard Operation Procedures shall be approved by the study director and recorded in the raw data. Any significant changes in Standard Operation Procedures shall be confirmed by Quality Assurance Unit and approved by the responsible person of research organization in written form.
Chapter Ⅵ-Study Implementation
Article 22 Non-clinical research organization shall designate a title or code number for each study project and indicate it uniformly in the documentation and experimental records concerned.
Specimens collected from experiment shall be identified by study project title or code number, animal number and collection date.
Article 23 A written protocol shall be prepared and signed by study director. The protocol shall not be implemented until reviewed by the Quality Assurance Unit and approved by the responsible person of non-clinical research organization. The approval date is defined as the initiation date of experiments. If non-clinical study project is commissioned, the protocol shall be also approved by the sponsor.
Article 24 The protocol shall contain the following:
1.title or code number of the study project and its purpose;
2.the name and address of non-clinical research organization and sponsor;
3.the name of study director and researchers engaged in the study;
4.the name, abbreviation name, code number, batch number, related physicochemical properties and biological characteristics of the test and control articles;
5.justification for selection of the test system;
6.the species, strain, number, age, sex, body weight range, source of supply and grade of the test animals;
7.the method of identification of test animals;
8.the environmental conditions for caring test animals;
9.the name and code number of the feeds;
10. solvents, emulsifiers and other media used in the studies;
11. the route, method, dosage level, frequency and duration of administration of test and control articles as well as the reason for the choice;
12. the title of guideline used in toxicity studies;
13. the frequency and method of tests, analyses and measurements;
14. statistical methods; and
15. the location where all experimental data are to be stored.
Article 25 If the protocol is necessary to be amended during the study, the amendment shall be reviewed by the Quality Assurance Unit and approved by the responsible person of research organization. The amendments, reasons and date thereof shall be recorded and kept together with the original protocol.
Article 26 Study director is responsible for the overall conduction of the study. Personnel engaged in the experiment shall carry out the protocol strictly in compliance with the corresponding Standard Operation Procedures and report on time any abnormalities found during the experiment to the study director.
Article 27 All data shall be recorded directly, accurately, legibly, indelibly and on time and shall be dated and signed by the recorder. If any record is to be corrected, the original record shall be legible and the reason for and date of the correction shall be noted, and the records shall be signed by the corrector.
Article 28 If animals display diseases caused by the factors rather than test articles or abnormalities interfering the research purpose, the animals shall be isolated and quarantined immediately. If the animals are to be treated with drugs, the treatment shall be approved by the study director, and the reasons, approval procedures, examination, drug prescription, date, result, etc. shall be recorded in detail. The treatment shall not interfere with the research.
Article 29 Study director shall prepare a final report and sign it on time after the completion of the study. The final report shall be reviewed by the Quality Assurance Unit and approved by the responsible person of the non-clinical research organization. The approval date is defined as the completion date of the study.
Article 30 The final report shall contain the following:
1.the title or code number of the study project and its purpose;
2.the name and address of non-clinical research organization and sponsor;
3.the date of initiation and completion of the study;
4.the name, abbreviation name, code number, batch number, stability, content, concentration, purity, components and other characteristics of the test and control articles;
5.the species, strain, number, age, sex, body weight range, source of supply, certificate number, certification agency, date of receipt and housing conditions of test animals;
6.the route, dosage, method, frequency and duration of administration of the test and control articles;
7.justification of dosage levels of the test and control articles;
8.the abnormalities that may have affected the reliability of the study and caused the deviation from the protocol;
9.the frequency and method of tests, analyses and measurements;
10. the names and post assignments of the study director and all researchers;
11. statistical methods;
12. study results and conclusion; and
13. the locations where all raw data and specimens are stored.
Article 31 After the final report is signed by the responsible person of non-clinical research organization, if there are corrections or additions to the final report, the parts corrected or added, the date and reasons thereof shall be explained in detail by the responsible person concerned. Such correction or additions shall be confirmed by the study director, reviewed by the Quality Assurance Unit, and approved by the responsible person of non-clinical research organization.
Chapter Ⅶ-Data and Archives
Article 32 Original protocols, specimens, raw data, records, final reports, documentation concerned with the experiment, inspection report of Quality Assurance Unit, etc. shall be ordered by the study director according to requirements of Standard Operation Procedures and handed to the archives room after completion of the study. They shall be numbered and stored according to Standard Operation Procedures.
When the study project is withdrawn or ceased, the study director shall explain the reason in written form and then put in order and keep all the data specified in articles mentioned above in the archives.
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Article 33 Archives room shall be under the charge of the authorized persons and shall be managed according to the requirements of Standard Operation Procedures.
The retention period of the protocols, specimens, raw data and documentation records, final report and other archives shall last at least 5 years since the drug marketing.
Wet specimens, the characteristics of which are liable to be changed, such as tissues, organs, electron microscopic specimens, blood smear, specimens from reproduction toxicity study, etc. shall be retained only as long as the quality of the preparation affords evaluation.
Chapter Ⅷ-Supervision, Inspection and Certification
Article 34 The State Drug Administration is responsible for supervision, inspection and certification of non-clinical research organizations.
Article 35 All non-clinical research organizations applying for drug registration in the People's Republic of China shall be regulated under the supervision, inspection and certification.
Chapter Ⅸ-Supplementary Provisions
Article 36 The State Drug Administration is responsible for explanation of the provisions.
Article 37 The provisions shall enter into force on November 1, 1999.
