SDA: Drug Good Laboratory Practices (Transitional)
SDA Regulation; Order No.14; Effective Date: 1999-11-01; Repeal Date: 2003-09-01
(Promulgated by Order No. 14 of the State Drug Administration on October 14, 1999, effective as of November 1, 1999,and abolished on September 1, 2003)
Chapter Ⅰ-General Provisions
Article 1 The provisions are established for improving the quality of non-clinical laboratory studies on new drugs, for assuring the truthfulness, integrity and reliability of experimental data, and for ensuring drug safety for human use pursuant to the stipulations of the Drug Control Law of the People's Republic of China.
Article 2 The provisions shall be adapted to non-clinical laboratory studies for applications of drug registration. All non-clinical research organizations shall follow the provisions.
Article 3 The terms used in the provisions are defined as follows:
1.Non-clinical laboratory study means any toxicity experiments performed under laboratory conditions to evaluate the safety of new drugs, including studies of single dose toxicity, repeated dose toxicity, reproduction toxicity, mutagenic action, carcinogenecity, irritation, dependence and others.
2.Non-clinical research organization means the facility which conducts non-clinical laboratory studies of new drugs, including safety research centers, safety research institutes, research laboratories or teams for safety studies, etc.
3.Test system means animals, plants, microorganisms or cells used to conduct toxicity studies.
4.Quality assurance unit means any unit in non-clinical research organizations that is designed to assure that the study is in compliance with the provisions.
5.Study director means the person who is responsible for the overall conduction of a certain study project.
6.Test article means any drug or substance to be developed into a drug used to conduct a non-clinical laboratory study.
7.Control/reference article means any drug or any other product used in non-clinical laboratory studies for the purpose of establishing a basis for comparison with the test article.
8.Raw data mean any materials and original documents or records which record the original research observations, including worksheets, notes, photographs, microfiche or microfilm copies, microcopies, computer printouts, magnetic media, recorded data from automated instruments, etc.
9.Specimen means any materials derived from a test system for analysis and examination.
10. Sponsor means the unit which commissions the non-clinical research organization to conduct the non-clinical laboratory studies for the test article.
11. Batch number means a distinctive combination of numbers and/or letters which can be used to trace and review the production history of the batch of the test or control articles.
Chapter Ⅱ-Organization and Personnel
Article 4 Non-clinical research organizations shall be in compliance with the provisions to establish a well-organized management system. It shall be staffed with a responsible person of the organization, a responsible person of the quality assurance unit and other corresponding personnel, and they shall be managed in accordance with their corresponding responsibilities.
Article 5 Personnel of non-clinical research organization shall meet the following qualifications:
1.having prudent scientific style, good professional morality and appropriate education and knowledge, receiving professional training, and possessing job experience and capabilities needed for their assignments;
2.familiarizing with the fundamentals of the provisions, strictly performing their assigned duties, skillfully mastering and strictly implementing the Standard Operation Procedures involved in the assignments;
3.making records accurately, clearly and on time, and reporting to the study director in written form on anything happening in the experiment that may adversely affect the experimental results;
4.dressing according to the needs of their work posts, conforming to requirements of personal sanitation and taking health precautions to avoid the contamination of test and control articles and test systems; and
5.taking periodical health examination. Those who are found to have an illness that may adversely affect the reliability of the study shall be excluded from the study.
Article 6 The responsible person of the non-clinical research organization shall possess a bachelor or a higher degree on medical, pharmaceutical or other relative specialities. Correspondingly professional qualification and abilities are also required. The responsibilities are as follows:
1.taking overall responsibilities and implementing the establishment and organization management of the non-clinical research organization;
2.establishing and maintaining current records of education, professional training and job experience for each individual engaged in the non-clinical laboratory studies;
3.ensuring that there are various facilities, equipment and experimental conditions in compliance with the provisions;
4.ensuring that there are an adequate number of qualified personnel with clear responsibilities and duties and that all of them carry out their work according to the requirements of the provisions;
5.designating a responsible person for the Quality Assurance Unit and ensuring that he or she completes the responsibility defined in the provisions;
6.making master schedule sheet and monitoring the progress in various studies;
7.organizing the establishment and revision of the Standard Operation Procedures and monitoring the personnel to implement the Standard Operation Procedures involved in their assignments;
8.designating a study director before the beginning of each study project. When anyone of them is to be changed, the reasons for and the date of the change shall be recorded;
9.reviewing and approving protocols and final reports;
10. timely dealing with the reports from the Quality Assurance Unit and recording in detail the measures taken;
11. ensuring that the quality and the stability of the test and control articles meet the specification; and
12. signing a written contract with the cooperator or the sponsor.
Article 7 Non-clinical research organizations shall establish an independent quality assurance unit, the number of personnel of which depends on the size of the research organization. The purpose of the establishment is to assure that the facilities, equipment and management system of the research organization are in compliance with the provisions. The responsibilities of the Quality Assurance Unit are:
1. keeping the duplicate of the master schedule sheets, protocols and final reports of the non-clinical research organization;
2. reviewing the protocols, experimental records and final reports according to the provisions;
3. inspecting and supervising every study project and making a plan for reviewing and inspection based on the study project and its duration. Recording in detail inspection, problems existing and measures taken, signing the name and keeping the records for reviewing;
4. inspecting periodically the animal care facilities, experimental instruments and the management of the archives;
5. reporting the problems found during the inspection to the responsible person of the organization and the study director on time, proposing suggestions for solving them and writing down an inspection report; and
6. taking part in the establishment of Standard Operation Procedures and keeping a duplicate of the Standard Operation Procedures.
Article 8 A study director shall be designated in each study project, whose responsibilities are as follows:
1. taking whole responsibilities of the routine operations of the study project;
2. preparing the protocols, proposing the revision or addition of the corresponding Standard Operation Procedures, analyzing the study results and drafting the final reports;
3. complying strictly with the protocols. Any changes shall be approved by the responsible person of the organization;
4.assuring that the personnel engaged in the study understand clearly the assignments undertaken and have a good command of the corresponding Standard Operation Procedures;
5.monitoring the progress of the study project and inspecting the various experimental records to assure them to be accurate, direct, clear, and on time;
6.recording in detail the unforeseen cases during the experiment and the measurements taken for remedy;
7.sending the protocols, raw data, specimens which shall be kept, corresponding documentation records and final reports to the archives room after the completion of the experiment; and
8.assuring that each step of the study project is in compliance with the requirements of the provisions.
Chapter Ⅲ-Laboratory Facilities
Article 9 Non-clinical research organizations shall establish corresponding experimental facilities in accordance with the requirements of the provisions and the study project.
All kinds of laboratory facilities shall be kept clean and sanitary, and laid out in a rational way to avoid cross contamination. The environmental conditions shall be monitored as needed.
Article 10 Non-clinical research organizations shall have animal care facilities designed rationally and allocated suitably. The environmental conditions, including temperature, humidity, air cleanness, ventilation, lighting, etc. shall be controlled according to the needs. Animal care facilities mainly include the following:
1.the animal care and management facilities for different genus and species of animals or test systems;
2.the facilities for quarantine of animals and for isolation and treatment of diseased animals;
3.the facilities for collection and disposal of wastes;
4.the facilities for cleaning and disinfection; and
5.the corresponding animal care and management facilities that shall be established when test or control articles contain volatile substance, radioactive materials, biohazardous materials, etc.
Article 11 Non-clinical research organizations shall have storage facilities for feeds, bedding materials, cages and other articles for animal use. Allocation of various facilities shall be rational, preventing contamination with test system. Proper measures shall be taken for easily decayed and deteriorated articles for animal use.
Article 12 Non-clinical research organizations shall have the facilities for handling test and control articles:
1.facilities for receipt and storage of the test and control articles; and
2.facilities for preparing and storing test and control articles.
Article 13 Non-clinical research organizations shall establish corresponding laboratories in accordance with the needs. Specialized laboratories shall be established if biohazardous materials, microorganisms, etc. are handled and used.
Article 14 Non-clinical research organizations shall have facilities for storing protocols, specimens, raw data, final reports, relative documentation and records.
Article 15 Non-clinical research organizations shall establish facilities for environmental monitoring and control.
