Regulation on Designation and Management Standards for Test Facility
Ministry of Environment Public Notice No. 2022-9
Partially amended and enforced on January 11, 2022

Article 1 (Purpose)
The purpose of this Public Notice is to provide regulations concerning the designation andmanagement, etc of test facilities in accordance with Article 22 of「Act on Registration」 (hereinafter called Act), Article 17 of theand Evaluation of Chemical Substances, etc.

Enforcement Decree of the Act (hereinafter called Decree), Articles 29 (5) and 30 (4) of the
Enforcement Rule of the Act (hereinafter called Rule).

Article 2 (Definitions of Terms)
The definitions of terms used in here are as follows:
1. “Test facility” means the persons, premises and operational unit(s) that are necessary for
conducting the non-clinical health and environmental safety study under Article 22 of the
Act and Article 17 of the Decree.
2. "Study of physical and chemical properties and hazards of chemical substances" means
tests conducted in laboratory conditions, greenhouses or outdoors to determine the physicalor chemical properties of test substances and their safety for human health and/or theenvironment.
3. “Principles of Good Laboratory Practice” (hereinafter called “GLP Principles”) mean theprinciples which stipulate collective matters concerned with the organizational process andthe conditions under which laboratory studies are planned, performed, inspected, recorded,
and reported, which is based on the OECD GLP.
4. “Multi-site studies” mean the studies which are conducted at more than one site. For
multi-site studies, the test facility comprises the site at which the Study Director is located andall individual test sites, which individually or collectively can be considered to be test facilities.

Article 3 (Criteria for Designation and Management)
Designation and/or change of designation of a test facility and criteria for a test facility
management pursuant for Articles 22, 29 (5), and Article 30 (4) of the Act shall comply
with Annex 1 (“Principles on GLP”) and Annex 5 (“Multi-Site Study”).

Article 4 (Designation and Inspection)
1. The procedure of designating or changing the designation of a test facility under Article
22 (1) of the Act is as shown in Annex 2 (“Procedure for Designation and/or Changes to
Designation of GLP facility”).
2. The Minister of Environment shall notify the President of the National Institute ofEnvironmental Research of the case where there is an application for designation or change
of designating the test facility in accordance with Article 22 (2) of the Act.
3. The President of the National Institute of Environmental Research shall evaluate a test
facility applying for the designation in accordance with Annex 3 (“Test Facility Inspectionand Study Audit”), and submit the results thereof to the Minister of Environment.

Article 5 (Mutual Recognition)
The Minister of Environment may mutually recognize an institution falling under any of thefollowing subparagraphs as a test facility designated by this public notice. In this case,matters deemed necessary may be requested from relevant ministries.
1. An organization designated as a test facility under Korea's Pharmaceutical Affairs Act,
Cosmetics Act, Medical Devices Act or Pesticide Control Act in compliance with GLP.
2. Test facilities in OECD member countries that comply with the OECD GLP, or in
non-member countries recognized by member countries as being compliant.

Article 6 (Periodic Inspection)
1. The President of the National Institute of Environmental Research shall evaluate the test
facilities designated under Article 22 of the Act periodically every two years in accordancewith Annex 3 (“Test Facility Inspection and Study Audit”), and submit the results thereof to
the Minister of Environment. However, periodic inspections may be conducted in parallelwith study audit or on-site inspections resulted from changes to test scope, etc.
2. The President of the National Institute of Environmental Research may conduct a study
audit to verify the reliability of the results of tests conducted by designated test facilities inaccordance with Article 22 of the Act.
3. The President of the National Institute of Environmental Research may systematicallyevaluate a test facility and a test site to confirm the operation or reliability of multi-site
study.
4. Details such as periodic inspection and study audit procedure in accordance withparagraphs 1 to 3 shall be conducted in accordance with the regulation on inspection andstudy audit of a test facility in Annex 3.

Article 7 (Inspection Team)
1. The President of the National Institute of Environmental Research shall form aninspection team (hereinafter called “inspection team”) to efficiently perform evaluation tasks
regarding criteria for designation and management of a test facility.
2. Details necessary for the composition and operation of the inspection team under theparagraph 1 are as shown in Annex 4 (“Composition and Operation of Inspection Team”).

Article 8 (Test Guidelines)
When a test facility produces test data in accordance with Article 14 (1) 5 and 6 of theAct, the test method notified by the President of the National Institute of Environmental
Research in accordance with Article 8 of Annex 1 under Article 5 (1) 1 of the Rule shallbe used. However, internationally recognized test methods, such as OECD Guidelines for the
Testing of Chemicals, may be recognized as published test methods.

Article 9 (Term of Review)
The Minister of Environment shall review legal validity of this public notice every three
years as of January 1, 2022 (referring to June 30 of every third year) and take measures
such as amendment.

Addendum < No. 2022-9, Jan. 11, 2022 > This Public Notice shall come into effectenforce from the date of issuance.

Annexes
Annex 1 : Principles of Good Laboratory Practice (related to Article 3 of the Regulation)
Annex 2 : Procedure for Designation and/or Changes to Designation of GLP facility(Related to Article 4 of the Regulation)
Annex 3 : Test Facility Inspection and Study Audit (Related to Article 4 of the Regulation)
Annex 4 : Composition and Operation of Inspection Team (Related to 7 of the Regulation)
Annex 5 : Multi-site Study (Related to Article 3 of the Regulation)

Annex 1. Principles of Good Laboratory Practice (related to Article 3 of the Regulation): Adopted “Document No. 1 of the OECD Series on the Principles of GLP Compliance Monitoring”
Article 1 (Purpose)
This regulation aims to define the quality system concerned with the organisational process
and the conditions under which non-clinical health and environmental safety studies areplanned, performed, monitored, recorded, archived at the facility under Article 3 and theoverall matters related thereto.
Article 2 (Scope)
These Principles of Good Laboratory Practice should be applied to the non-clinical safety
testing of test items contained in pharmaceutical products, pesticide products, cosmetic
products, veterinary drugs as well as food additives, feed additives, and industrial chemicals.
These test items are frequently synthetic chemicals, but may be of natural or biological origin
and, in some circumstances, may be living organisms. In this case the test is mainly carriedout in a laboratory but may be carried out in a greenhoue and in the field.
Article 3 (Definitions of Terms)
1. Good Laboratory Practice (GLP) is a quality system concerned with the organisational
process and the conditions under which non-clinical health and environmental safety studies
are planned, performed, monitored, recorded, archived and reported.
2. Terms Concerning the Organisation of a Test Facility
1) “Test facility” means the persons, premises and operational unit(s) that are necessary
for conducting the non-clinical health and environmental safety study.
2) “Test site” means the location(s) at which a phase(s) of a study is conducted
3) “Test facility management” means the person(s) who has the authority and formal
responsibility for the organisation and functioning of the test facility according to these
Principles of Good Laboratory Practice.
4) “Test site management” (if appointed) means the person(s) responsible for ensuringthat the phase(s) of the study, for which he is responsible, are conducted according tothese Principles of Good Laboratory Practice.
5) “Sponsor” means an entity which commissions, supports and/or submits a non-clinicalhealth and environmental safety study.
6) “Study Director” means the individual responsible for the overall conduct of thenonclinical health and environmental safety study.
7) “Principal investigator” means an individual who, for a multi-site study, acts on behalfof the Study Director and has defined responsibility for delegated phases of the study.
The Study Director's responsibility for the overall conduct of the study cannot bedelegated to the Principal investigator(s); this includes approval of the study plan and its
amendments, approval of the final report, and ensuring that all applicable Principles ofGood Laboratory Practice are followed.
8) “Quality Assurance Program” means overall matters related to studies and test facilities
a defined system, including personnel, which is independent of study conduct and isdesigned to assure test facility management of compliance with these Principles of Good
Laboratory Practice.
9) “Standard Operating Procedures (SOPs)” means documented procedures which describe
how to perform tests or activities normally not specified in detail in study plans or test
guidelines.
10) “Master schedule” means a compilation of information to assist in the assessment ofworkload and for the tracking of studies at a test facility.
3. Terms Concerning the Non-Clinical Health and Environmental Safety Study
1) “Non-clinical health and environmental safety study”, henceforth referred to simply as"study", means an experiment or set of experiments in which a test item is examined
under laboratory conditions or in the environment to obtain data on its properties and/or
its safety, intended for submission to appropriate regulatory authorities.
2) “Study plan” means a document which defines the objectives and experimental designfor the conduct of the study, and includes any amendments.
3) “Study plan amendment” means an intended change to the study plan after the study
initiation date.
4) “Study plan deviation” means an unintended departure from the study plan after the
study initiation date.
5) “Test system” means any biological, chemical or physical system or a combination
thereof used in a study.
6) “Raw data” means all original test facility records and documentation, or verified
copies thereof, which are the result of the original observations and activities in a study.
Raw data also may include, for example, photographs, microfilm or microfiche copies,

computer readable media, dictated observations, recorded data from automated instruments,
or any other data storage medium that has been recognized as capable of providing
secure storage of information for a time period.
7) “Specimen” means any material derived from a test system for examination, analysis,or retention.
8) “Study initiation date” means the date the Study Director signs the study plan.
9) “Experimental starting date” means the date on which the first study specific data arecollected.
10) “Experimental completion date” means the last date on which data are collected fromthe study.
11) “Study completion date” means the date the Study Director signs the final report.
4. Terms Concerning Test Items
1) “Test item” means an article that is the subject of a study.
2) “Reference item (control item)” means any article used to provide a basis forcomparison with the test item.
3) “Batch” means a specific quantity or lot of a test item or reference item produced
during a defined cycle of manufacture in such a way that it could be expected to be ofa uniform character and should be designated as such.
4) “Vehicle” means any agent which serves as a carrier used to mix, disperse, or
solubilize the test item or reference item to facilitate the administration/application to thetest system.
Article 4 (Test Facility Organisation and Personnel)
1. Test Facility Management's Responsibilities:
1) Each test facility management should ensure that these Principles of Good Laboratory
Practice are complied with, in its test facility.
2) At a minimum it should:
a. ensure that a statement exists which identifies the individual(s) within a test facility
who fulfill the responsibilities of management as defined by these Principles of Good
Laboratory Practice;b. ensure that a sufficient number of qualified personnel, appropriate facilities,
equipment, and materials are available for the timely and proper conduct of the study;c. ensure the maintenance of a record of the qualifications, training, experience andjob description for each professional and technical individual;d. ensure that personnel clearly understand the functions they are to perform and,
where necessary, provide training for these functions;e. ensure that appropriate and technically valid Standard Operating Procedures are
established and followed, and approve all original, revised and scrapped Standard
Operating Procedures;
f. ensure that there is a Quality Assurance Program with designated personnel andassure that the quality assurance responsibility is being performed in accordance withthese Principles of Good Laboratory Practice;g. ensure that for each study an individual with the appropriate qualifications, training,and experience is designated by the management as the Study Director before thestudy is initiated. Replacement of a Study Director should be done according toestablished procedures, and should be documented.
h. ensure, in the event of a multi-site study, that, if needed, a Principal investigator isdesignated, who is appropriately trained, qualified and experienced to supervise thedelegated phase(s) of the study. Replacement of a Principal investigator should bedone according to established procedures, and should be documented.
I. ensure documented approval of the study plan by the Study Director;
j. ensure that the Study Director has made the approved study plan available to the
Quality Assurance personnel;
k. ensure the maintenance of an historical file of all Standard Operating Procedures;
l. ensure that an individual is identified as responsible for the management of thearchive(s);m. ensure the maintenance of a master schedule;n. ensure that test facility supplies meet requirements appropriate to their use in astudy;
o. ensure for a multi-site study that clear lines of communication exist between the
Study Director, Principal investigator(s), the Quality Assurance Program(s) and study
personnel;
p. ensure that test and reference items are appropriately characterized;
q. establish procedures to ensure that computerized systems are suitable for theirintended purpose, and are validated, operated and maintained in accordance with thesePrinciples of Good Laboratory Practice.
r. When a phase(s) of a study is conducted at a test site, test site management (ifappointed) will have the responsibilities as defined above with the following
exceptions: 1.1.2 g), i), j) and o).
2 Study Director's Responsibilities
1) Study Director is the single point of study control and has the responsibility for theoverall conduct of the study and for its final report.
2) These responsibilities should include, but not be limited to, the following functions.
The Study Director should:
a. approve the study plan and any amendments to the study plan by dated signature;b. ensure that the Quality Assurance personnel have a copy of the study plan and any
amendments in a timely manner and communicate effectively with the Quality
Assurance personnel as required during the conduct of the study;c. ensure that study plans and amendments and Standard Operating Procedures areavailable to study personnel;
d. ensure that the study plan and the final report for a multi-site study identify anddefine the role of any Principal investigator(s) and any test facilities and test sites
involved in the conduct of the study;e. ensure that the procedures specified in the study plan are followed, and assess anddocument the impact of any deviations from the study plan on the quality and integrityof the study, and take appropriate corrective action if necessary; acknowledge deviations
from Standard Operating Procedures during the conduct of the study;
f. ensure that all raw data generated are fully documented and recorded;
g. ensure that computerized systems used in the study have been validated;h. sign and date the final report to indicate acceptance of responsibility for the validityof the data and to indicate the extent to which the study complies with these
Principles of Good Laboratory Practice;I. ensure that after completion (including termination) of the study, the study plan, thefinal report, raw data and supporting material are archived.
3. Principal investigator's Responsibilities. The Principal investigator will ensure that thedelegated phases of the study are conducted in accordance with the applicable Principles
of Good Laboratory Practice.

4. Study Personnel's Responsibilities.
1) All personnel involved in the conduct of the study must be knowledgeable in thoseparts of the Principles of Good Laboratory Practice which are applicable to theirinvolvement in the study.
2) Study personnel will have access to the study plan and appropriate Standard Operating
Procedures applicable to their involvement in the study. It is their responsibility tocomply with the instructions given in these documents. Any deviation from these
instructions should be documented and communicated directly to the Study Director,
and/or if appropriate, the Principal investigator(s).
3) All study personnel are responsible for recording raw data promptly and accurately
and in compliance with these Principles of Good Laboratory Practice, and are responsible
for the quality of their data.
4) Study personnel should exercise health precautions to minimize risk to themselves andto ensure the integrity of the study. They should communicate to the appropriate person
any relevant known health or medical condition in order that they can be excluded fromoperations that may affect the study.
Article 5 (Quality Assurance Program)
1. General Matters1) The test facility should have a documented Quality Assurance Program to assure thatstudies performed are in compliance with these Principles of Good Laboratory Practice.
2) The Quality Assurance Program should be carried out by an individual or byindividual(s) designated by and directly responsible to management and who are familiar
with the test procedures.
3) This individual(s) should not be involved in the conduct of the study being assured.
2. Responsibilities of the Quality Assurance Personnel
1) The responsibilities of the Quality Assurance personnel include, but are not limited to,the following functions. They should:
a. maintain copies of all approved study plans and Standard Operating Procedures in use
in the test facility and have access to an up-to-date copy of the master schedule;b. verify that the study plan contains the information required for compliance with these
Principles of Good Laboratory Practice. This verification should be documented;
c. conduct inspections to determine if all studies are conducted in accordance with thesePrinciples of Good Laboratory Practice. Inspections should also determine that study
plans and Standard Operating Procedures have been made available to study personnel
and are being followed.
Inspections can be of three types as specified by Quality Assurance Program Standard
Operating Procedures:- Study-based inspections,- Facility-based inspections,- Process-based inspections.
Records of such inspections should be retained.
d. inspect the final reports to confirm that the methods, procedures, and observations areaccurately and completely described, and that the reported results accurately andcompletely reflect the raw data of the studies;e. promptly report any inspection results in writing to management and to the Study
Director, and to the Principal investigator(s) and the respective management, whenapplicable;
f. prepare and sign a statement, to be included with the final report, which specifies
types of inspections and their dates, including the phase(s) of the study inspected, andthe dates inspection results were reported to management and the Study Director andPrincipal investigator(s), if applicable. This statement would also serve to confirm thatthe final report reflects the raw data.
Article 6 (Facilities)
1. General Matters1) The test facility should be of suitable size, construction and location to meet therequirements of the study and to minimize disturbance that would interfere with thevalidity of the study.
2) The design of the test facility should provide an adequate degree of separation of thedifferent activities to assure the proper conduct of each study.
2. Test System Facilities
1) The test facility should have a sufficient number of rooms or areas to assure theisolation of test systems and the isolation of individual projects, involving substances ororganisms known to be or suspected of being biohazardous.
2) Suitable rooms or areas should be available for the diagnosis, treatment and control ofdiseases, in order to ensure that there is no unacceptable degree of deterioration of test
systems.
3) There should be storage rooms or areas as needed for supplies and equipment. Storage
rooms or areas should be separated from rooms or areas housing the test systems andshould provide adequate protection against infestation, contamination, and/or deterioration.
4) Test facilities where studies are conducted using biological organisms should havesupply and other facilities that provide facilities, feed, and supplie, etc. for properly
breeding and managing organisms.
3. Facilities for Handling Test and Reference Items
1) To prevent contamination or mix-ups, there should be separate rooms or areas forreceipt and storage of the test and reference items, and mixing of the test items with avehicle.
2) Storage rooms or areas for the test items should be separate from rooms or areas
containing the test systems. They should be adequate to preserve identity, concentration,
purity, and stability, and ensure safe storage for hazardous substances.
4. Study operating areas. Test facilities should have isolated operating areas necessary for
conducting each phase of studies such as hemanalysis, pathology examination, operation,
and autopsy.
5. Archive Facilities. Archive facilities should be provided for the secure storage and retrievalof study plans, raw data, final reports, samples of test items and specimens. Archive
design and archive conditions should protect contents from untimely deterioration.
6. Waste Disposal. Handling and disposal of wastes should be carried out in such a way as
not to jeopardize the integrity of studies. This includes provision for appropriate collection,
storage and disposal facilities, and decontamination and transportation procedures.
Article 7 (Apparatus, Material, and Reagents)
1. Apparatus, including validated computerized systems, used for the generation, storage andretrieval of data, and for controlling environmental factors relevant to the study should besuitably located and of appropriate design and adequate capacity.
2. Apparatus used in a study should be periodically inspected, cleaned, maintained, andcalibrated according to Standard Operating Procedures. Records of these activities should bemaintained. Calibration should, where appropriate, be traceable to national or international
standards of measurement.

3. Apparatus and materials used in a study should not interfere adversely with the test
systems.
4.

Chemicals,

reagents,

andsolutionsshouldbelabelled

toindicate

identity(withconcentration if appropriate), expiry date and specific storage instructions. Information
concerning source, preparation date and stability should be available. The expiry date may be
extended on the basis of documented evaluation or analysis.
Article 8 (Test Systems)
1. Physical/Chemical test systems
1) Apparatus used for the generation of physical/chemical data should be suitably locatedand of appropriate design and adequate capacity.
2) The integrity of the physical/chemical test systems should be ensured.
2. Biological test systems
1) Proper conditions should be established and maintained for the storage, housing,handling and care of biological test systems, in order to ensure the quality of the data.
2) Newly received animal and plant test systems should be isolated until their healthstatus has been evaluated. If any unusual mortality or morbidity occurs, this lot should not
be used in studies and, when appropriate, should be humanely destroyed. At theexperimental starting date of a study, test systems should be free of any disease orcondition that might interfere with the purpose or conduct of the study. Test systems that
become diseased or injured during the course of a study should be isolated and treated, if
necessary to maintain the integrity of the study. Any diagnosis and treatment of any
disease before or during a study should be recorded.
3) Records of source, date of arrival, and arrival condition of test systems should bemaintained.
4) Biological test systems should be acclimatized to the test environment for an adequate
period before the first administration/application of the test or reference item.
5) All information needed to properly identify the test systems should appear on theirhousing or containers. Individual test systems that are to be removed from their housing
or containers during the conduct of the study should bear appropriate identification,
wherever possible.
6) During use, housing or containers for test systems should be cleaned and sanitized at
appropriate intervals. Any material that comes into contact with the test system should befree of contaminants at levels that would interfere with the study. Bedding for animals
should be changed as required by sound husbandry practice. Use of pest control agentsshould be documented.
7) Test systems used in field studies should be located so as to avoid interference in the
study from spray drift and from past usage of pesticides.
Article 9 (Test and Reference Items)
1. Receipt, Handling, Sampling and Storage
1) Records including test item and reference item characterization, date of receipt, expiry
date, quantities received and used in studies should be maintained.
2) Handling, sampling, and storage procedures should be identified in order that thehomogeneity and stability are assured to the degree possible and contamination or mix up
are precluded.
3) Storage container(s) should carry identification information, expiry date, and specificstorage instructions.
2. Characterization
1) Each test and reference item should be appropriately identified (e.g., code, Chemical
Abstracts Service Registry Number [CAS number], name, biological parameters).
2)

For

each

study,

theidentity,

includingbatch

number,purity,composition,

concentrations, or other characteristics to appropriately define each batch of the test or
reference items should be known.
3) In cases where the test item is supplied by the sponsor, there should be a mechanism,
developed in co-operation between the sponsor and the test facility, to verify the identityof the test item subject to the study.
4) The stability of test and reference items under storage and test conditions should beknown for all studies.
5) If the test item is administered or applied in a vehicle, the homogeneity, concentrationand stability of the test item in that vehicle should be determined. For test items used infield studies (e.g., tank mixes), these may be determined through separate laboratory
experiments.
6) A sample for analytical purposes from each batch of test item should be retained forall studies except short-term studies.

Article 10 (Standard Operating Procedures)
1. A test facility should have written Standard Operating Procedures approved by test facility
management that are intended to ensure the quality and integrity of the data generated bythat test facility. Revisions to Standard Operating Procedures should be approved by test
facility management.
2. Each separate test facility unit or area should have immediately available current Standard
Operating Procedures relevant to the activities being performed therein. Published text books,
analytical methods, articles and manuals may be used as supplements to these Standard
Operating Procedures.
3. Deviations from Standard Operating Procedures related to the study should be documented
and should be acknowledged by the Study Director and the Principal investigator(s), as
applicable.
4. If the Standard Operating Procedure is revised, the revision contents and date should berecorded and maintained.
5. Standard Operating Procedures should be available for, but not be limited to, thefollowing categories of test facility activities. The details given under each heading are to beconsidered as illustrative examples.
1) Test and Reference Items - Receipt, identification, labelling, handling, sampling and storage
2) Apparatus, Materials and Reagentsa. Apparatus
Use, maintenance, cleaning and calibrationb. Computerised Systems
Validation, operation, maintenance, security, change control and back-up.
c. Materials, Reagents and Solutions
Preparation and labelling.
3) Record Keeping, Reporting, Storage, and Retrieval - Coding of studies, data collection,
preparation of reports, indexing systems, handling of data, including the use ofcomputerized systems.
4) Test System (where appropriate)a. Room preparation and environmental room conditions for the test system.
b. Procedures for receipt, transfer, proper placement, characterization, identification andcare of the test system.

c. Test system preparation, observations and examinations, before, during and at theconclusion of the study.
d. Handling of test system individuals found moribund or dead during the study.
e. Collection,

identification andhandling of specimens including necropsy andhistopathology.
f. Siting and placement of test systems in test plots.
5) Quality Assurance Procedures - Operation of Quality Assurance personnel in planning,scheduling, performing, documenting and reporting inspections.
Article 11 (Conduct of the Study)
1. Study Plan - For each study, a written plan should exist prior to the initiation of thestudy. The study plan should be approved by dated signature of the Study Director andverified for GLP compliance by Quality Assurance personnel as specified in Section 2.2.1.b.,above. The study plan should also be approved by the test facility management and thesponsor, if required by national regulation or legislation in the country where the study is
being performed.
1) Amendments to the study plan should be justified and approved by dated signature of
the Study Director and maintained with the study plan2) Deviations from the study plan should be described, explained, acknowledged anddated in a timely fashion by the Study Director and/or Principal investigator(s) andmaintained with the study raw data.
2. Content of the Study Plan - The study plan should contain, but not be limited to thefollowing information:
1) Identification of the Study, the Test Item and Reference Item
a. A descriptive title;
b. A statement which reveals the nature and purpose of the study;c. Identification of the test item by code or name (IUPAC; CAS number, biologicalparameters, etc.);
d. The reference item to be used.
2) Information Concerning the Sponsor and the Test Facility
a. Name and address of the sponsor;
b. Name and address of any test facilities and test sites involved;c. Name and address of the Study Director;

d. Name and address of the Principal Investigator(s), and the phase(s) of the study
delegated by the Study Director and under the responsibility of the Principal
Investigator(s).
3) Datesa. The date of approval of the study plan by signature of the Study Director. The dateof approval of the study plan by signature of the test facility management and sponsor
if required by national regulation or legislation in the country where the study is being
performed.
b. The proposed experimental starting and completion dates.
4) Test Methods - Reference to the OECD Test Guideline or other test guideline or
method to be used.
5) Issues (where applicable)
a. The justification for selection of the test system;b. Characterization of the test system, such as the species, strain, sub-strain, source of
supply, number, body weight range, sex, age and other pertinent information;c. The method of administration and the reason for its choice;d. The dose levels and/or concentration(s), frequency, and duration of administration/
application;e. Detailed information on the experimental design, including a description of thechronological procedure of the study, all methods, materials and conditions, type andfrequency of analysis, measurements, observations and examinations to be performed,
and statistical methods to be used (if any).
6) Records - A list of records to be retained.
3. Conduct of the Study
1) A unique identification should be given to each study. All items concerning this study
should carry this identification. Specimens from the study should be identified to confirm
their origin. Such identification should enable traceability, as appropriate for the specimen
and study.
2) The study should be conducted in accordance with the study plan.
3) All data generated during the conduct of the study should be recorded directly,
promptly, accurately, and legibly by the individual entering the data. These entries should
be signed or initialed and dated.

4) Any change in the raw data should be made so as not to obscure the previous entry,
should indicate the reason for change and should be dated and signed or initialed by theindividual making the change.
5) Data generated as a direct computer input should be identified at the time of data
input by the individual(s) responsible for direct data entries. Computerized system design
should always provide for the retention of full audit trails to show all changes to the data
without obscuring the original data. It should be possible to associate all changes to datawith the persons having made those changes, for example, by use of timed and dated(electronic) signatures. Reason for changes should be given.

Article 12 (Reporting of Study Results)
1. General Matters
1) A final report should be prepared for each study. In the case of short term studies, astandardized final report accompanied by a study specific extension may be prepared.
2) Reports of Principal investigators or scientists involved in the study should be signed
and dated by them.
3) The final report should be signed and dated by the Study Director to indicate
acceptance of responsibility for the validity of the data. The extent of compliance withthese Principles of Good Laboratory Practice should be indicated.
4) Corrections and additions to a final report should be in the form of amendments.
Amendments should clearly specify the reason for the corrections or additions and should
be signed and dated by the Study Director.
5) Reformatting of the final report to comply with the submission requirements of anational registration or regulatory authority does not constitute a correction, addition oramendment to the final report.
2. Content of the Final Report - The final report should include, but not be limited to, thefollowing information:
1) Identification of the Study, the Test Item and Reference Item
a. A descriptive title;b. Identification of the test item by code or name (IUPAC, CAS number, biologicalparameters, etc.);c. Identification of the reference item by name;d. Characterization of the test item including purity, stability and homogeneity.
2) Information Concerning the Sponsor and the Test Facility
a. Name and address of the sponsor;
b. Name and address of any test facilities and test sites involved;c. Name and address of the Study Director;
d. Name and address of the Principal investigator(s) and the phase(s) of the study
delegated, if applicable;e. Name and address of scientists having contributed reports to the final report.
3) Dates - Experimental starting and completion dates.
4) Statement - A Quality Assurance Program statement listing the types of inspections
made and their dates, including the phase(s) inspected, and the dates any inspection results
were reported to management and to the Study Director and Principal Investigator(s), if
applicable. This statement would also serve to confirm that the final report reflects theraw data.
5) Description of Materials and Test Methods
a. Description of methods and materials used;b. Reference to OECD Test Guideline or other test guideline or method.
6) Resultsa. A summary of results;b. All information and data required by the study plan;c. A presentation of the results, including calculations and determinations of statisticalsignificance;d. An evaluation and discussion of the results and, where appropriate, conclusions.
7) Storage - The location(s) where the study plan, samples of test and reference items,
specimens, raw data and the final report are to be stored.

Article 13 (Storage and Retention of Records and Materials)
1. The following should be retained in the archives for the period specified by theappropriate authorities:
1) The study plan, raw data, samples of test and reference items, specimens, and the final
report of each study;2) Records of all inspections performed by the Quality Assurance Program, as well asmaster schedules;
3) Records of qualifications, training, experience and job descriptions of personnel;
4) Records and reports of the maintenance and calibration of apparatus;
5) Validation documentation for computerized systems;
6) The historical file of all Standard Operating Procedures;
7) Environmental monitoring records.
2. When the storage period is set and the test material is discarded, a waste record should
be kept.
3. If samples and samples of test and control materials are discarded before the expiration of
the storage period for unavoidable reasons, they should be documented in due course.
4. Material retained in the archives should be indexed so as to facilitate orderly storage andretrieval.
5. Only personnel authorized by management should have access to the archives.
6. Movement of material in and out of the archives should be properly recorded.
7. If a test facility or an archive contracting facility goes out of business and has no legal
successor, the archive should be transferred to the archives of the sponsor(s) of thestudy(s).

Annex 2. Procedure for Designation and/or Changes to Designation of GLP facility(related to Article 4 of the Regulation)

Article 1 (Purpose)
The purpose of this regulation is to prescribe matters on how to designate or change thedesignation of chemical test facilities (hereinafter referred to as "test facility") under Article 4.

Article 2 (Application for designation)
A person who intends to receive a designation of the facility under Article 4 shall submit itto the Minister of Environment, attaching the following attached documents to the application
for designation of the facility specified in Annex 21 of the Rules. The Minister ofEnvironment shall notify the President of the National Institute of Environmental Research
immediately upon receipt of the application for designation.
1. Facility status statement
2. Management status statement
3. Proof of test ability (test field or test types)
Article 3 (How to prepare attached documents)
1. Facility status statement should include the followings:
1) Facility's layout, structure and size2) Housing and container of test systems
3) Supply facilities for test systems
4) Facilities for handling test and reference items
5) Test conducting areas
6) Archive facilities
7) Animal care facilities
8) Equipment and layout9) Waste handling and disposal facilities
2. Management status statement should include
1) Personnel and organization
2) Compliance matters of test facility management and study director

3) Organization, management and activities of Quality Assurance Personnel
4) Housing and Care of test systems5) Storage and retention of data such as records6) Other facilities and management-related plans
3. Data for proving test capacity regarding designation are as follows:
1) More than 3 study plans and final reports for short-term acute toxicity test types
2) More than 1 study plan and final report for repeated chronic toxicity test types
3) Results of positive and negative reference items (in case that positive and negativereference item test is required)
4. Facility status statement, operational status statement and data proving test capability (testfields or test types) should be recorded in detail as it is used as evaluation data.

Article 4 (Review of application for designation)
The inspection team under Article 7 shall review the submitted application for designation,
taking into account the adequacy of the application for designation, the omission andspecificity of the attached documents.

Article 5 (Supplementation of Data)
1. The Minister of Environment may request the test facility applying for designation to
supplement the necessary data based on the results of the inspection by the Inspection
Team.
2. When the Minister of Environment asks for the supplementation of necessary data, theMinister shall specifically provide details of the contents of supplementation, the reasonsfor the supplementation, and the period for supplementation.
3. The Minister of Environment may reject the application for designation if test facility
applying for designation has not submitted within the period of time presented or theapplication for designation is found to be inadequate supplemented the supplementary data

Article 6 (On-site inspection of test facility)
If the adequacy of the application for designation is determined, the on-site inspection dateshould be determined in consideration of the schedule of the test facility and inspectors, andthen the on-site inspection shall be carried out for the application for designation.

Article 7 (Responsibility of test facility)
Test facility management shall submit supplementary documents within a grace period at therequest of inspection team based on on-site inspection results

Article 8 (Decision of designation of facility)
The criteria for designation is, in principle, based on the findings of the inspection results
and supplementary data
1. Compliance: When there are no findings or in case where reasonable supplementary data
are submitted for minor deviations from the Principles of GLP;
2. Not-in compliance: When significant deviations from good laboratory practices are foundthat impair the reliability of the study, or when appropriate supplementary data are notsubmitted for minor deviations from good laboratory practices.

Article 9 (Report of Inspection)
The inspection team shall prepare and submit a final inspection report to the Minister ofEnvironment after determining the status of designation of a test facility in accordance with theprinciple of writing a report in Annex 3 of Article 4 (“Test facility inspection and study audit”).

Article 10 (Designation of facility)
The Minister of Environment shall issue a GLP compliance certificate to the test facility
subject to in-compliance in accordance with Appendix form 22 of the Rules .

Article 11 (Changes of Designation)
1. When the facility designated as a laboratory wants to make the following changes, it shallapply for changes to the original designation and other attached documents deemed necessary,
fill out an application for changes to designation of test facility as specified in Annex No. 23of the Rules:a) Change of name, location, representative or management of the facility designated as thetest laboratory;b) Designated scope of test (test field or test types)
2. When the Minister of Environment receives an application for designation of change,
Minister of environment shall designate the change if it is judged to be valid.
a) In case of subparagraph a)1) of Article 11, the Minister of Environment shall confirm
the facts, and approve the changed designation if it is deemed appropriate.
b) In case of subparagraph a)2) of Article 11 and if it is deemed appropriate, the Ministerof Environment shall approve the changed designation of a test facility corresponding to
Article 4 on designation and its evaluation.
3. In case where the Minister of Environment deems it appropriate to apply for designation
for change, he/she shall issue the designation for change to a test facility by indicatingchanges in the background of the certificate previously issued.

Article 12 (Extra)
Matters not provided for in this Regulation, such as supplementation or rejection shall begoverned by ⌜Civil Petitions Treatment Act⌟

Annex 3. Test Facility Inspection and Study Audit (Related to Article 4 of the Regulation)- Overly adopted “Documents No. 3 and 9 of the OECD Series on the Principles of GLP
Compliance Monitoring” with some modifications

Article 1 (Purpose)
The purpose of this regulation is to prescribe matters concerning inspection and follow-up
management for the designation of facility capable of performing nonclinical testing ofchemicals, pharmaceuticals, pesticide products, cosmetic products.

Article 2 (Definitions of Terms)
1. “Initial inspection” refers to the inspection of the actual status by inspection team inconnection with the designation of the test facility, and refers to the inspection of theoperation of the test facility and whether the performance of the test complies with theoperating regulations of the good laboratory practice. This inspection includes a preliminary
inspection to review the application for designation, on-site inspection, an examination of theorganization, operation, and equipment of the test facility, and interviews with key personnel.
A study audit is also conducted.
2. “Follow-up management” refers to period evaluation and study audits to confirm thecompliance of the good laboratory practice with the designated facility
3. “Periodic inspection” means the regular evaluation of the compliance status of the goodlaboratory practice every two years after the designation of the facility designated as the test
laboratory
4. “Study audit” refers to evaluation of the accuracy of the study data, the compliance of thestudy plan and the standard operating procedure for the study conducted by the test facility,
the comparison of the study data with the records related to the final or interim report, andadditions not included in the final report.
5. “Inspector” is a public official or experts in the relevant field who performs inspections
and follow-up management of a test facility belonging to the Ministry of Environment, theNational Institute of Environmental Research, Ministry of Food and Drug Safety, and the
Rural Development Administration.
6. “Inspection team” refers to a group of inspectors who participate in inspections andfollow-up work. The inspection team of good laboratory practice may be operated as a joint
gathering of inspectors from different ministries with regard to mutual recognition oflaboratories.
7. “External specialist” refers to an expert other than inspectors appointed for technical advice
in carrying out inspections and follow-up management

Article 3 (Initial and Periodic Inspections)
1. General Matters
1) Initial inspection is carried out for all laboratories applying for test facility designation
for the purpose of producing study data submitted to the relevant ministries for theregistration of chemicals.
2) Periodic inspection is carried out for all laboratories designated as test facility.
3) Initial and periodic inspections include pre-inspection and on-site inspections, and study
audits may also be conducted.
4) Inspectors may request relevant data to assess the reliability of study data related tophysicalandchemicalproperties,

toxicologicalproperties,

pharmacologicalproperties,

eco-toxicological properties, degradability and bioaccumulation properties, etc and receive
technical advice from external specialists.
5) Inspectors should devise a plan for conducting initial and periodic inspections with theutmost respect for the request of the responsible management of the facility in order tominimize inconvenience to the normal performance of the facility.
6) Inspectors and external specialists, who conduct initial and periodic inspections, shall notdisclose

confidential

business

information,

study

results,orcommerciallyvaluable

information from facilities. Inspectors should prepare a memorandum of security relating to
the protection of information when requested by a laboratory that has undergone designatedand periodic inspection.
2. Inspection procedure
1) Pre-inspection
a. Prior to conducting a Test Facility Inspection or Study Audit, inspectors shouldfamiliarise themselves with the facility which is to be visited. Any existing informationon the facility should be reviewed. This may include previous inspection reports, thelayout of the facility, organisation charts, study reports, protocols and curricula vitae(CVs) of personnel. Where no previous test facility inspections have been conducted, apre-inspection visit can be made to obtain relevant information.
b. In the case of initial inspection, the pre-inspection may be replaced by a review of
the application for designation according to Procedure for Designation and/or Changes to
Designation of GLP facility in Annex 2.
c. Test facilities may be informed of the date and time of inspector’s arrival, theobjective of their visit and the length of time they expect to be on the premises. This
could allow the test facility to ensure that the appropriate personnel and documentation
are available.
2) Starting conferencea. The inspector may hold a starting conference to inform the management and staff ofthe facility of the reason for the test facility inspection or study audit that is about totake place, and to identify the facility areas, study(ies) selected for audit, documents andpersonnel likely to be involved.
b. The administrative and practical details of a test facility inspection should be discussedwith the management of the facility at the start of the visit. At the starting conference,
inspectors should:a) Outline the purpose, scope, and schedule of the inspection;b) Describe the documentation which will be required for the test facility inspection,such as lists of on-going and completed studies, study plans, standard operatingprocedures, study reports, etc. Access to and, if necessary, arrangements for the copyingof relevant documents should be agreed upon at this time;c) Clarify or request information as to the management structure(organisation) andpersonnel of the facility;d) Request information as to the conduct of studies not subject to GLP Principles in
the areas of the test facility where GLP studies are being conducted;e) Make an initial determination as to the parts of the facility to be covered during thetest facility inspection;f) Describe the documents and specimens that will be needed for on-going or completed
study(ies) selected for study audit;g) Indicate that a closing conference will be held at the completion of the inspection.

c. Before proceeding further with a test facility inspection, it is advisable for theinspector(s) to establish conatct with the facility’s Quality Assurance (QA) unit. Wheninspecting a facility, inspectors will find it helpful to be accompanied by a member ofthe QA unit. Inspectors may wish to request that a room be set aside for examination of
documents and other activities.
3) Inspection points
a. Organization and personnela) The inspector should determine whether the test facility has sufficient qualified
personnel, staff resources and support services for the variety and number of studies
undertaken, the organisational structure is appropriate, and management has established apolicy regarding training and staff health surveillance appropriate to the studies
undertaken in the facility.
b) The inspector should ask the management to to produce certain documents to
identify key information about the organization and personnel of the test facility.
- Floor plans;- Documents relating to the overall operating plan of the facility;- Facility management and scientific organisation charts;- CVs of personnel involved in the studies selected for the study audit;- List(s) of on-going and completed studies with information on the type of study,
initiation/completion dates, test system, method of application of test substance, nameof Study Director, etc.);- Staff health surveillance policies;- Staff job descriptions and staff training programme and records;- An index to the test facility’s SOPs;- Specific SOPs as related to the studies or procedures being inspected or audited;- List of Study Directors and sponsors associated with the study(ies) being auditedc) The inspector must check that:- Lists of on-going and completed studies to ascertain the level of work being
undertaken by the test facility;- The identity and qualifications of the Study Director(s), the head of the Quality
Assurance unit and other personnel;— Existence of SOPs for all relevant areas of testing.

b. Quality assurance programmea) Inspectors should determine whether the mechanisms used to assure management thatstudies are conducted in accordance with GLP Principles are adequate.
b) The head of the Quality Assurance (QA) Unit should be asked to demonstrate thesystems and methods for QA inspection and monitoring of studies, and the system forrecording observations made during QA monitoring as specified in (a).
c) The inspector shall check the following to evaluate the facility's quality assurance unit:- Qualifications of the head of QA, and of all QA staff;- QA unit functions independently from the staff involved in the studies;- How the QA unit schedules and conducts inspections, how it monitors identified
critical phases in a study, and what resources are available for QA inspections andmonitoring activities;- Extent and depth of QA monitoring during the practical phases of the study;- Extent and depth of QA monitoring of routine test facility operation;- QA procedures for checking the final report to ensure its agreement with the raw data;- Whether management receives reports from QA concerning problems likely to affect
the quality or integrity of a study;- Role of quality assurance unit if the study is conducted with insufficient test facilities;- Types of checks that can be taken when the test period is too short to check each study;- Quality Assurance Unit's actions when deviations are found;- QA role, if any, if studies or parts of studies are done in contract laboratories;- The part played, if any, by QA in the review, revision and updating of SOPs
c. Facilitya) The inspector will determine if the test facility, whether indoor or outdoor, is ofsuitable size, design and location to meet the demands of the studies being undertaken.
b) The inspector shall check the following to determine the suitability of the facility;- Whether the design enables an adequate degree of separation so that, e.g., test items,
animals, diets, pathological specimens, etc. of one study cannot be confused with thoseof another;- Environmental control and monitoring procedures exist and function adequately in
critical areas, e.g., animal and other biological test systems rooms, test item storage
areas, laboratory areas;- The general housekeeping is adequate for the various facilities and that there are, if
necessary, pest control procedures.
d. Care, housing and containment of biological test systemsa)Inspectors should determine whether the test facility, if engaged in studies using

animals or other biological test systems, has support facilities and conditions for theircare, housing and containment, adequate to prevent stress and other problems which
could affect the test system and hence the quality of data. A test facility may be
carrying out studies which require a diversity of animal or plant species as well as
microbial or other cellular or sub-cellular systems. The type of test systems being usedwill determine the aspects relating to care, housing or containment that the Inspector
will monitor.
b) The inspector should ensure that:- there are facilities adequate for the test systems used and for testing needs;- there are arrangements to quarantine animals and plants being introduced into thefacility and that these arrangements are working satisfactorily;- there are arrangements to isolate animals (or other elements of a test system, if
necessary) known to be, or suspected of being, diseased or carriers of disease;- there is adequate monitoring and record-keeping of health, behaviour or otheraspects, as appropriate to the test system;- the equipment for maintaining the environmental conditions required for each test
system is adequate, well maintained, and effective;- animal cages, racks, tanks and other containers, as well as accessory equipment, arekept sufficiently clean;- analyses to check environmental conditions and support systems are carried out as required;- facilities exist for removal and disposal of animal waste and refuse from the test
systems and that these are operated so as to minimise vermin infestation, odours,
disease hazards and environmental contamination;- storage areas are provided for animal feed or equivalent materials for all test
systems; that these areas are not used for the storage of other materials such as test
items, pest control chemicals or disinfectants, and that they are separate from areas inwhich animals are housed or other biological test systems are kept
- stored feed and bedding are protected from deterioration by adverse environmental

conditions, infestation or contaminatione. Apparatus, Material, Reagent, Specimena) Inspectors should determine whether the test facility has suitably located, operational
apparatus in sufficient quantity and of adequate capacity to meet the requirements ofthe tests being conducted in the facility and that the materials, reagents and specimens
are properly labeled, used and stored.
b) The inspector should check that:- apparatus is clean and in good working order;- records have been kept of operation, maintenance, verification, calibration andvalidation of measuring equipment and apparatus (including computerised systems);- materials and chemical reagents are properly labelled and stored at appropriate
temperatures and that expiry dates are not being ignored. Labels for reagents should
indicate their source, identity and concentration and/or other pertinent information;- specimens are well identified by test system, study, nature and date of collection;- apparatus and materials used do not alter to any appreciable extent the test systems
f. Test systemsa) Inspector should determine whether adequate procedures exist for the handling andcontrol of the variety of test systems required by the studies undertaken in the facility,e.g., chemical and physical systems, cellular and microbic systems, plants or animalsb) The inspector should confirm that:o Physical and chemical system- where required by study plans, the stability of test and reference items wasdetermined and that the reference items specified in study plans were used;- in automated systems, data generated as graphs, recorder traces or computer
print-outs are documented as raw data and archived.
o Biological test systems : Taking into account the relevant aspects referred to inparagraph 3) d), the inspector shall confirm that:- whether the test system is specified in the study plan;- test systems are adequately and, if necessary and appropriate, uniquely identified
throughout the study; and that records exist regarding receipt of the test systems anddocument fully the number of test systems received, used, replaced or discarded;- housing or containers of test systems are properly identified with all the necessaryinformation;- there is an adequate separation of studies being conducted on the same animal
species (or the same biological test systems) but with different substances;- there is an adequate separation of animal species (and other biological test systems)
either in space or in time;- the biological test system environment is as specified in the study plan or in SOPs
for aspects such as temperature, or light/dark cycles;- the recording of the receipt, handling, housing or containment, care and healthevaluation is appropriate to the test systems;- written records are kept of examination, quarantine, morbidity, mortality, behaviour,
diagnosis and treatment of animal and plant test systems or other similar aspects asappropriate to each biological test system;- there are provisions for the appropriate disposal of test systems at the end of tests.
g. Test and reference itemsa) The inspector shall determine whether the test facility has procedures designed (i) toensure that the identify, potency, quantity and composition of test and reference items
are in accordance with their specifications, and (ii) to properly receive and store test
and reference items.
b) The inspector should check that:- there are written records on the receipt (including identification of the person
responsible), and for the handling, sampling, usage and storage of tests and reference
items;- test and reference items containers are properly labelled;- records relating to the determination of identity, purity, composition, stability, etc.
- storage conditions are appropriate to preserve the concentration, purity and stabilityof the test and reference items;- there are written records on the determination of identity, purity, composition,
stability, and for the prevention of contamination of test and reference items, whereapplicable;- there are procedures for the determination of the homogeneity and stability of
mixtures containing test and reference items, where applicable;- when the test is of longer than four weeks’ duration, samples from each batch oftest and reference items have been taken for analytical purposes and that they havebeen retained for an appropriate time;- procedures for mixing substances are designed to prevent errors in identification or
cross-contamination.
h. Standard operating procedurea) determine whether the test facility has written SOPs relating to all the important
aspects of the its operations, considering that one of the most important management
techniques for controlling facility operations is the use of written SOPs. These relate
directly to the routine elements of tests conducted by the test facility.
b) The inspector should ensure that:i) each test facility area has immediately available relevant, authorised copies of SOPs;ii) procedures exist for revision and updating of SOPs;
iii) any amendments or changes to SOPs have been authorised and dated;iv) historical files of SOPs are maintained;v) SOPs are available for, but not necessarily limited to, the following activities:- receipt; determination of identity, purity, composition and stability; labelling;
handling; sampling; usage; and storage of test and reference items;- use, maintenance, cleaning, calibration and validation of measuring apparatus,
computerised systems and environmental control equipment;- preparation of reagents and dosing formulations;- record-keeping, reporting, storage and retrieval of records and reports;- preparation and environmental control of areas containing the test systems;- receipt, transfer, location, characterisation, identification and care of test systems;- handling of the test systems before, during and at the termination of the study;- disposition of test systems;- use of pest control and cleaning agents;- operation of quality assurance programme.

I. Performance of the studya) The inspector should verify that written study plans exist and that the plans and the
conduct of the study are in accordance with GLP Principles.
b) The inspector should basically check:- the study plan and any amendments to the study plan were signed and dated by

the Study Director;- Whether the results described in the test report accurately and completely reflect the
study raw data and are consistent;- Whether the date confirmed by the sponsor is recorded in the study plan;- measurements, observations and examinations were in accordance with the study
plan and relevant SOPs;- the results of these measurements, observations and examinations were recorded
directly, promptly, accurately and legibly and were signed (or initialled) and dated;- any changes in the raw data, including data stored in computers, did not obscureprevious entries, included the reason for the change and identified the person
responsible for the change and the date it was made;- computer-generated or stored data have been identified and that the procedures toprotect them against unauthorised amendments or loss are adequate;- the computerised systems used within the study are reliable, accurate and have beenvalidated;- any unforeseen events recorded in the raw data have been investigated andevaluated;- the results presented in the reports of the study (interim or final) are consistent andcomplete and that they correctly reflect the raw data.
j. Reporting of study resultsa) The determine whether final reports are prepared in accordance with GLP Principles.
b) When examining a final report, the inspector should check that:- it is signed and dated by the Study Director to indicate acceptance of responsibility
for the validity of the study and confirming that the study was conducted inaccordance with GLP Principles;- it is signed and dated by other principal scientists, if reports from co-operating
disciplines are included;- Quality Assurance statement is included in the report and that it is signed and dated;- any amendments were made by the responsible personnel;- it lists the archive location of all samples, specimens and raw data.
k. Storage and retention of recordsa) The inspector should determine whether the facility has generated adequate records

and reports and whether adequate provision has been made for the safe storage andretention of records and materials.
b) The inspector should check:- that a person has been identified as responsible for the archive;- the archive facilities for the storage of study plans, raw data (including that fromdiscontinued GLP Studies), final reports, samples and specimens and records ofeducation and training of personnel;- the procedures for retrieval of archived materials;- the procedures whereby access to the archives is limited to authorised personnel andrecords are kept of personnel given access to raw data, slides, etc.;- that an inventory is maintained of materials removed from, and returned to, thearchives;- that records and materials are retained for the required or appropriate period of timeand are protected from loss or damage by fire, adverse environmental conditions, etc.
Article 4 (Study Audit)
1. General Matters
1) Initial and periodic inspection of a test facility usually involves a study audit, which
examines the quality of ongoing or completed studies. The audit may be carried out at therequest of the relevant ministries carrying out tasks such as chemical registration, or may
be carried out separately from the initial inspection or period inspection.
2) The audit can be carried out by preparing general audit guidelines and should be carriedout to accurately determine the quality of the study according to the scope and nature of
the audit.
3) Inspectors and external specialists shall not disclose to outsiders confidential information,commercially valuable information or study results obtained during the audit. Inspectors
should prepare a memorandum of security regarding information protection at the request of
the test facility
2. The purpose of the audit is to reconstitute the study by comparing the final report withthe study plan, standard operating procedures, study raw data and other stored materials, andto determine the quality of the study results. Inspectors may be assisted by external
specialists to effectively conduct examinations.

3. Study audit checklist : when conducting a study audit, the inspector should:
1) obtain names, job descriptions and summaries of training and experience for selected
personnel engaged in the study(ies) such as the Study Director and principal scientists;
2) check that there is sufficient staff trained in relevant areas for the study(ies) undertaken;
3) identify individual items of apparatus or special equipment used in the study andexamine the calibration, maintenance and service records for the equipment;4) review the records relating to the stability of the test items, analyses of test items andformulations, analyses of feed, etc.;
5) attempt to determine, through the interview process if possible, the work assignments of
selected individuals participating in the study to ascertain if these individuals had the timeto accomplish the tasks specified in the study plan or report;
6) obtain copies of all documentation concerning control procedures or forming integral
parts of the study, including:- Study plan;- SOPs in use at the time the study was done;- log books, laboratory notebooks, files, worksheets, print-outs of computer-stored data,etc.; check calculations, where appropriate;- Final report7) In studies in which animals (i.e., rodents and other mammals) are used, the Inspectors
should follow a certain percentage of individual animals from their arrival at the test
facility to autopsy. They should pay particular attention to the records relating to:- animal body weight, food/water intake, dose formulation and administration, etc.;- clinical observations and autopsy findings;- clinical chemistry;- Anatomical findings and pathology

Article 5 (Completion of Inspection or Study Audit)
1. When a test facility inspection or study audit has been completed, the inspector should
hold a closing conference according to his/her inspection findings.
1) Inspectors should hold their internal meeting to discuss the findings of on-site
inspections or study audit, and prepare a draft inspection report;
2) Inspector will hold a closing meeting attended by representatives of the test facility,such as test facility management, following the internal meeting, explaining the mattersfound during the on-site inspection or study audit. In addition, the inspector shall give theopportunity for a test facility’s objection and clarification of the opinion of the excellent
inspection team, and after the discussion process, prepare a GLP inspection report.
2. In cases where there is a significant impact on the quality of the study results, it may be
finally determined that they are not operating in accordance with the Principles of GLP
3. Inspection team shall take the following measures after on-site inspection or study audit;
1) When the results of on-site inspection or study audit determines that it does not comply
with the Principles of GLP or that needs improvement, the inspector requests the facility tosubmit corrective actions and the results of the action, and after taking corrective actions,the inspector may visit the facility again to confirm the corrections, where necessary.
2) Inspection team will review the results of on-site inspection or study audits, including
the supplementary data submitted, and prepare a final inspection report and submit it to the
Minister of Environment and the President of National Institute of Environmental Research.
3) The Minister and the President should inform the test facility of the final inspection results.
4) When on-site inspection or study audit reveals significant deviations or false datasubmissions from the good laboratory practice regulations, appropriate measures may betaken against the facility in accordance with the relevant laws.
5) Determination of periodic inspection resultsa. Compliance: When there are no findings or in case where reasonable supplementary
data are submitted for minor deviations from the Principles of GLP;
b. Pending: When deviations corresponding to suspension of business are found inaccordance with Article 23, Paragraph 2 of the Act
c. Not-in compliance: In the event of deviations corresponding to revocation ofdesignation of test types or a test facility in accordance with the provisions of Article 23(1) of the Act, such as significant deviations from the GLP Principles that impair thequality of the study.
4. If the study audit is conducted at the request of Receiving Authority or otherregistration-related department, the inspection report should be sent to the relevant ministries
for appropriate review.
Article 6 (Preparation of GLP Inspection Report)

1. General Matters
In order to share the results of initial and periodic inspections or study audits, and related
information, GLP inspection report may be prepared in a certain form and may be used as abasis for mutual recognition of the facility.
2. Report headings
The title of the inspection report should meet the level of information required by therelevant ministries carrying out activities of chemical registration. In general, a heading
consists of a summary, an introduction, a narrative, a summary of a closing conference andthe final inspection results and appendix. All of the information presented under theseheadings should portray an accurate picture of the adherence of the testing facility to the
Principles of GLP and the quality of any study report that may have been audited.
1) Summary : The summary section of the report should be presented first and should
provide background information on the test facility, the type of inspection that was
conducted, the deviations from the GLP Principles that were noted, and the responses of
the test facility to the presented deviations. In accord with national practice, the report may
include the compliance designation of the facility that was assigned by the inspectors.
2) Introduction : the followings are included (some may be omitted):a. The purpose and general description of the inspection, including the legal authority of
the inspectors and the quality standards serving as the basis for the inspection.
b. Inspector's identification and date of inspection
c. Description of types of inspections (e.g., facility, study audit, etc.)
d. General information of the test facility including the company name, address andrelevant persons (Including phone and fax number)e. A description of the test facility identifying the categories of test items and testingthat is done and presenting information on the physical layout and the personnel.
f. The date of the previous GLP inspection, resulting GLP compliance status, and any
relevant changes made by the test facility since that inspection.
3. Narrative
The report should be recorded realistically and completely on the activities performed andobservations made during the inspection process. In particular, deviations from good laboratory
practices should be documented (eg, photocopying, photographs, inspection samples, etc.) andall deviations may be appended as an appendix. The audit report should describe the audit

process that includes part of the data or the actual study that was tested. In addition, minor
details found during the audit should be described and may be attached as an appendix. The
report shall be recorded to fully reflect the following:
1) Organization and personnel
2) Quality Assurance Programme3) Facilities
4) Apparatus, materials, reagents and specimens
5) Test system
6) Test and reference items
7) Standard operating procedure8) Performance of the study9) Reporting of study results10) Storage and retention of records
4. Exit Discussion
1) At the end of an inspection/study audit, an Exit Conference should be held between
the inspection team and the responsible management of the test facility, at which GLP
deviations found during the inspection/study audit may be discussed. During this Exit
Conference, if allowed by national policy, a written list of observations should bepresented describing the GLP deviations if any have been observed. The exit discussion
should be summarized in this section.
2) The report should note the date and time of the Exit Conference; the names ofattendees (inspection team, facility and others), with their affiliations. It should also give a
brief summary of GLP deviations noted by the inspection team during the facility
inspection and/or study audits. Responses of facility representatives to the inspection
team’s remarks should also be described.
3) In the case where a written list of observations has been made available, the test
facility should acknowledge the inspectors’ findings and make a commitment to takecorrective action.
4) If a receipt of documents taken by the inspection team was prepared and signed byfacility management, the person to whom the receipt for documents was provided should
be identified. A copy of the receipt should be included in the Annexes.
5. Annexes

The Annexes should contain copies of documents that have been referenced in the report.
Such documents may include:
1) Organizational charts of the test facility;2) the agenda for the inspection / study audit;3) a listing of SOPs that have been demonstrated during the inspection / study audit;4) a listing of deviations that have been observed;5) photocopies that document observed deviations.
If the inspector is provided with documentation from the facility, the certification may besigned by the facility management and delivered to the facility personnel. A copy of thecertificate may be attached to the appendix.
6. Other information
In addition to the information described above, reports may contain other headings andinformation as appropriate or as required by a Member country’s compliance monitoring
programme.
7. Approval
Report should be signed and dated by the lead inspector and by other inspectors inaccordance with their responsibilities.

Annex 4. Composition and Operation of Inspection Team (Related to Article 7 of the Regulation)

Article 1 (Purpose)
The purpose of this regulation is to prescribe the details necessary for the composition andoperation of the inspection team under Article 7 (2).

Article 2 (Duties)
1. The mission shall conduct the following duties:
1) Initial inspection of test facility2) Follow-up management of test facility
3) Other necessary work

Article 3 (Composition)
1. The inspection team shall consist of inspectors in accordance with Article 2 (5) of Annex
3 (“test facility inspection and study audit”);
2. The inspection team may appoint separate external specialists to seek technical advice, etc.
in specific areas in performing the inspection of test facilities

Article 4 (Operation)
1. Initial and periodic inspections of the test facility shall be conducted by three or moreinspectors, including inspectors from the Ministry of Environment, but at least one inspector
from the Ministry of Food and Drug Safety and Rural Development Administration. However,this may not be the case in the case of an inspection and study audit, etc. for thedesignation or change to designation of a facility only to be performed with chemical
substances
2. The lead inspector shall be elected from among the inspectors who participated in theinitial and periodic inspections of the test facility and oversees the work on such matters.
3. Inspectors who do not participate in the inspector may review the contents of theinspection report to confirm the validity of the facility inspection procedures and results.
4. The lead inspector or inspector should prepare an inspection report.
5. Separate guidance on the qualifications and selection of inspectors may be provided.

Article 5 (Conference)
The lead inspector may convene an inspector meeting if deemed necessary for the conduct of
the test facility's inspection.

Article 6 (Training and Education)
Inspectors should gain experience in education and training related to the designation andfollow-up of test facility in order to improve the quality of their inspection. Guidance on thismay be provided separately.
Article 7 (Allowances and expenses)
1. Inspectors or external specialists who are not public officials may be paid for meeting
attendance in accordance with budget execution standards.
2. Inspectors or external specialists who are not public officials may be provided withfinancial support, such as payment of allowances, within the scope of the budget if they
participate in the test facility's inspection or related education and training or perform
related tasks.
3. Inspectors and external specialists may be paid with domestic or foreign expenses inaccordance with the criteria of subparagraph 2 of the Expenditure Classification Table inAppendix 1 of the Domestic Expense Regulations.

Annex 5. Multi-Site Study (Related to Article 3 of the Regulation): Adopted “Documents No. 13 of the OECD Series on the Principles of GLP andCompliance Monitoring”

Article 1 (Purpose)
The purpose of this regulation is to prescribe matters concerning the planning, performance,
monitoring, recording, reporting and archiving of a multi-site study under Article 3.

Article 2 (Terms of Definition)
1. “Multi-site study” means any study that has phases conducted at more than one site.
Multi-site studies become necessary if there is a need to use sites that are geographically
remote, organisationally distinct or otherwise separated. This could include a department of anorganisation acting as a test site when another department of the same organisation acts as
the test facility.
2. “Phase” is a defined activity or set of activities in the conduct of a study.

Article 3 (Communication)
1. For a multi-site study to be conducted successfully it is imperative that all parties involved
are aware of their responsibilities. In order to discharge these responsibilities, and to deal
with any events that may need to be addressed during the conduct of the study, the flow of
information and effective communication among the sponsor, management at sites, the Study
Director, Principal Investigator(s), Quality Assurance and study personnel is of paramountimportance.
2. The mechanism for communication of study-related information among these parties shouldbe agreed in advance and documented.

Article 4 (Study Management)
1. The decision to conduct study activities at other sites will usually be made by test facility
management in consultation with the Study Director and the sponsor, where necessary.
2. When the Study Director is unable to perform his/her duties at a test site because ofgeographical or organizational separation, the need to appoint a Principal Investigator(s) at atest site(s) arises.
3. Test facility management should facilitate good working relationships with test sitemanagement to ensure study integrity.

Article 5 (Roles and Responsibilities)
1. Sponsor
1) The decision to conduct a multi-site study should be carefully considered by thesponsor in consultation with test facility management before study initiation;2) The sponsor should be aware that, if its site acts as a test site undertaking a phase(s)of a multi-site study, its operations and staff involved in the study are subject to controlof the Study Director. According to the specific situation, this may include visits fromtest facility management, the Study Director and/or inspections by the lead Quality
Assurance. The Study Director has to indicate the extent to which the study complies
with GLP, including any work conducted by the sponsor
2. Test Facility Management
1) Test facility management should approve the selection of test sites. Issues to consider
will include, but are not limited to, practicality of communication, adequacy of Quality
Assurance arrangement, and the availability of appropriate equipment and expertise;2) Test facility management should designate a lead Quality Assurance that has theoverall responsibility for quality assurance of the entire study;3) Test facility management should inform all test site quality assurance units of thelocation of the lead Quality Assurance;
4) If it is necessary to use a test site that is not included in a national GLP compliancemonitoring programme, the rationale for selection of this test site should be documented;
5) Test facility management should make test site management aware that it may besubject to inspection by the national GLP compliance monitoring authority of the country
in which the test site is located. If there is no national GLP compliance monitoring
authority in that country, the test site may be subject to inspection by the GLP
compliance monitoring authority from the country to which the study has been submitted.
3. Test Site Management
1) Test site management is responsible for the provision of adequate site resources andfor selection of appropriately skilled Principal Investigator(s);2) If it becomes necessary to replace a Principal Investigator, test site management will
appoint a replacement Principal Investigator in consultation with the sponsor, the StudyDirector, and test facility management where necessary. Details should be provided to the
Study Director in a timely manner so that a study plan amendment can be issued. The
replacement Principal Investigator should assess the GLP Compliance status of the work
conducted up to the time of replacement
4. Study Director
1) The Study Director should ensure that the test sites selected are acceptable. This may
involve visits to test sites and meetings with test site personnel;
2) If the Study Director considers that the work to be done at one of the test sites canbe adequately controlled directly by him(her)self without the need for a Principle
Investigator to be appointed, he/shre should advise test facility management of thispossibility. Test facility management should ensure that appropriate quality assurance
monitoring of that site is arranged. This could be by the test site’s own Quality
Assurance or by the lead Quality Assurance;3) The Study Director is responsible for the approval of the study plan, including theincorporation of contributions from Principal Investigators. The Study Director will approveand issue amendments to and acknowledge deviations from the study plan, including thoserelating to work undertaken at sites;
4) The Study Director is responsible for ensuring that all staff are clearly aware of therequirements of the study and should ensure that the study plan and amendments areavailable to all relevant personnel;
5) The Study Director should set up specific communication systems (fax, phone, e-mail,mail, etc.) between him(her)self and each Principal Investigator. In addition, the Study
Director should directly liase with each Principal Investigator and not via an intermediary
except where this is unavoidable (e.g. the need for language interpreters);
6) Throughout the conduct of the study, the Study Director should be readily available to
the Principal Investigators. The Study Director should facilitate the co-ordination andtiming of events and movement of samples, specimens or data between sites, and ensurethat Principal Investigators understand chain of custody procedures;
7) The Study Director should liase with Principal Investigators about test site quality
assurance findings as necessary. All communication between the Study Director andPrincipal Investigators or test site quality assurance in relation to these findings should be
documented;

8) The Study Director should ensure that the final report is prepared, incorporating any
contributions from Principal Investigators, and the final report is submitted to the lead
Quality Assurance for inspection;9) The Study Director will sign and date the final report to indicate the acceptance of
responsibility for the validity of the data and to indicate the extent to which the study
complies with OECD GLP Principles. This may be based partly on written assurances
provided by the Principal Investigator(s);10) At test sites where no Principal Investigator has been appointed, the Study Director
should liase with the study personnel conducting the work at those sites directly. These
personnel should be identified in the study plan.
5. Principal Investigator
1) The Principal Investigator acts on behalf of the Study Director for the delegated phaseand its responsible for ensuring compliance with the Principles of GLP for that phase. A
full co-operative, open working relationship between the Principal Investigator and the
Study Director is essential;2) There should be documented agreement that the Principal Investigator will conduct
delegated phase in accordance with the study plan and the principles of GLP. Signature of
the study plan by the Principal Investigator would constitute acceptable documentation;3) Deviations from the study plan of Standard Operating Procedures (SOPs) related to thestudy should be documented at the test site, be acknowledged by the Principal Investigatorand reported to and acknowledged by the Study Director in a timely manner;
4) The Principal Investigator should provide the Study Director with contributions whichenable the preparation of the final report. These contributions should include written
assurance from the Principal Investigator confirming the GLP compliance of the work forwhich he/she is responsible;5) The Principal Investigator should ensure that all data and specimens for which he/she is
responsible are transferred to the Study Director archived as described in the study plan. If
these are not transferred to the Study Director, the Principal Investigator should notify the
Study Director when and where they have been archived;6) During the study, the Principal Investigator should not dispose of any specimens without
the prior written permission of the Study Director.
6. Study Personnel

1) The GLP Principles require that all professional and technical personnel involved in the
conduct of a study have a job description and a record of the training, qualifications andexperience with support their ability to undertake the tasks assigned to them;2) Where study personnel are required to follow approved SOPs from another test site, any
additional training required should be documented;
3) There may be some sites where temporarily employed personnel carry out aspects ofstudy conduct. Where these persons have generated or entered raw data, or have performed
activities relevant to the conduct of the study, records of their qualifications, training andexperience should be maintained. Where these individuals have carried out routine
operations such as livestock handling subject to supervision by more highly qualified staff,
no such personnel records need be maintained.

Article 6 (Quality Assurance)
1. Responsibilities of lead Quality Assurance
1) The lead Quality Assurance should liase with test site quality assurance to ensure
adequate quality assurance inspection coverage throughout the study;2) Particular attention should be paid to documenting the communication between the testsites and the contents of the communication;3) Responsibilities for quality assurance activities at the various sites should be established
before experimental work commences at those sites;
4) The lead Quality Assurance will ensure that the study plan is verified and that the
final report is inspected for compliance with the Principles of GLP;
5) Quality assurance inspections of the final report should include verification that the
Principal Investigator contributions (including evidence of quality assurance at the test site)
have been properly incorporated;
6) The lead Quality Assurance will ensure that a Quality Assurance Statement is prepared
relating to the work undertaken by the test facility including or referencing quality
assurance statements of all test sites;
2. Responsibilities of Test Site Quality Assurance
1) Each test site management is usually responsible for ensuring that there is appropriatequality assurance for the part of the study conducted at their site;2) Quality assurance at each test site should review sections of the study plan relating tooperations to be conducted at their site, and should maintain a copy of the approved

study plan and study plan amendments;3) Quality Assurance at the test site should inspect study-related work at their siteaccording to their own SOPs, unless otherwise required by the lead Quality Assurance,
reporting any inspection results promptly in writing to the Principal Investigator, test sitemanagement, Study Director, test facility management and lead Quality Assurance;4) Quality Assurance at the test site should inspect the Principal Investigator's duties inaccordance with their own test site SOPs and provide a statement relating to the quality
assurance activities to the lead Quality Assurance.

Article 7 (Master Schedules)
1. A multi-site study in which one or more Principal Investigators have been appointed
should feature on the master schedule of all sites concern. It is responsibility of test facility
management and test site management to ensure that this is done.
2. The unique identification of the study must appear on the master schedule in each site,
cross-referenced as necessary to test site identifiers.
3. The Study Director should be identified on the master schedule(s), and the relevant
Principal Investigator shown on each site master schedule.
4. At all site, the start and completion dates of the study phase(s) for which they are
responsible should appear on their master schedule.

Article 8 (Study Plan)
1. For each multi-site study, a single study plan should be issued. The study plan should
clearly identify the names and addresses of all sites involved.
2. The study plan should include the name and address of any Principal Investigator and thephase of the study delegated to them. It is recommended that sufficient information is
included to permit direct contact by the Study Director, e.g. telephone number.
3. The study plan should identify how data generated at sites will be provided to the Study
Director for inclusion in the final report
4. It is useful, if known, to describe in the study plan the location(s) at which the data,
samples of test and reference items and specimens generated at the different sites are to beretained.
5. It is recommended that the draft study plan should be made available to Principal
Investigators for consideration and acknowledgment of their capability to undertake the work

assigned to them, and to enable them to make any specialised technical contribution to thestudy plan if required.
6. The study plan is normally written in a single language, usually that of the Study Director:

1) For multi-national studies, it may be necessary for the study plan to be issued in morethan one language;2) This intention should be indicated in the original study plan;3) All translated study plan shall describe the original version of the plan;4) There will need to be a mechanism to verify the accuracy and completeness of thetranslated study plan;5) The responsibility for the accuracy of the translation is with the study director;
6) The responsibility for the accuracy of the translation can be delegated by the Study
Director to a language expert and should be documented.

Article 9 (Performance of the Study)
1. Facility
1) Sites may not have a full time staff presence during the working data. In this situation
it may be necessary to take additional measures to maintain the physical security of thetest item, specimens and data;
2) When it is necessary to transfer data or any materials among sites, mechanisms tomaintain their integrity need to be established. Special care needs to be taken whentransferring data electronically (e-mail, internet, etc.).
2. Equipment
1) Equipment being used in a study should be fit for its intended purpose. This is also
applicable to large mechanical vehicles or highly specialised equipment that may be usedat some sites;
2) There should be maintenance and calibration records for such equipment that serve toindicate their fitness for indeed purpose at the time of use;
3) Some apparatus (e.g. leased or rented equipment such as large animal scales andanalytical equipment) may not have records of periodic inspection, cleaning, maintenanceand calibration. In such cases, information should be recorded in the study-specific raw
data to demonstrate fitness for intended purpose of the equipment.
3. Control and accountability of study materials

1) Procedures should be in place to ensure that the study materials is provided at theappropriate time at the test site;2) Maintaining integrity/stability during transport is essential, so the use of reliable meansof transportation and chain of custody documentation is critical. Clearly defined proceduresfor transportation, and responsibilities for who does what, are essential;
3) Adequate documentation should accompany each shipment of study material to satisfy
any applicable legal requirements (e.g. customs, health and safety legislation). This
documentation should also provide relevant information sufficient to ensure that it issuitable for its intended purpose on arrival at any site;4) When the test item is transported to each test site at the same time, it should beclearly separated and identified to prevent mixing or cross-contamination.
5) If the test item can be adversely affected by unexpected environmental conditions
during transport, procedures should be in place to maintain the integrity of the test item
being transported. In this regard, it is advisable to have a verification procedure to checkin advance that the environmental conditions necessary to maintain the integrity of the test
items are maintained.
6) The storage, return and disposal of the residual amounts of test and control items usedat the test site should be clearly recorded and controlled.

Article 10 (Reporting of Study Results)
1. The final report of a multi-site study should be prepared in a single final report, including
the raw data from all phases of the study.
2. It may be useful for the Principal Investigators to produce a signed and dated report ofthe phase delegated to them, for incorporation into the final report.
3. The report prepared by the Principal Investigators should include evidence that appropriatequality assurance monitoring was performed at that test site and contain sufficient commentary
to enable the Study Director to write a valid final report covering the whole study.
4. Raw data may be transferred from the Principal Investigator to the Study Director, whoshould ensure that the data are presented in the final report. The final report produced in thisway should identify the Principal Investigator(s) and the phase(s) for which they were
responsible.
5. The Principal Investigators should indicate the extent to which the work for which they
were responsible complies with the GLP Principles, and provide evidence of the qualityassurance inspections performed at that test site.
6. The final report may directly incorporate the contents in item 5 of subparagraph 10, or therequired details may be extracted and included in the Study Director’s compliance claim andQuality Assurance statement in the final report. When the details have been extracted thesource should be referenced and retained.
7. The Study Director must sign and date the final report to indicate acceptance of
responsibility for the validity of all the data.
8. The extent of compliance with the GLP Principles should be indicated with specificreference to the OECD Principles of GLP and Regulations with which compliance is being
claimed.
9. This claim of compliance will cover all phases of the study and should be consistent with
the information represented in the Principal Investigator claims.
10. Test sites that do not comply with the OECD Principles of GLP should be indicated in
the final report
11. The final report should identify the storage location of the study plan, samples of test
and reference items, specimens, raw data and the final report. Reports produced by Principal
Investigators should provide information concerning the retention of materials for which they
were responsible.
12. Amendment to the final report may only be produced by the Study Director. Where thenecessary amendment relates to a phase conducted at any test site the Study Director should
contact the Principal Investigator to agree appropriate corrective actions. These corrective
actions must be fully documented.
13. If a Principal Investigator prepares a report, that report should where appropriate comply
with the same requirements that apply to the final report.

Article 11 (Standard Operating Procedure)
1. The following examples are procedures specific to multi-site studies:
1) Selection and monitoring of test sites;
2) Appointment and replacement of Principal Investigators
3) Transfer of test data, samples and specimens between test sites
4) Verification or approval of foreign language translation of study plans or SOP;
5) Storage, return or disposal of test and reference items being used at remote test sites.
2. SOPs should be immediately available to study personnel when they are conducting

activities, regardless of where they are carrying out the work.
3. Test site personnel should follow test site SOPs.
4. When test site personnel are required to follow other procedures specified by the Study
Director, for example SOPs provided by the test facility management, this requirement should
be identified in the study plan.
5. The Principal Investigator is responsible for ensuring that test site personnel are aware of
the procedures to be followed and have access to the appropriate documentation.
6. If personnel at a test site are required to follow SOPs provided by the test facility
management, it is necessary for test site management to give written acceptance.
7. When SOPs from a test facility have been issued for use at a test site, test facility
management should ensure that any subsequent SOP revisions produced during the course of
the study are also sent to the test site and the superseded versions are removed from use.
The Principal Investigator should ensure that all test site personnel are aware of the revisionand only have access to the current version.
8. When SOPs from a test facility are to be followed at test sites, it may be necessary for
the SOPs to be translated into other languages. In this situation, it is essential that any
translation to be thoroughly checked to ensure that the instructions and meaning of thedifferent language versions remain identical.

Article 12 (Storage and Retention of Records and Materials)
1. During the conduct of multi-site studies, test materials should be stored securely andcompletely.
2. When data are stored away from the test facility, assurance will be needed of the site’sability to readily retrieve data which may be needed for review.
3. When test site storage facilities are not adequate to satisfy GLP requirements, records andmaterials should be transferred to a GLP compliant archive.
4. Test site management should ensure that adequate records are available to demonstrate testsite involvement in the study.