JICOSH Home | Guidelines | Guidelines for Certification of Compliance with Industrial Safety and Health Law GLP concerning Test Facilities, etc. Appendix

JICOSH was closed in 2008. For further information, please contact JISHA.

JICOSH Home > Guidelines > Guidelines for Certification of Compliance with Industrial Safety and Health Law GLP concerning Test Facilities, etc. Appendix

Guidelines for Certification of Compliance with
Industrial Safety and Health Law GLP concerning Test Facilities, etc.
In Japanese

Appendix

Guidelines for Inspection on Industrial Safety and Health Law GLP

  The inspection prescribed in No. 3-2 of Guidelines for Certification of Compliance with Industrial Safety and Health Law GLP concerning Test Facilities, Etc. and other evaluations on the results, etc. shall conform to the provisions set forth below.

1  Conduct of Inspection

  Director-General of Labour Standards Bureau, Ministry of Health, Labour, and Welfare shall carry out inspection on the relevant test facilities, etc. whenever it is deemed necessary to carry out certification of compliance.

2   Personnel in Charge of Inspection

  Inspection shall, in principle, be carried out by an inspection team comprising the personnel in charge of labour standard of MHLW and personnel of National Institute of Industrial Health (an independent administrative institution) of MHLW, as required.
  If required, other specialists may be added to the inspection team.

3  Notice of Inspection

  Director-General of Labour Standards Bureau, Ministry of Health, Labour, and Welfare shall give the applicant for certification of compliance a notice in advance on the inspection if Director-General thinks it necessary to carry out the inspection in conformity to the present guidelines.

4  Contents of Inspection

  The inspection shall be carried out with respect to the following matters.

(1) Check for the state of compliance with the Industrial Safety and Health Law GLP with respect to both software and hardware of the test facilities, etc. to be inspected

(2) State of compliance with the Industrial Safety and Health Law GLP of the study to be inspected

5  Procedure of Inspection

(1) Inspection shall be carried out, in principle, in accordance with the following procedures.

1) Grasp overall state of operation in the test facility, etc.

2) Inspect the test facility, etc. and check the maintenance state of equipment and apparatus

3) Enter the site where the tests are carried out

4) Check the preparation state of study protocols, standard operating procedures, final reports, etc. and retention state for raw data, specimens, etc.

5) Check the state of activities of the section in charge of quality assurance

6) Inspect and collate the raw data, specimens, final report, etc. related to the study to be inspected

(2) As a result of the inspection, the personnel in charge of inspection shall request the applicant to submit samples of the test substance, specimens, raw data, and other materials, as required.

(3) Upon completion of the inspection, the personnel in charge of inspection shall give guidance or instructions to the relevant test facilities, etc. at the site, as required.

6  Evaluation of Inspection Results

(1) Industrial Safety and Health Law GLP Evaluation Committee
  Director-General of Labour Standards Bureau, Ministry of Health, Labour, and Welfare shall establish an Industrial Safety and Health Law GLP Evaluation Committee.
  The Industrial Safety and Health Law GLP Evaluation Committee shall evaluate the state of certification of compliance of the test facilities and studies to be inspected related to the relevant report with the Industrial Safety and Health Law GLP on the basis of the report prepared by the personnel in charge of inspection on request of Director-General of Labour Standards Bureau, Ministry of Health, Labour, and Welfare.

(2) Classification of the state of compliance with Industrial Safety and Health Law GLP
  Industrial Safety and Health Law GLP Evaluation Committee shall comprehensively evaluate the state of compliance of the test facilities, etc. and studies to be inspected with Industrial Safety and Health Law GLP and determine which of the following classification the state falls under.

Accepted:	The test facility, etc. or the study inspected complies with Industrial Safety and Health Law GLP.
Rejected:	he test facility, etc. does not comply totally or partially with Industrial Safety and Health Law GLP and it is recognized that the quality of the toxicity investigation carried out at the relevant test facilities, etc. has been impaired.

7 Treatment of Test Facilities, Etc. which Rejected Inspection

If test facilities, etc. subject to inspection refused the inspection pursuant to the present guidelines or it has been clarified that false explanation or answer was made at the time of inspection, the test facility, etc. concerned is treated as being evaluated as "Rejected" prescribed in Paragraph (2) of No. 6.

Flow chart for certification of compliance with Industrial Safety and Health Law GLP

top