Quality Assurance

Quality Assurance

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Japanese Ministry of Agriculture, Forestry and Fisheries

Preamble to Japan's GLPs

GLP Standards Contents

59 NohSan No. 3850
August 10 1984
Director-General of Agricultural Production Bureau.
Ministry of Agriculture, Forestry and Fisheries (MAFF)

On Good Laboratory Practice Standards for Toxicological Studies on Agricultural Chemicals

Some countries have been adopting a Good Laboratory Practice (GLP) for proper conduct of toxicological studies in recent years.

In Japan, the safety of an agricultural chemical has been ensured strictly and thoroughly. However, to make more accurate and strict evaluation of an agricultural chemical, Good Laboratory Practice Standards (GLP Standards) is intended to be introduced in view of the conspicuous progress of toxicological and related studies as well as enhancement of capability of Japanese testing facility (hereinafter referred to as "testing facility").

Since GLP Standards will contribute to further improvement of the standards and certification system and to promotion of the vitality of private sectors, the introduction of GLP Standards has been seriously awaited by all the parties concerned in Japan and abroad.

In this situation, Good Laboratory Practice Standards for toxicological studies on agricultural chemicals" (hereinafter referred to as "Standards") as attached has been established for toxicological studies to be conducted for obtaining registration with the provision of Item I of Article 2 of the Agricultural Chemical Regulation Law (Law No. 82, 1948) in this connection you are advised to observe the Standards hereafter taking account of the provisions as stated below at your toxicological studies and data compilation thereof.

l. Purpose of Good Laboratory Practice Standards

Good Laboratory Practice standards are to be set forth further to assure the quality and integrity of toxicological study data on agricultural chemicals submitted in order to support application for agricultural chemical registration pursuant to the provision of Paragraph 2 of Article 2 of the Agricultural Chemicals Regulation Law through the self observance system of the GLP Standards by testing facility.

2. Effective date of Good Laboratory Practice Standards

Good Laboratory Practice Standards shall come into effect on the 1st October, 1984.

3. Scope (Applicable study) of Good Laboratory Practice Standards

Good Laboratory Practice Standards are applied to the following studies to be commenced from the time specified in section 2.

a. Acute oral toxicity study
b. Acute dermal toxicity study
c. Acute inhalation toxicity study
d. Primary eye irritancy study
e. Primary dermal irritancy study
f. Dermal sensitisation study
g. Acute delayed neurotoxicity study
h. Subchronic oral toxicity study
i. Subchronic dose dermal toxicity study
j. Subchronic inhalation toxicity study
k. Subchronic neurotoxicity study
l. Chronic toxicity study
m. Oncogenicity study
n. Combined chronic toxicity/oncogenicity study
o. Reproduction study
p. Teratogenicity study
q. Mutagenicity testing

4. Handling of Toxicological Data Applied to Good Laboratory Practice Standards in Examination by Agricultural Chemical Registration Authority.

Toxicological data that satisfy the both conditions given below are accepted as the data for Agricultural chemical safety evaluation in examination by the registration authority.

i. Testing facility which has conducted the toxicological study is confirmed by Director-General of Agricultural Production Bureau, Ministry of Agriculture, Forestry and Fisheries (hereinafter referred to as "the Director-General") every three years to meet the GLP standards concerning the organization and operation, etc. in the latest three years.

ii. In the event that the quality and integrity of the data is in doubt during examination of the data and the Director-General issues a note to that effect to applicant for registration who has submitted the data, the said applicant has the confirmation by the Director-General on the quality and integrity of the study.

5. Petition for Confirmation and Inspection

  1. Any person who is to have confirmation by the Director-General (section 4.) shall submit a petition to the Director-General through Director of Agricultural Chemicals Inspection Station, Ministry of Agriculture, Forestry and Fisheries. For confirmation specified in section 4. ii., a petition prepared and filled out followIng the example of Form 1 should be submitted, and for confirmation specified in section 4. ii., a petition prepared and filled out following the example of Form 2 should be submitted.
  2. The Director-General will have either of the following persons conduct inspection for confirmation in the event that the petition specified in 5(l) is submitted.
    1. a. Persons with expert knowledge or experience of inspection work relating to testing facilities, records and specimens of toxicological study, etc. who are designated by the Director-General out of Agricultural chemicals regulation personnel defined in MAFF Ordinance No. 2, 1971.
    2. b. Persons of learning and experience in toxicology who are designated by the Director-General.
  3. The Director-General will inform (a) Scheduled date of inspection and (b) Name(s) of inspector(s) to those persons who have submitted petition for confirmation prior to the conduct of the inspection.
  4. After the inspection, the Director-General will notify those who have submitted petition for confirmation of the result of inspection.

6. Documents to be Submitted Together with Toxicological Study Data

Applicants for agricultural chemical registration should submit the following documents together with the toxicological study data.

a. Documents showing the outlines of the testing facility (The documents should give the following information: date of foundation of the testing facility, name(s) of founder (or sponsor), organization, personnel, financial status, size of the testing facility area and total floor area, building layout, specifications of installation.)

b. In case that two or more testing facilities collaborate for one joint study, document showing explanatory information on the relationship among the testing facilities involved.

c. Curriculum vitae of researchers including management, the study director and major personnel responsible for the study on experiences in research and academic societies to which the researcher belongs.

d. Document specifying QAU personnel names and titles.

e. Statement prepared and signed by the testing facility management assuring that the toxicological study has been carried out in compliance with the GLP standards.

Petition for Confirmation

Date:

To: Mr Director-General.
Agricultural Production Bureau,
Ministry of Agriculture, Forestry and Fisheries

From: Name (with signature) and address (in case of legal person the title of the legal person and the name of its representative)

This is to petition for your confirmation of the compliance of the testing facility given below with Good Laboratory Practice standards. Documents required for confirmation are attached.

  1. Name of testing facility
  2. Location of testing facility

NB: The documents giving the following information should be attached:

  1. Data giving the outline of the testing facility (the data should give information on the date of foundation of the testing facility, name(s) of founder (or sponsor(s)), organisation and the staff, size of the testing facility site, total floor area, building layout, kinds and details of the facilities).
  2. The details of the conduct of toxicological studies by the testing facility in the last three years. (The type, scale, etc. of studies carried out should be given for each year. No need to specify sponsor/test substances.)
  3. Financial status of the testing facility.
  4. Curriculum vitae of researchers including management, the study director and major personnel responsible for the study on experience in research and academic societies to which the researcher belongs.
  5. Any other data required for confirmation of the compliance of the testing facility with Good Laboratory Practice standards.
PETITION FOR CONFIRMATION

Date:

To: Mr Director-General,
Agricultural Production Bureau,
Ministry of Agriculture, Forestry and Fisheries

From: Name (with signature) and address (in case of legal person the title of the legal person and the name of its representative)

This is to petition for your confirmation of the quality and integrity of the toxicological study data described below for which we have been given a note dated the _____ day of _______ , 19__ saying that the quality and integrity of the data is in doubt.

Documents related to the toxicological study are attached.

  1. Name of toxicological study data the quality and integrity of which is in doubt.
  2. Name and location of the testing facility by which the toxicological study has been conducted.

NB: The following documents should be attached:

  1. Protocol of the toxicological study
  2. Location of the archive where the specimen, raw data, all records, final report and correspondence related to the toxicological study are retained.