Guidelines for Certification of Compliance with
Industrial Safety and Health Law GLP concerning Test Facilities, etc.
LSB Notification No. 123 dated March 17 1989
Amendment LSB Notification No. 146 dated March 11, 1997
In Japanese
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Guidelines for Certification of Compliance with
Industrial Safety and Health Law GLP concerning Test Facilities, etc.
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No. 1 Objective
The objective of the present guidelines are to prescribe
the matters related to certification of compliance of test facilities,
etc. with the Industrial Safety and Health Law GLP (referred to the standard
(ML Notification No.76 of 1988) to be satisfied by the test facilities,
etc. pursuant to provisions of Paragraph 2, Article 34-3 of the Ordinance
on Industrial Safety and Health (Labour Ministerial Ordinance No.32 of
1972. Hereinafter called the "Ordinance") to be practiced by
Director-General of Labour Standards Bureau, Ministry of Health, Labour,
and Welfare in Paragraphs (3) and (4) of Article 2-7 of I of Note in LSB
Notification No. 602 dated September 16, 1988 thereof) in order to implement
the provisions of Article 34-3 and Article 34-4 of the Ordinance.
No. 2 Applicable Test Items for Certification of Compliance
The test items for carrying out certification of compliance
(referred to carrying out confirmation on the compliance of test facilities,
etc. with the Industrial Safety and Health Law GLP by inspection, etc.
The same applies hereinafter.) shall be mutagenicity studies and carcinogenicity
studies.
No. 3 Procedures for Certification of Compliance
The certification of compliance shall be carried out
pursuant to the provisions set forth below.
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- 1 Application procedures
- (1) The person who intends to receive certification of compliance shall
apply to Director-General of Labour Standards Bureau, Ministry of Health,
Labour, and Welfare by submitting the application by Form 1, together with the documents shown in Paragraph (2), for each test facility.
The person who intends to receive the certification of
compliance by and before a specific date shall apply at least 6 months
before the relevant date.
(2) The document attached to the application form shall contain the following information.
- Date of establishment of the test facilities, etc., main party of establishment,
articles of association, site area, stories and total floor area of the
building in which the facilities, etc. are located
- Plan view of the test facilities, etc. and layout of main facilities, equipment,
apparatus, etc.
- Name, quantity, type No., etc. of the main equipment and apparatus to be
used for the test items for which the certification of compliance is supposed
to be received
- Organization and personnel composition of the test facilities, etc. name
and responsibilities of the management and other main persons, and their
curriculum vitae, research career, names of academic societies or learned
societies they belong to
- Rules related to internal audit and implementation state of the internal
audit for recent three years
- Implementation state of education and training of the personnel for these
three years
- Execution state of the study items for which certification of compliance
is intended to receive, for these 10 years
(3) The application and the documents attached in Paragraphs (1) and (2) above shall be submitted in duplicate, i.e. an original and a copy.
- 2 Certification of Compliance
- (1) The certification of compliance shall be carried out, in principle,
by examination of the application and documents attached as in Section
1 above and inspection of test facilities, etc. related to the relevant
application.
(2) Inspections associated with certification of compliance and evaluation, etc. of inspection results shall be carried out pursuant to the provisions set forth in Appendix "Guidelines for Inspection on Industrial Safety and Health Law GLP."
(3) Director-General of Labour Standards Bureau of Ministry of Health, Labour, and Welfare shall perform judgment on the compliance of the relevant test facilities, etc. with the Industrial Safety and Health Law GLP based on the results of the inspection, etc. prescribed in Paragraph (1).
3 Notification
Director-General of Labour Standards Bureau of Ministry
of Health, Labour, and Welfare shall notify to the applicant for certification
of compliance by Form 2 with respect to the results when judgment prescribed in Paragraph (3) of Section 2 is performed.
No. 4 Notification on Change
- The person who received the certification of compliance
with the Industrial Safety and Health Law GLP pursuant to No.3-3 in the
above shall notify any change in the following items to Director-General
of Labour Standards Bureau of Ministry of Health, Labour, and Welfare without
delay by Form 3.
- (1) Name of the applicant or in the case of a corporation, the name or
the address of the representative or the relevant test facilities, etc.
(2) Among the organization, personnel, facilities, equipment, apparatus,
administration, management, etc. of the test facilities, etc., those items
changes in which may influence the quality of test items for which certification
has been received
No. 5 Notification of Discontinuation
The person who received the certification of compliance
with the Industrial Safety and Health Law GLP pursuant to No.3-3 in the
above shall notify to Director-General of Labour Standards Bureau of Ministry
of Health, Labour, and Welfare without delay by Form 4 of discontinuation of a part or whole of the services related to the test items for which the certification of compliance has been received.
No. 6 Miscellaneous
Clerical works related to certification of compliance
with the Industrial Safety and Health Law GLP pursuant to the present guidelines
shall be carried out at Chemical Substances Investigation Division, Safety
and Health Department, Labour Standards Bureau, Ministry of Health, Labour,
and Welfare.
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