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No.30-Shouan-4216
November 30, 2018
To whom it may concern:

Director, Plant Products Safety Division, Food Safety
and Consumer Affairs Bureau, the Ministry ofAgriculture, Forestry and Fisheries

Guidance for the preparation of the document annexed to the application for the GLP inspection(Notification 30 Shouan No.4216, issued on November 30, 2018 by the Director of Plant
Products Safety Division, Food Safety and Consumer Affairs Bureau, Ministry ofAgriculture, Forestry and Fisheries)
Confirmation of compliance with the standards for ensuring the reliability of specified test results(hereinafter referred to as “Agricultural Chemicals GLP Standards”) provided in Article 3, paragraph 2 of
the Agricultural Chemicals Regulation Act (Act No. 82 of 1948) as amended pursuant to Article 1 of the
Act partially amending the Agricultural Chemicals Regulation Act (Act No. 53 of 2018) is to be conductedin accordance with “Inspection and confirmation of compliance with the standard provided for in Articles 5
to 19 of the Ministerial Ordinance on Good Laboratory Practice for Agricultural Chemicals” (Notification
30 Shouan No.4215, issued on November 30, 2018 by Director-General, Food Safety and Consumer
Affairs Bureau, Ministry of Agriculture, Forestry and Fisheries) (herein after referred to as "the notificationof the Director-General"). Documents requested in 3 (1) of the notification of the Director-General must be
submitted in accordance with the attached “Guidance for the preparation of the document annexed to theapplication for the GLP inspection”
Your understanding is greatly appreciated.
Please also note that apart from the attachment, documents are requested as provided in the Notice
below in order to conduct the inspection of compliance with the Agricultural Chemicals GLP Standards.
Meanwhile, ‘Guidance for the Preparation of the document annexed to the application for GLP
1

inspection’” (The notification, Ref. No. 15-shouan-7396, issued on March 31, 2004 by the DirectorGeneral, Plant Products Safety Division, Food Safety and Consumer Affairs Bureau, Ministry ofAgriculture, Forestry and Fisheries) shall be abolished upon this notification.
Notice
The following documents are to be submitted to the Director-General, Food Safety and Consumer
Affairs Bureau, Ministry of Agriculture, Forestry and Fisheries approximately two weeks before theinspection.
1

Types of tests and details of test-related works concerning specified test results, which arescheduled during the inspection period
Describe only when any test-related work concerning specified test results is scheduled during theinspection period.

2

Copies of study plans
Submit one copy of a study plan for an agricultural chemical that has already been completed or isbeing conducted. In case there are more than one such studies, submit a study plan that has a longer
study period.

3

Copies of Standard Operating Procedures (SOPs)
Submit one copy of all SOPs relating to the Agricultural Chemicals GLP Standards. However, if theinspection is the second or subsequent time, submit a copy of the SOPs indicated by the inspector basedon Article 4 of the notification of the Director-General.

2

Attachment
Guidance for the preparation of the document annexed to the application for the GLP inspection･ This is a guidance for preparation of documents to be annexed to the application for, or submitted in advance of, theinspection and confirmation of compliance with the GLP standards of a test facility. Please submit them to the
Director-General of Food Safety and Consumer Affairs Bureau, Ministry of Agriculture, Forestry and Fisheries by
about two months prior to the inspection, so that the inspectors in charge are able to review the documents in advanceof the inspection.
･ The prepared documents will be used for the preliminary hearings, explanation of the outline of the test facility on
the first day of the inspection (investigation), facility-based inspection of the test facility, interviews of test facility
management, and other related matters.
･ The documents must be prepared in JIS A4 size. However, documents such as the layout of the test facility, which
would become illegible in A4 size, may be prepared and submitted in JIS A3 size.
･ The contents of the documents must, in principle, reflect the status of the test facility at the time of preparation of the
documents. If the status at the inspection (investigation) greatly differs from that documented, please submit acomparative table describing the differences.
･ Photographs attached to the documents can be substituted for photo-quality clear copies.
･ Attach a table of contents, and number all pages consecutively throughout the documents. No index is required.
･ If the contents are the same, documents for different GLP standards can be combined by listing together the different
terms used for individual GLP standards.
[Names of laws shortened in this guidance] In this guidance, the names of the following laws are shortened as below.
*Act on Pharmaceuticals and Medical Devices Agency, Independent Administrative Agency: Act on the
Pharmaceuticals and Medical Devices Agency*Act on the Regulation of Manufacture and Evaluation of Chemical Substances: Chemical Substances Control Law*Industrial Safety and Health Act: Safety and Health Law*Act on Safety Assurance and Quality Improvement of Feeds: Feed Safety Law*Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices:
Pharmaceutical Affairs Law-1-

Table of Contents
1 Test Facility Inspected (Investigated)

4(1) Name (Japanese and English)

4(2) Address (Japanese and English)

4

2 Areas or Items of the Studies

4

3 Conduct of the Studies Relevant to the Application

5

4 Regulations Concerning Internal Audits and Conduct of Internal Audits over the Last Three Years

6

5 Historical Background (Established date, GLP-applied studies initiation dates, dates and results of inspections(investigations) conducted by authorities, and other related background information)

7

6 Photograph or Illustration of the Entire Facility and Figures or Illustrations of Test Facility Premises
Location (Floor Plan of the Test Facility)

8(1) Photograph or illustration of the entire facility

8(2) Figures or illustrations of test facility premises location (floor plan of the test facility)

8

7 Area of the Test Facility Site

98 Number of Stories and Total Floor Area of Premises Equipped with Apparatus (Premise Area)

99 Floor Plans of Premises (Location of Major Facilities, Apparatus, and Other Related Information)

10

10 Organization and Personnel of Test Facility and Other Related Information

11(1) Company organization

11(2) GLP organization

11(3) Composition and other related information for GLP organization personnel

131) Total number of GLP organization personnel (including dispatched personnel, temporary workers, foreign
personnel, and all other personnel)
132) University departments, academic degrees, licenses, and other related information for GLP organization
personnel
133) Composition of GLP organization personnel by unit
14

11 Summary and Recent Status of Personnel Education, Training, and Other Related Information

15

12 Study Director’s Experience in Conducting Studies

16

13 Work Contents, Names, Job Titles, Licenses, Job and Research Careers, Academic Society Membership, and Other
Related Information for Test Facility Management and Other Major Personnel

17

14 Organization of Quality Assurance Unit (QAU)

19

15 Major Work of GLP Organization Personnel

19

16 Animal Housing Capacity of Study Unit

19

-2-

17 Floor Plans, Circulation Diagrams and Air Conditioning Diagrams for Individual Operation Zones of
Safety (Toxicity and Other Related Information) Study Unit

20(1) Floor plans for individual operation zones

20(2) Circulation diagram

21(3) Air conditioning diagram

22

18 Handling and Disposal of Waste

24

19 Names, Quantities, Models, and Other Related Information of Major Apparatus used for Studies (Typesand Nature of Apparatus)

24

20 Status of Animal Housing Facility

25(1) Housing conditions

25(2) Supplier of analysis data and frequency of analysis on feed, water, bedding

25(3) Status of microbial monitoring in animal housing rooms and other related information

25

21 Environmental Control, Monitoring Procedures, and Other Related Information of Important Zones

26

22 Status of Washing, Disinfection, and Other Related Information

27(1) Use of detergents and disinfectants

27(2) Use of pest control agents27

23 Animals and Care of Animals

28(1) Methods of receipt, quarantine, and care of animals

28(2) Handling of diseases or conditions

29(3) Management of feed, water, animal care instrument, detergents, and other related information

29

24 Master Schedule

30

25 Standard Operating Procedures (SOPs)

31(1) SOPs, formats, and other related information specified in SOPs

31(2) Procedures for preparation, revision, disposal, and other related information of SOPs

31(3) List of titles in SOPs

31

26 Flow Chart of Safety (Toxicity) Studies

32

27 Overview of Computerized System

34

28 Status of Outsourcing of Studies

35

29 Multi-site Studies

37

30 Problems Found in Past GLP Inspections (Investigations) and Status of Improvement

37

-3-

1 Test Facility Inspected (Investigated)(1) Name (Japanese and English)
When multiple facilities are inspected (investigated), write the names of individual test facilities.
(Example)○○株式会社○○研究所

English name ○○ COMPANY, LIMITED, ○○ INSTITUTE(2) Address (Japanese and English)
When multiple facilities are inspected (investigated), write the addresses of individual test facilities.
(Example)○○県○○市○○1-2-3

English address 1-2-3, ○○, ○○, ○○2 Areas or Items of the Studies* Specify “the area of the study” for GLP standards based on the Agricultural Chemicals Regulation Law, “the itemof the study” for GLP standards based on the Act on the Pharmaceuticals and Medical Devices Agency, Chemical
Substances Control Law or Safety and Health Law and “the type of the study whose compliance status is to be
confirmed” for GLP standards based on the Pharmaceutical Affairs Law (veterinary drugs).
* For GLP standards based on the Chemical Substances Control Law, when only some phases of a study on
bioconcentration, etc. or toxicity, etc. are applied for the confirmation, specify the phases relevant to theconfirmation by giving descriptive titles such as “a study on bioconcentration, etc. (study on partition coefficientof chemical substances between 1-octanol and water)” or “a study on toxicity, etc. (28-day repeated dose toxicity
study).”* For GLP standards based on the Pharmaceutical Affairs Law (veterinary drugs), specify the studies for which
confirmation is requested, including those that have been intermitted for three or more years or have never been
conducted but are practicable.
* For GLP standards based on the Agricultural Chemicals Regulation Law or the Act on the Pharmaceuticals andMedical Devices Agency, specify the studies for which confirmation is requested, including those practicable.

-4-3 Conduct of the Studies Relevant to the Application(1) For studies completed within the latest three years, specify the titles and serial numbers of the studies, GLP standards
applied, name(s) of test item(s) (abbreviations or bynames acceptable), name(s) of study director(s), initiation andcompletion dates of the studies and remarks, if any, for each item or type of study in a table format.
(Example)
Studies completed within the latest three years
Type of

Title and serial

study

number of study

××study ××study, A001

GLP

Test

Study

(C) (S)□□○○ ○○(C) (S)∆∆○○ ○○(P) (A)○○study ○○, B○○

Study

Remarks

Applied* item(s) director(s) initiation date completion date(P) (A)××study, A002

Study(C) (S)○○○○ ○○(P) (A)

year ○○/

year ○○/

month ○/

month ○/

day○

day○

year ○○/

year ○○/

month ○/

month ○/

day○

day○

year ○○/

year ○○/

month ○/

month ○/

day○

day○

Note :( C); Chemical Substances Control Law, (S): Safety and Health Law, (P); the Pharmaceutical Affairs Law, (A);the Agricultural Chemicals Regulation Law(2) Report the annual number of studies conducted within the last decade for each study type. Count the GLP-appliedstudies separately from other studies.
* Count the number of studies based on the study initiation year.
(Example)
Number of studies conducted (latest 10 years)
Type of study
Year××studyyear○○(including○○study○

GLP-appliedstudies)year○○(including○(including

studies)(including○

GLP-applied･･･○

GLP-applied･･･○

GLP-applied･･･

studies)○

GLP-appliedstudies)
year○

○

･･･

○

(including

studies)○

GLP-applied○(including

studies)-5-

4 Regulations Concerning Internal Audits and Conduct of Internal Audits over the Last Three Years
Describe the regulations concerning internal audits.
For internal audits conducted over the latest three years, indicate the annual number of audits conducted for eachstudy (status of the conduct of the study, final report, and other relevant information), facility, and other relevant
details.
(Example)
Regulations concerning internal audits are provided in the following Standard Operating Procedures (SOPs).
SOP number

Title

SOP/QAU/***Work of Quality Assurance Unit

SOP/QAU/***･･･

SOP/QAU/***

･･･

･･･

･･･

Internal audits conducted over the last three years
Numbers of internal audits on studies
Year

Audit/inspection○○study××study∆∆study□□study

item
Study plan

○○

○○

○○

○○

Status of conduct

○○

○○

○○

○○

Final report

○○

○○

○○

○○

･･･

○○

○○

○○

○○

of study

･･･

･･･

･･･

･･･

･･･

･･･

･･･

･･･

･･･

･･･

･･･

･･･

･･･

･･･

･･･

･･･

･･･

･･･

･･･

･･･

･･･

･･･

･･･

･･･

･･･

･･･

･･･

･･･

･･･

･･･

Numbers of internal audits on facility and other relevant information
Year

Apparatus/

Test item/

Sample/equipment

reagent

Material

Wastes

Education/

Otherstraining()

storage
○○

○○

○○

○○

○○

○○

○○

○○

○○

○○

○○

○○

○○

○○

○○

○○

○○

○○

-6-

5 Historical Background (Established date, GLP-applied studies initiation dates, dates and results ofinspections (investigations) conducted by authorities, and other related background information)
Describe the historical background of the facility (establishment, transfer, merger with other units, etc.), initiation
dates of GLP-applied studies, etc.
1) Year and month of establishment
2) Purpose of establishment
3) Founder
4) Year and month of initiation of GLP-applied studies (write individually for each study type)5) Name of the computerized system, year and month of initiation of its development and operation
6) Dates, evaluation results, and notification dates of the results of GLP inspections (investigations) conductedby authorities
7) Change(s) including extension and reconstruction of the facility (Specify any change(s) made since the lastinspection (investigation) in the second and later inspections (investigations).)(Example)
Year Month

Eventsyear○month○Established in ○○City, ○○Prefecture as a clinical inspection company

year○month○

Laboratory transferred to ∆∆City, ∆∆Prefecture and renamed Safety Research Centeryear○month○

GLP application on ○○study and ××study initiatedyear○month○

SPF animal house (rats, mice) extended

year○month○

Name changed to Safety Research Laboratory following the institutional reform,
three-offices-per-section system establishedyear○month○

GLP application on ∆∆study initiatedyear○month○

Central system for managing study data and animals introduced

year○month○day○-○ ∆∆GLP inspection by ○○Ministry (evaluation results notified on year○month○day○,evaluated as○)year○month○

GLP application on □□study initiatedyear○month○Archive facility constructed

year○month○

Central system for managing study data and animals modified

year○month○day○-○ ∆∆GLP inspection by ○○Ministry (evaluation results notified on year○month○day○,evaluated as ○)year○month○

SPF animal house (rats, mice) reconstructed and rabbit house extended-7-

6 Photograph or Illustration of the Entire Facility and Figures or Illustrations of Test Facility
Premises Location (Floor Plan of the Test Facility)(1) Photograph or illustration of the entire facility
Submit a photograph or illustration depicting the entire outline of the facility (including the unit(s) inspected(investigated) as well as any other units such as factories, etc. built on the site).
(Example) Attach a photograph, etc.
(2) Figures or illustration of test facility premises location (floor plan of the test facility)
The figure or illustration does not need to be an exact miniature, as long as it depicts the layout of the facility.
Indicate the GLP-applied zones (or the corresponding parts if the facility is only partly covered by GLP) as italics,
shaded areas, bold lines, colored areas, and other such indications, and specify the name of the facility, room numbers,
and other related details.

Safety Study Building A

Animal Study

Microbial

Building

Study Building

Safety Study Building B

First Manufacturing Plant(Example)

Entrance
Archive Room
(2nd Floor, Room 210)
Administrative Building

Generation
Facility

Parking Lot
Welfare Facility:GLP-applied zones-8-

Sewage Facility

Second Manufacturing Plant

Power

Incinerator

7 Area of the Test Facility Site
Indicate the area of the test facility site.
(Example) Area of the site ○○○○m2

8 Number of Stories and Total Floor Area of Premises Equipped with Apparatus (Premise Area)
Indicate the total floor area of premises equipped with apparatus, etc. and the number of stories and floor area foreach of the premises.
Separately indicate the floor areas of GLP zones and non-GLP zones.
If there is more than one GLP standard applied to the facility, specify the titles of the corresponding GLP
standards in the remarks column.
(Example)
Facility name

Number ofstories

Research Building ○-story building

Floor area
GLP zone

Non-GLP zone

○○m2

Total

○○m2

○○Laboratory○th floor○○m2

Archive Room○th floor○○m2

Lab Workers’ Office○th floor○○m2

Animal Building
Animal Housing
Room
Animal Dissection
Room
Feed Mixing
Room○-story building

○○m2

○○m2

○th floor○○m2○th floor○○m2○th floor○○m2

Pathology Room○th floor○○m2

Microscopy Room○th floor○○m2Administrative○-story building
Building
Administration○th floor
Office

○○m2

○○m2
○○m2

Quality Assurance
Room○th floor○○m2

Waste Storage○th floor○○m2

Effluent Treatment
Facility○th floor○○m2

Total Floor Area

○○○m2

○○○m2

-9-

○○○m2

Remarks

9 Floor Plans of Premises (Location of Major Facilities, Apparatus, and Other Related Information)
Provide a floor plan depicting the location of major apparatus, etc. for each floor of major facilities. Attach
photographs if necessary.
(Example) Safety Study Building A

細胞培養室
Cell
culture room

Data
processing room
データ整理室

パス

Pass
ルー
room

Laboratory
実験室ム

Measurement
測定室１
room
1

Corridor

廊
下Animalroom 1動物室１廊
下CorridorCorridor

器材室 room
Instrument

Measurement
測定室２
room 2廊
下

Instrument
器材室 room

動物室２
Animalroom 2
器材準備室

パス
Pass
ルー
room
ム

Instrument preparation room

Pass
パス
room
ルー

ム

パスルーム
Pass room
Autoclave
オートクレーブ
Washingroom
洗浄室

Machineroom
機械室- 10 -

10 Organization and Personnel of Test Facility and Other Related Information(1) Company organization
Provide a table, etc. illustrating the relationship between the company organization and the GLP organization.
Mark the GLP organizations, e.g., by drawing boxes around them.
Write the job titles of GLP organization key personnel, in the context of company organization and GLP
organization. If required, write the names of the personnel.

(Example)
President

Pharmaceutical
Department

Quality Control Division Chief, responsible for ○○Pharmaceutical Division

Board of Directors

General Affairs Department
Sales
Department

First Sales Division

Manufacturing
Department

Manufacturing Management Division

Second Sales DivisionFirst Manufacturing Division
Second Manufacturing Division

R&D Department

Safety Research Center
Director of the Center, Facility Manager
Pathology Division

Research Management Division: Units in charge of GLP-applied studies(2) GLP organization
Provide a chart describing the roles of test facility management, Study Director, testing unit, Quality Assurance
Unit (QAU), archive unit, test item handling unit, animal care unit, pathology unit, system management unit,
equipment management unit, facility management unit, etc. and the outline of the line of command. Include thenames of the responsible persons and the personnel of individual sections.
* Describe the relationship between the GLP organization and the company organization. For example, if the test
facility management is the director of the Safety Research Center, indicate the position in the GLP organizationand then, the position in the company in parentheses, e.g., Test facility management (Director of the Safety
Research Center).

- 11 -

(Example)

Testing運営管理者
Facility Management(Director of the Safety○○ ○○ Research（安全性研究所長）
Center)QAUManager
責任者：○○○○(Manager of the Quality Assurance Room, R&D（研究部開発本部信頼性保証室室長）
Department)(Assistantmanager)○○ ○○（係長）、○○
○○

Study
Directors
試験責任者
(Cell
Toxicity Research Group)（細胞毒性研究グループ）○○○○、○○ ○○
(Testing
Research Group 1)（試験研究第１グループ）○○○○(Testing
Research Group 2)（試験研究第２グループ）○○○○、○○ ○○
Testing
Unit
試験実施部門
(Cell
Toxicity Research Group)（細胞毒性研究グループ）○○ ○○*※、○○ ○○*※、○○ ○○、○○ ○○、○○ ○○、○○ ○○(Testing（試験研究第１グループ）
Research Group 1)○○ ○○*※、○○ ○○、○○ ○○（試験研究第２グループ）(Testing
Research Group 2)○○ ○○*※、○○ ○○*※、○○ ○○、○○ ○○、○○ ○○、○○ ○○、○○ ○○、○○ ○○被験物質取扱部門
Test
Item Handling Unit

Personnel responsible for the
被験物質管理責任者：○○
management of test items*○○※○○ ○○*※

資料保管部門Archive Unit

Personnel responsible for archive facility

資料保管施設管理責任者：○○ ○○○○ ○○Facility
Management Unit
施設管理部門Personnel responsible
責任者：○○○○○○ ○○Apparatus
Management
機器管理部門※Unit* 、○○ ○○※*
Personnel責任者：○○
responsible○○* Indicates personnel holding
additional posts※- 12 -

は業務の兼任者を示す

QAU

(3) Composition and other related information for GLP organization personnel
1) Total number of GLP organization personnel (including dispatched personnel, temporary workers, foreign
personnel, and other personnel)
Indicate in parentheses the number of dispatched personnel, temporary workers, etc. included in the count.
Indicate the name of the employment agency beside the number of dispatched personnel.
(Example) ○○ (including ○ dispatched personnel from ∆∆ Employment Agency)
2) University departments, academic degrees, licenses, and other related information for GLP organization
personnel
Indicate in parentheses the number of dispatched personnel, temporary workers, etc. included in the count.
Indicate the name of the employment agency beside the number of dispatched personnel.
(Example)
University
DegreeLicensedepartment
Certified
Master Doctor Veterinary Medical Pharmacy Clinicaletc.
technologist toxicologist

Veterinary
Medicine
Pharmacy
Agriculture
ScienceEngineering
Fishery
science
OthersJuniorcollege
Vocational
schoolHigh school
Junior-highschool
Total

3
1
1
8
2
1

1
3*

Japan
Society of
Quality
Assurance
QAP

3
1
1

3

2
1

1

3

1

1
0
3

1

13

1

12 (3)
2
47

3

7

6

1

1

2

1

*one from ○○ department, one from □□ department
The number in parentheses represents dispatched personnel from ∆∆ Employment Agency
Note: The following are some examples of the relevant licenses certified by academic societies, etc.
Approved Pathology Specialist (The Japanese Society of Veterinary Science), Approved
Pathology Specialist (The Japanese Society of Toxicologic Pathology), Certified
Toxicologist (The Japanese Society of Toxicology), Japanese Teratology Societyapproved Reproductive and Developmental Toxicologist (The Japanese Teratology
Society), Laboratory Animal Technician (Japanese Society for Laboratory Animal
Resources), QAP (Japan Society of Quality Assurance), Approved Engineer (Japan
Association of Contract Laboratories for Safety Evaluation), Qualified Laboratory
Technologist in Experimental Pathology (The Japanese Association of Histotechnology),
Advanced Electron Microscopy Techniques (The Japanese Society of Microscopy), etc.

- 13 -

1

3) Composition of GLP organization personnel by unit
Indicate the number of personnel for individual units, e.g., Quality Assurance Unit (QAU), Testing Unit, Archive
Unit, and all other units.
(Example)
Unit

Employees

Dispatchedpersonnel, temporary
workers, etc.

Total

Test Facility Management

1

0

1

Quality Assurance Unit

3

0

3

Testing unit

0

20

0

2 (including 1 holding
additional post)

Test substance handling unit20
2 (including 1
holding additional
post)
2

2

4

Facility management unit

2

3

5

Total

29 (1)

5

34 (1)

Archive unit

* If there are personnel holding additional posts, indicate in parentheses the number of such
personnel included in the count in the column for the secondarily engaged unit.

- 14 -

11 Summary and Recent Status of Personnel Education, Training, and Other Related Information
Categorize the education and training events relevant to GLP or the conduct of GLP-applied studies into thefollowing categories 1) through 5), and summarize each event.
1) New employee education
2) On the job training (OJT)3) In-house training (training at the company, including invitation of lecturers)4) Out-company training
5) Participation in academic meetings, etc.
In addition, describe the status of the implementation of such events over the last three years or last year (contents(title), trainee (participant) names, etc.).
* Describe the status of the implementation over the last year for GLP based on the Act on the Pharmaceuticals
and Medical Devices Agency or Feed Safety Law, over a period from the beginning of the last fiscal year until today
for GLP based on the Pharmaceutical Affairs Law (veterinary drugs) and over the last three years for GLP based on
the Agricultural Chemicals Regulation Law, Chemical Substances Control Law or Safety and Health Law.
(Example)
Summary of education, training, etc.
1) New employee education
1. GLP training at company orientation
Intended for new employees, held in early April, based on the GLP educational policy....
･･･
3) In-house training
1. GLP education, computer training
Intended for new employees, transferees, etc., held in July for thorough understanding of the GLP systemand safety....
･･･5) Academic meetings, etc.
1. Various academic meetings
Participation by those interested in fostering and advancement of specialized knowledge and....
Status of implementation
1) New employee education
1. GLP education
Date: April 2-14, year○○
Lecturer: ○○ ○○ Trainee: ○○ ○○･･･2) In-house training
1. GLP education, computer training
Date: July 12, year○○
Lecturer: ○○ ○○ Trainee attribute: person responsible for ○○, person in charge of ○○, ○ in total- 15 -

･･･
5) Academic meetings, etc.
The Japanese Society of ×× November 14-17, year○○
Participants: ○○ ○○, ○○ ○○, ○○ ○○12 Study Director’s Experience in Conducting Studies
For each Study Director, indicate the numbers of studies conducted in the past and those conducted as the Study
Director.
For Study Directors who have conducted more than 10 studies, it is acceptable to write the approximate number,e.g., “about ○.”(Example)
Name
○○ ○○

○○ ○○

Number of studies conducted (as the Study Director)○○ study:

38 (26)

×× study:

8 (6)∆∆ study:

5 (3)××× study:

58 (42)○○○ study

:

4 (1)

- 16 -

13 Work Contents, Names, Job Titles, Licenses, Job and Research Careers, Academic Society Membership,
and Other Related Information for Test Facility Management and Other Major Personnel
For the personnel specified in 1) to 9), specify the work contents, names, birth dates, job titles, academic degrees,
qualifications and licenses, job and research careers, training experience, academic society membership andorganizational affiliations. Attach a list of research paper publications and presentations.
1) Test facility management
2) Study Director (list all personnel potentially appointed as the Study Director)
3) Personnel responsible for archive facility4) Personnel responsible for the management of test and reference item (if appointed)
5) Personnel responsible for animal care (if appointed)
6) Personnel responsible for pathology (if appointed) and personnel conducting microscopic examination inhistopathology (if appointed)7) All personnel in charge of Quality Assurance Unit (QAU)
8) Personnel responsible for the management of the apparatus (if appointed)9) Other personnel responsible (if appointed)*1 Write the names of the currently appointed personnel.
*2 For 7), notify any sharing of work in Quality Assurance Unit.
*3 For research careers and training experience, describe the contents of the studies conducted in the parent
organizations (or universities, etc.), indicate any experience of GLP studies, and summarize the research
performance (research papers, presentations at academic meetings, etc.). For research papers, presentations at
academic meetings, etc., include only those relevant to the studies whose compliance status with GLP is to be
confirmed. If there are more than five papers for each study area (e.g., general toxicity, pathology, etc.), describe
five major papers for each area and write “○○ more papers.”*4 Item 3) “Personnel responsible for archive facility” refers to the personnel responsible for storing samples andmaterials for GLP based on the Chemical Substances Control Law or Safety and Health Law, the personnel
responsible for the management of the archive for GLP based on the Agricultural Chemicals Regulation Law orFeed Safety Law and the personnel responsible for archive facility for GLP based on the Pharmaceutical Affairs
Law (veterinary drugs) or the Act on the Pharmaceuticals and Medical Devices Agency.
*5 For item 8), specify the names of major equipment managed by the personnel (notify accordingly if different
individuals are appointed for the individual study area or facility) and names and job titles of the personnel.
It is acceptable to write the names of the major equipment managed by the personnel in 23, if notified accordingly.

- 17 -

(Example)
Work content
Name
Birth date
Job title
Degree/Qualificationand license

Job career

Research
careerandTraining
experience
Academicsocietymembership

Study Director (since year○month○ until now)○○ ○○year○○month○○day○○
Safety Research Department, Pathology Research Group Leader
May 1977 obtained the Pharmacy license (no. ○○)March 1979 obtained a Master’s degree in Pharmacy
March 1993 certified as an Approved Pathology Specialist by the Japanese Society of
Toxicologic Pathology (no.○○)April 1993 certified as an Approved Pathology Specialist by the Japanese Society of Veterinary
Science (no. ○○)1977 graduated from Department of Pharmaceutical Chemistry, Faculty of Pharmaceutical
Science, ○○ University
1979 finished Master’s graduate course in Pharmaceutical Science, ○○ University Graduate
SchoolApril 1979~March 1985 worked as a First Research G Researcher at Safety Research Center,○○ Pharmaceuticals Co. Ltd.
April 1985~March 1993 worked as a Pathology Research G Researcher at Safety ResearchCenter, ○○ Pharmaceuticals Co. Ltd.
April 1993~today working as a Pathology Research G Principal Researcher at Safety ResearchCenter, ○○ Pharmaceuticals Co. Ltd.
Pathology
April 1982~today○○ Pharmaceuticals Co. Ltd.: papers
1~3
April 1983~March 1985
Research student in Pathology Course ○, ○○University: papers
4~5○○ study
April 1979~March 1985○○ Pharmaceuticals Co. Ltd.: papers
6~10
×× study
April 1981~today○○ Pharmaceuticals Co. Ltd.: papers
10~15Japanese Society of Pathology, Japanese Cancer Association, Japanese Society of Toxicologic
Pathology

Organizational
Japanese College of Veterinary Pathologists (member)affiliation* Attach a list of research papers and presentations at academic meetings.

- 18 -

14 Organization of Quality Assurance Unit (QAU)
State whether Quality Assurance Unit (QAU) is established as a permanent organization.
(Example) QAU is established as a permanent organization.

15 Major Work of GLP Organization Personnel
Summarize all work conducted in the relevant testing facility. Briefly describe the content of any work otherthan those covered by GLP (non-GLP work).
(Example)･○○ study･□□ study･∆∆ study･(×× study)

16 Animal Housing Capacity of Study Unit
Indicate the animal housing capacity for each premise.
Notify accordingly if any of the premises are simultaneously or alternately used for housing more than one animal
species.
Notify if a premise has no animal housing capacity.
(Example)
PremiseRoom no.

GradeAnimalspecies

5436Barrier
Barrier
BarrierConventional

Mice
Mice
Rats
Rabbits
Guinea pigs

5
1
1

Conventional
Conventional
Conventional

Rats
CattleRed seabream

Numberofrooms

Building 1

101~105
201~204
301~303
Building 2 201~206 *rabbits orguinea pigs used
depending on thetype of the study.
207~211
Cow barn
101
Fish
206
medicalward- 19 -

Quantity of
housing units(cages/tanks)
30×5 cage
30×4 cage
25×3 cage
50×6 cage
25×6 cage

Maximum
capacity (size)

30×5 cage
6 pens0.3t tank×10750
62,000 (15g)

1,500
600
375
300
450

17 Floor Plans, Circulation Diagrams and Air Conditioning Diagrams for Individual Operation
Zones of Safety (Toxicity and Other Related Information) Study Unit
(1) Floor plans for individual operation zones
1) Prepare floor plans depicting the location of major apparatus, equipment, etc. in rooms for individual animal
housing zones and other operation zones. Distinguish between the GLP zone and non-GLP zones, and specify
the names (purposes) of the rooms. Attach photographs of major apparatus if necessary.
* Clearly indicate the boundaries of barrier housing rooms, e.g., in bold letters.
(Example)

研究棟別館
Researchbuilding annex
1F

Microbiallaboratory
微生物実験室Scale
天秤室laboratory

Study
operation zone
試験操作区域
Test
and reference
被験物質及び対照
items
handling zone
物質取扱室

Main研究棟本館
research building

Washing
洗浄室
room

Study
related zone
試験関連区域

GLP zone
ＧＬＰ区域(a) Study operation zone
Microbial laboratory
Incubator
インキュベーター

冷蔵庫

冷蔵庫

Workbench
操作台

Colony counter
コロニーカウンター
Microscope
顕微鏡(b) Test and reference items handling zone……

- 20 -

ＰＣ

(2) Circulation diagram
Prepare diagrams describing items 1) to 6).
1) Circulation of animals, from carrying-in and carrying-out (including dissection room)2) Carry-in and -out routes of animal feed (basic feed), equipment, etc.
3) Carry-out route of waste (sewage) from the animal housing room4) Route for human entrance into and exit from the animal housing room5) Circulation of test items (or mixture) and positive reference items
6) Flow of waste (including wastewater)*1 Make the diagrams comprehensible, e.g., in different colors.
*2 Clearly indicate the boundaries of barrier animal rooms, e.g., in bold lines.
*3 For item 4), prepare separate diagrams for clean operation and dirty operation.
*4 Prepare diagrams describing items 1) to 4) for animal housing zones (including any relevant facility other than
the animal housing zones).

- 21 -

(Example) Route of human entrance into and exit from the animal housing room

クリーン準備室

Ｃ－Ｃ
Anter

Anteroom

前室

ＡＣ

ＲＷ

★

Anteroom

前室 ★ 前室Anteroom

★

★

oom
前室

ＣＥＶ
Rats
ラット

ＡＳ

Rats
ラット

ＰＢ

Rats
ラット

ラット
Rats

洗浄室
Washing
room
ラット
Rats

ラット
Rats

観察室
Back
観察室 Backroom
Observation Observation
後室
Backroom Backroom 後室
観察室
後室
後室
room room
room
room

Test item preparation room

Rats
ラット

被
験
物
質
調
整
室

ＰＲ

Ｄ－Ｃ

更衣
前室
room

Corridor廊下: Barrier housing facility

ＤＥＶ: Test/reference items handling facility AS: air shower

RW: rack washer
AC: autoclave★: Changing into dust-free garments and special footwear for animal housing rooms PR: pass room
(undressing, shower,: Route of entrance into barrier animal facility
dressing）: Route of exit from barrier animal facility
CEV: clean elevator
DEV: dirty elevator: Route of entrance and exit for dirty operation
C-C: clean corridor
D-C: dirty corridor
PB: pass box: Dirty operation zone(3) Air conditioning diagram
Prepare 1) and 2).
1) Schematic diagram of air conditioning in the facility2) Schematic diagram of air flow in barrier system*1 Make the diagrams comprehensible, e.g., in different colors.
*2 Specify the type of air filters.
*3 Locate any heat exchange performed by air supply and evacuation.
*4 Locate air supply and exhaust openings.
- 22 -

(Example) Schematic diagram of air conditioning in the facility

クリーン準備室

Ｃ－Ｃ
Anteroom

前室

前室

Anter
oom

前室

前室

Anteroom

ＲＷ

ＣＥＶ
ラット
Rats

ラット
Rats

Rats
ラット
Rats
ラット

ＡＳ
Rats
ラット

洗浄室room
Washing
Rats
ラット

ラット
Rats

Observation
観察室 Observation
観察室
Back room
Back 観察室
room
room
room
後室
Back
room
Back
room
後室
後室
後室
room

ＰＢ
Test item preparation room

ＡＣ

Anteroom

被
験
物
質
調
整
室

ＰＲ

Ｄ－Ｃ

更衣

Corridor廊下: Barrier housing facility: Test/reference items handling facility: Dirty operation zone
:

ＤＥＶ

room
前室

Air flow○: Air supply opening●: Exhaust opening- 23 -

AS: air shower
RW: rack washer
AC: autoclave
PR: pass room (undressing,shower, dressing)
CEV: clean elevator
DEV: dirty elevator
C-C: clean corridor
D-C: dirty corridor
PB: pass box

18 Handling and Disposal of Waste
Describe the handling and disposal of waste.
(Example)(1) Animal carcasses
1 Packed in a plastic bag inside an exclusive container that is sealed and temporarily stored in a freezer
2 Regularly (once a week) collected by waste disposal services (×× Co., Ltd., ○○ governor approval no.××)
3 Transported by waste disposal services via ○○, incinerated at ×× and buried in □□(2) Disposal of wastewater, etc.
………

19 Names, Quantities, Models, and Other Related Information of Major Apparatus used for Studies(Types and Nature of Apparatus)
Specify the names, quantities, manufacturers, models, etc. of major apparatus and equipment used for the study for
individual installation sites.
* Also include major computers used for analyzing study data and major equipment, etc. used for controlling
facility environment.
* Indicate the magnification of microscopes and reading accuracy of scales in the remarks column.
(Example)
Installation
site

Name

Quantity Manufacturer

Model(Purchase date)

Remarks

○○

○○

1

○○

○○-○○

○/○/○

○○○○

･･･

･･･

･･･

･･･

･･･

･･･

･･･

- 24 -

20 Status of Animal Housing Facility(1) Housing conditions
Specify the temperature, water temperature (for fish), humidity, light (illumination intensity), lighting hours,
noise, cleanliness (dust, microbes, etc.), ventilation frequency, differential pressure, etc. Separately indicate each if
the conditions differ between the barrier and conventional areas.
(Example)
Item

Barrier area

Temperature

Conventional area

Management criteria

21-25°C

Tolerance level20-26°C

Humidity

Management criteria

45-65%(relative humidity)

Tolerance level35-75%Light

Management criteria

350 lux or higher

Noise

Management criteria

55dB or lower

Cleanliness

Management criteria(illumination intensity)
4 colonies or less/plate

40 colonies or less/plate(airborne bacteria)
Differential pressureManagement criteria

Ventilation frequency

Management criteria

1 mmH2O or higher
20 times or more/hour

Tolerance level

15 times or more/hour

12 times or more/hour(2) Supplier of analysis data and frequency of analysis on feed, water, and beddingSpecify each for type of feed, water, and bedding.
(Example)
Feed

Nutritional analysis (obtained from the supplier, per lot)
Trace toxic substance analysis (obtained from the supplier, analyzed per lot)
Microbial examination (obtained from the supplier, analyzed per lot, conducted here once every year)

Water

Water examination (commissioned, ○ times per year)

Bedding Trace toxic substance analysis (obtained from the supplier, once about every ○ months)(3) Status of microbial monitoring in animal housing rooms and other related information
If microbial monitoring such as airborne bacteria count, etc. is conducted, specify the measurement sites (indicate theposition of petri dishes as ●) using the floor plan of the animal housing room, and describe the overall condition
including measurement frequency, criteria, etc.

- 25 -

21 Environmental Control, Monitoring Procedures, and Other Related Information of Important Zones
For important zones specified in 1) to 5) where temperature, humidity, differential pressure, etc. are controlled,
describe the methods of environmental control and monitoring and measures taken in the event of problems.
1) Animal housing zone
2) Animal supplies storage zone
3) Test items, etc. storage zone4) Study operation zone5) Special study zones including chemo (chemical hazard) and biohazard containment zones* For describing the measures taken in the event of problems, refer to the facility regulation and SOP and include
the following points:･ Contact from individual(s) who found the problem (How can the problems be detected? Monitoring system, etc.)･ By what means and to whom is the problem reported? (emergency contact system (network), etc.)･ Who judges the report received? Who takes actual measures? Etc.
(Example)
A central monitoring apparatus for the air conditioning system is installed in the central control room. The
apparatus monitors and controls the temperature and humidity around-the-clock in the animal housing room,archive room, and low-temperature laboratory.
Any problem in ○○ is ･･･ by the central control room

- 26 -

22 Status of Washing, Disinfection, and Other Related Information(1) Use of detergents and disinfectants
Describe the use of detergents and disinfectants for each category.
Describe the washing and disinfection procedures.
(Example)

Category

Item Replacement
frequency(/week)Washing

Disinfection

Sterilizationa) Cageb) Feederc) Water bottled) Countere) Hutchf) Case card(label holder)g) Automatic
feederh) Automaticwatereri) Water tankj) Feed container(in animal
housing room)k) Floorl) Ceilingm) Walln) Drainageo) Lamp(2) Use of pest control agents
Describe the use of pest control agents.
(Example)
Used once a year for every floor. Last used on year○month○day○.

- 27 -

Cleaning

Rinsing after
disinfection

23 Animals and Care of Animals(1) Methods of receipt, quarantine, and care of animals
Briefly describe 1) to 6). They may be described separately for individual animal species.
1) Information concerning received animals (producers (in-house production, commission, production agency, etc.),
animal types (SPF animals, germ-free animals, etc.), use of vaccines, pest control agents, antifoulants and otherdrugs on received animals, availability of records of microbial monitoring, transport and receipt of animals)
2) Receiving animals
3) Receiving inspection (implementation of quantity check, sex check, body weight measurement and appearance
check, presence or absence of records)
4) Quarantine, acclimatization (period of quarantine or acclimatization, items examined in microbial examination(protozoa, parasites, bacteria, etc.), implementation of clinical examination, qualification of personnel
responsible for evaluating health condition, records concerning animal care (findings of microbial examination,body weight measurements, etc.))
5) Care methods
6) Use of vaccines, pest control agents, insecticides, antifoulants and other drugs on animals(Example)[Rats]
1 Information concerning received animals･Producer of received animals

Production agency･Type of received animals

SPF animals･Use of drugs on received animals

Not used･Microbial monitoring records

Available･Records of transport of received animals

Not available･Receipt records
2 Receiving animals

Available
Separate rooms are used for receipt, quarantine and housing

3 Receiving inspection･Quantity check

Conducted･Sex check

Conducted･Body weight measurement Conducted･Appearance check

Conducted･Records

Available

4 Quarantine, acclimatization･Period of quarantine or acclimatization○○days･Items examined in microbial examination

Parasites, bacteria, virus･Clinical examination

Not conducted･Qualification of personnel responsible for evaluating health condition
Personnel responsible for care of animals (veterinarian)･Records concerning care of animals
Findings of general observation of symptoms, body weight measurements
5 Care methods

Barrier system

6 Use of drugs on animals

Not used- 28 -

(2) Handling of diseases or conditions
If any, briefly describe the regulations concerning the handling of diseases or conditions.
Specify 1) to 5) for each case of disease or condition handled after the previous inspection (investigation) (or in thepast if this is the first time to receive the inspection (investigation)).
1) Date of occurrence2) Species and strain of the relevant animal3) Type of study in which the relevant animal was used
4) Situation of occurrence(1) Observed in ○○ out of ○○ animals (or observed in ○○ out of ○○ monitored animals)(2) Observed on ○○ days after initiation of administration in a ○○-day administration study, or observed inmonitored animals on ○○ days after initiation of administration(3) Circumstances of the detection of the disease (detected through monitor examination, general observation,etc.)(4) Conduct of any other study in the same housing room(5) Conduct of any other study in the same housing zone5) Measures taken(1) Examination and treatment of the diseased animals(2) Checking of infection of other animals in the same housing room or zone
(3) Continuation or withdrawal of the studies mentioned in 4) (4) or (5)Quality assurance of the studies continued(4) Recording the above matters in the raw data (rearing records, records of general condition examination,etc.), documentation, and filing of these matters(5) Notification of the above matters in the final report, in the case where the relevant study was continued(Example)In the case where any disease or condition is detected, record that state in a specified format and report the caseto the Study Director. Following the instructions of the Study Director, isolate or destroy the animal in the isolation
room.
If the animal is to be destroyed, euthanize the animal with approval of the Study Director, and document and filethe case in a specified format.
(3) Management of feed, water, animal care instrument, detergents, and other related information
Briefly describe items 1) to 5) concerning the management of feed, water, animal care instrument, detergents, andother related information.
1) Acceptable levels of feed and water(whether acceptable levels are defined)
2) Feed(manufacturer, type of feed (for individual species), form of feed, site of analysis, storage condition of feed,
presence or absence of records)
3) Water(availability of tap water specified in the Water Supply Law, availability of in-house pumping and water
receiving tank, types of toxic metal removal apparatus, disinfection apparatus and sterilizer, implementation of
microbial monitoring of watering bottles, replacement frequency of watering equipment such as watering bottles,
etc., site of analysis, presence or absence of records)
4) Animal care equipment, instruments- 29 -

(availability of facilities for washing, disinfecting, and sterilizing the equipment and instruments for animal care,storage method of care equipment and instruments)
5) Use of detergents or insecticides affecting the study after the previous inspection (or investigation)(if used, presence or absence of instruction from the Study Director, purpose of use, type of detergent or
insecticide used, range of use, method of use, the amount used, and presence or absence of records)(Example)1) Acceptable levels of feed and water
Defined in SOP ○○○○.
2) Feed(rats, mice)
Manufacturer

Japan ○○ Co., Ltd.

Type of feed

CEA-2

Form of feed

Solid powder･Site of analysis

Analysis results obtained from the manufacturer･Storage condition of feed

Same as that for housing animals. Stored for 6 months after the datemanufactured.

･Records

Available

3) Water･Tap water specified in the Water Supply Law

Available･In-house pumping

Not available･Water receiving tank

Available･Type of toxic metal removal apparatus

Not available･Type of disinfection apparatus or sterilizer

5μm membrane filter･Microbial monitoring of watering bottles

Not conducted･Replacement frequency of watering equipment, e.g. watering, bottles, etc.

Every ○ months･Site of analysis

Commissioned to ○○ Testing Laboratory･Records

Available

4) Animal care equipment, instrument･Care equipment and instrument

Washing facility, sterilization facility･Storage method of equipment and instrument

Stored in instrument storage

5) Use of detergents or insecticides affecting the study
None

24 Master Schedule
Attach a copy of the master schedule for the month in which the document was prepared or the previous month.

- 30 -

25 Standard Operating Procedures (SOPs)(1) SOPs and formats, and other related information specified in SOPs
Submit a copy each of SOPs concerning the following procedures, and formats specified in the SOPs.
1) Preparation of the study plan (including an example format)
2) Preparation of the final report (including an example format)3) Conduct of the study, judgment of the results, measures taken when abnormal levels are observed4) Storage of samples and materials(2) Procedures for preparation, revision, disposal, and other related information of SOPs
(Example)
1. SOP preparation
SOP is…, and approved (prepared) by the test facility management.
2. SOP revision
Any personnel who considered that SOP needs to be revised....
3. SOP disposal
Any personnel who considered that SOP is no longer necessary....
(3) List of titles in SOPs
* Prepare a list of the total number, the serial numbers (symbols) and titles of SOPs.
If any, describe the rules for assigning serial numbers (symbols) to SOPs.
(Example)
In accordance with the following comprehensive list, serial numbers are added to the end of the SOP numbers.
SOP comprehensive list
SOP/SOP/000

Standard Operating Procedures

SOP/QAU/000

Quality Assurance Unit (QAU)

SOP/REP/000

Final Report･･･
List of titles
Standard Operating Procedures
SOP/SOP/001

Preparation of Standard Operating Procedures

SOP/SOP/002

Format of Standard Operating Procedures

Quality Assurance Unit (QAU)
SOP/QAU/001

Work content of Quality Assurance Unit (QAU)･･･- 31 -

26 Flow Chart of Safety (Toxicity) Studies
Prepare a flow chart of the study, 1) to 8), etc., from the planning phase to the completion of the study.
1) Interaction with the sponsor(1) Request of study from the sponsor(2) Approval of the study plan by the sponsor(3) Submission of the final report to the sponsor
2) Test facility management(1) Appointment of the Study Director and the Quality Assurance Unit manager(2) Preparation of SOPs
(3) Approval or confirmation of the study plan(4) Submission of the final report by the Study Director3) Quality Assurance Unit (QAU)(1) Appointment of Quality Assurance Unit personnel in charge of individual studies(2) Submission of improvement recommendation and investigation report to the test facility management(3) Submission of improvement recommendation and investigation report to the Study Director
4) Flow of the study(1) Preparation of the study plan(2) Signature by the Study Director(3) Approval or confirmation by the test facility management (including the sponsor), investigation by Quality
Assurance Unit, etc.
5) Flow of the test item, reference item
(1) Request of analysis(2) Conduct of analysis(3) Receipt of analysis records(4) Order placement, receipt, storage and return of the test and reference items
6) Final report(1) Signing by the Study Director(2) Investigation by Quality Assurance Unit
7) Flow of stored documents
8) Others- 32 -

(Example) Flow chart of a safety (toxicity, etc.) study
Request of study by sponsor
委託者より試験委託

Appointment of Study Director(s), Quality Assurance Unit manager and試験責任者・信頼性保証部門・被験物質管理者の指定
personnel responsible for the management of test and reference item
Preparation of study plan
試験計画書の策定
Consideration of test item(s)被験物質に係る検討

Approval by test facility
運営管理者の承認
management
Approval by sponsor
委託者の承認

試験実施

調製

Designingof study plots
群構成

被験物質の投与
経過観察・各種測定
動物解剖
標本作製
Histopathologicalexamination
病理組織学的検査

Storage of test item(s)
被験物質の保管

Data
processing
データ処理

Storage of raw data
生データの保存Preparation of final
最終報告書作成

Implementation of inspection
信頼性保証部門by Quality Assurance Unit
（ＱＡＵ）査察実施(QAU)

Submission of final
最終報告書提出- 33 -

27 Overview of Computerized System
In the case where computerized systems are used for processing study data, describe the purpose of their use (datacollection, preparation of figures and tables attached to the final report, statistical calculation, etc.) and how they areused. In addition, provide the definition of raw data and the methods of modification and correction of the raw data.
Describe the use of computerized system by specifying the following items 1) to 5), regardless of the definition of
the raw data.
1) Pattern of computer use2) Name and developer of the system
3) For a commercial system partially modified after purchase, which part(s) were modified and how modified
4) System configuration
5) Method and frequency of system validation(1) Parts of the study where the computer is used
Identify where the computer is used using the flow chart of the safety (toxicity, etc.) study.
(2) Hardware configuration
Identify the host computer, LAN, data collection terminals, connected device, etc.
(3) System configuration
Describe the system performance and the target study, examination, etc.
(Example)1) On-line computer system<Housing
room>
＜飼育室＞
Experimental datacollection
and air
実験データ収集
conditioning
control
及び空調管理ホストコンピューター
Hostcomputer
試験スケ
Study
ジュール
schedule
管理management

データベースサーバー
Database server<Autopsyroom>＜解剖・献体室＞＜各部所＞<Individual
units>

Variousmeasurement
各種測定機器末端
apparatus terminals

試験責任者ＰＣ
Study
Director's PC＜ＱＡＵ室＞<QAU room>

QAU
ＱＡＵ検索末端
retrieval terminal

2) Stand-alone computer(1) ○○ measurement system: ××× manufactured by ○○. Used for weighing test animals for ○○ study. Installedin year○ in room ○○････.

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28 Status of Outsourcing of Studies
Provide a flow chart illustrating the procedures of commission (delivery of specimens, handling of test items, etc.,
QAU investigation, etc.). In the case where studies are commissioned to more than one entity, prepare a flow chart
for a representative entity.
(Example)1) Commission of the entire study

社外委託決定Confidentiality
秘密保持契約書
agreements
見積書
Costestimate
契約書
Contract

Study plan (draft)
試験計画書（案）Decision of commission of safety study
安全性試験委託決定及び委託
andnotification of appointment tocommissioned
entity先選定通知書Inspection of facility by personnel in
委託試験担当者（技術責任者）
chargeof the commissioned study(technical
及びQAUによる施設の視察
manager) and QAU
Request of preparation of study plan
試験計画書（案）作成依頼(draft)Technical
consideration
技術的検討
Revised study plan draft
試験計画書案改訂版
Personnel in charge of the commissioned

委託試験担当者（技術責任者）
study (technical manager)
Study plan
試験計画書

運営管理者署名捺印Order発注
placement
Supplyof test item(s)被験物質提供Conductof study
試験実施

Inspectionof study operation by personnel
委託試験担当者（技術責任者）
incharge of the commissioned study
及びQAUによる試験操作の(technical manager) and QAU

視察

Interim report
中間報告書
Examination
by personnel in charge of the
委託試験担当者（技術責任者）
commissioned study (technical manager)の検討

Final report (draft)
最終報告書（案）

委託先
Commissioned
entityFinal report
最終報告書- 35 -

Examination
by personnel in charge of the
委託試験担当者（技術責任者）
commissionedの検討 study (technical manager)
Inspection by QAUQAUの査察2) Commission of some of the study items
Decision of in-house conduct

主試験の社内実施決定
of main study

Study Director, personnel 担当責任in charge of
試験責任者，検査
investigation: Discussion about

practicability of in-house conduct of
者：試験項目の社内実施の可Confirmationof contents by
運営管理者，ＱＡＵに
test facility management andQAU
よる内容の確認

study items

否を協議
Preparation of request of partial
Decision of
一部試験項目のcommission of somestudy items
社外委託決定Confidentiality
秘密保持契約書
agreements
見積書
Cost estimate
契約書
Contract

Study plan (draft)
試験計画書（案）

commission of in-house study

社内試験一部委託要請書作成
Documentationof commission of
主試験の試験計画書に当該
relevant study items in study plan of
試験項目を社外委託する旨
the main study. Submission of report
明記。試験計画書の承認後
ofchange(s) in study plan, if
commission
is decided after approvalに決定した場合は、試験計
ofthe study plan.
画変更書により変更

更書を作成。
検査担当責任者及びＱＡＵによる
Inspection of facility by personnel in charge
技術責任者及びQAU の査察
of investigation and QAU
施設の視察
試験計画書（案）作成依頼
Requestof preparation of study plan (draft)
試験計画書(案)作成依頼
技術的検討

Revised study plan draft
試験計画書案改訂版

検査担当責任者確認
試験計画書
Study plan
運営管理者署名捺印Order発注
placement
Delivery of test item(s)試験試料の送付

試験実施
Conductof study

Inspection of study operation by
検査担当責任者及びQAUによpersonnel in charge of investigation

る試験操作の視察
and QAU
記録，生データ
Records, raw data
Specimens
標本類
Final report (draft)
最終報告書（案）

委託先
Commissioned
entity記録，生データ
Records, raw data
Specimens
標本類
Final
report
最終報告書

Incorporation
into main study
主試験に組み入れ- 36 -

ation by personnel in charge of
検査担当責任者の検討
investigation
ＱＡＵの査察Inspection by QAU

29 Multi-site Studies
Among the studies inspected (investigated) and the studies conducted over the last three years, for those conducted
at more than one testing facility, specify the title of the study, name of the collaborating testing facility/facilities, content
of the study, content of the sharing of study work and names and affiliations of test facility general management andgeneral study director.
Write accordingly if test facility general management and general study director were not appointed.
(Example)year○

Title of study

Collaborating
testingfacility/facilities

Content of study

Content ofsharing of study
work

Test facility
generalmanagement(name, affiliation)

General study
director(name,
affiliation)

30 Problems Found in Past GLP Inspections (Investigations) and Status of Improvement
Write any problems found in the relevant GLP inspection (investigation) conducted in the past. Specify the statusof improvement for each problem.

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