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Standard to be satisfied by test facilities, etc. conducting toxicity investigation

Chapter 4  Standard Operating Procedures, Etc. (Article 10 - Article 12)

In Japanese

(Standard operating procedures)
Article 10  The following shall be included in the standard operating procedure:

1) Matters related to receipt, storage, and handling of the test substance and control substance.

2) Matters related to operation, inspection, and maintenance of the equipment.

3) Matters related to handling of the test system.

4) Matters related to care and management of experimental animals.

5) Matters related to preparation, storage, and identification of reagents.

6) Matters related to observation, measurement, inspection, and analysis.

7) Matters related to data handling, storage, and retrieval.

8) Matters related to confirmation of performance of the computer system.

9) Matters related to safety and health.

10) Matters related to wastes disposal.

11) Matters necessary for execution of the study in addition to those mentioned in each of the preceding items.
2 The standard operating procedures shall be made available in each area where the study related to the standard operating procedures is implemented.

(Study Protocol)
Article 11  The study protocol shall be prepared for each study before starting the study concerned.
2 The following shall be included in the study protocol:

1) Title and purpose of the study

2) Name and address of the test facility, etc.

3) Name and address of the sponsor for studies performed under contact

4) Name and post of the study director

5) Date scheduled to start the study and the study period

6) Name, purity, composition, and physicochemical properties of the test substance and the control substance

7) Test methods adopted

8) Environmental conditions of the test system

9) Observation, measurement, inspection, and analysis methods and frequency

10) Solvent or emulsifier used for dissolving or suspending the test and control substances (if the test substance is gas, the gas used for diluting)

11) Statistical technique used for data analysis

12) Method for storing records, samples, and materials

13) Matters necessary for implementing the study in addition to those mentioned in each of the preceding items

(Quality Assurance Program)
Article 12  The matters to be stated in the quality assurance program shall include the following:

1) Matters related to the study audit and inspection.

2) Matters related to the inspection of facilities for implementing the study.

3) Matters related to the audit of the final report.

4) Matters necessary for implementing duties related to quality assurance in addition to those mentioned in each of the preceding items

Chapter 1 / Chapter 2 / Chapter 3 / Chapter 4 / Chapter 5 / Chapter 6 / Chapter 7