F 42-04

Organisation’s
SANAS No/s.
CHECKLIST for GLP
OECD No.1

Organisation and
Location
Organisation
Representative
Lead Inspector /
Technical Expert
(Key: C = Compliance, NC = Non-complaince, N/A = Not applicable)
Evaluators are encouraged to comment beside each space

C
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1. TEST FACILITY, ORGANISATION AND PERSONNEL

1.1 Test Facility Management’s Responsibilities

1.1.2 Is there a statement which identifies the
a) individual(s) within the test facility who fulfil
the responsibilities of management as
defined by the Principles of Good Laboratory
Practice?

b) Are sufficient qualified personnel,

appropriate facilities equipment and
materials available for the timely and proper
conduct of the study?

c) Are records maintained of the qualifications,

training, experience and job description of
each professional and technical individual?

d) Do personnel clearly understand the

functions they are to perform, and, where
necessary, is training provided for these
functions?

e) Have appropriate and technically valid

Standard Operating Procedures (SOP’s)
been established and being followed, and
are all original and revised SOP’s approved?

f) Is there a Quality Assurance Programme

with designated personnel and is the quality
assurance responsibility being performed in
accordance with the Principles of Good
Laboratory Practice?

g) Is an individual with the appropriate

qualifications, training and experience
appointed as the Study Director prior to the
initiations of the study, is there a procedure
for replacement of the Study Director and is
this documented?

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h) In the event of a multi-site study, is, where

needed, a Principal Investigator appointed,
who is appropriately trained, qualified and
experienced, to supervise the delegated
phase(s) of the study? Is replacement of a
Principal Investigator done according to
established procedures, and documented?

i) Is there documented approval of the study

plan by the Study Director?

j) Has the Study Director made the approved

study plan available to the Quality Assurance
personnel?

k) Is a historical file of all SOP’s maintained?

l) Has an individual been identified as being

responsible for the management of the
archive(s)?

m) Is a master schedule maintained?

n) Do test facility supplies meet requirements

appropriate to their use in a study?

o) For a multi-site study do clear lines of

communication exist between the Study
Director, Principal Investigator(s), the Quality
Assurance Programme(s) and study
personnel?

p) Are test and reference items appropriately

characterised?

q) Have procedures been established to ensure

that computerised systems are suitable for
their intended purpose, and are validated,
operated and maintained in accordance with
the Principles of Good Laboratory Practice?

1.1.3 When a phase(s) of a study is conducted at

a test site, does the test site management
have the responsibilies as defined above,
with the exceptions of 1.1.2(g), (I), (j) and
(o)?

1.2 Study Director’s Responsibilities

1.2.2 Does the Study Director approve the study
(a) plan and any amendments to the plan by
dated signature?

(b) Does the Study Director ensure that the

Quality Assurance personnel have a copy of
the study plan and any amendments in a
timely manner and communicates effectively
with the Quality Assurance personnel as
required during the conduct of the study?

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c) Does the Study Director ensure that study

plans and amendments and SOP’s are
available to study personnel?

d) Does the Study Director ensure that the

study plan and the final report for a multi-
study identify and define the role of any
Principle Investigator(s) and any test
facilities and test sites involved in the
conduct of the study?

e) Does the Study Director ensure that the

procedures specified in the study plan are
followed, assess and document the impact
of any deviations from the study plan on the
quality and integrity of the study, and take
appropriate corrective action if necessary?
Are deviations from the SOP’s during the
conduct of the study acknowledged by the
Study Director?

f) Does the Study Director ensure that all raw

data generated are fully documented and
recorded?

g) Does the Study Director ensure that

computerised systems used in the study
have been validated?

h) Does the Study Director sign and date the

final report to indicate acceptance of
responsibility for the validity of the data and
to indicate the extent to which the study
complies with the Principles of Good
Laboratory Practice?

i) Does the Study Director ensure that after

completion (including termination) of the
study, the study plan, the final report, raw
data and supporting material are archived?

1.3 Principal Investigator’s Responsibilities

1.3.1 Does the Principal Investigator ensure that
the delegated phases of the study are
conducted in accordance with the applicable
Principles of Good Laboratory Practice?

1.4 Study Personnel’s Responsibilities

1.4.1 Are all personnel involved in the conduct of
the study knowledgeable in those parts of
the Principles of Good Laboratory Practice
which are applicable to their involvement in
the study?

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1.4.2 Do the Study Personnel have access to the

study plan and appropriate SOP’s applicable
to their involvement in the study?
Do they comply with the instructions given
on these documents?
Is any deviation from these instructions
documented and communicated directly to
the Study Director, and/or, if appropriate, the
Principal Investigator(s)?

1.4.3 Do the Study Personnel record raw data

promptly and accurately and in compliance
with the Principles of Good Laboratory
Practice?
Are they responsible for the quality of their
data?

1.4.4 Do the Study Personnel exercise health

precautions to minimise risk to themselves
and to ensure the integrity of the study?
Do they communicate to the appropriate
person any relevant known health or medical
condition in order that they can be excluded
from operations that may affect the study?

2. QUALITY ASSURANCE PROGRAMME

2.1 General
2.1.1 Does the test facility have a documented
Quality Assurance Programme to ensure
that studies performed are in compliance
with the Principles of Good Laboratory
Practice?

2.1.2 Is the Quality Assurance Programme carried

out by an individual(s) designated by, and
directly responsible to management and
who is familiar with the test procedures?

2.1.3 Is this individual(s) free of involvement in the

conduct of the study being assured?

2.2 Responsibilities of the Quality Assurance

Personnel
2.2.1 Do the QA personnel maintain copies of all
a) approved study plans and SOP’s in use in
the test facility and have access to an up-to-
date copy of the master schedule?

b) Do the QA personnel verify that the study

plan contains the information required for
compliance with the Principles of Good
Laboratory Practice, and is this verification
documented?

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c) Do the QA personnel conduct inspections to

determine if all studies are conducted in
accordance with the Principles of Good
Laboratory Practices?
Do they determine through inspections that
study plans and SOP’s have been made
available to study personnel and are being
followed?
Are records of such inspections (study-
based inspectors, facility-based inspections,
process-based inspections) retained?

d) Do the QA personnel inspect the final

reports to confirm that the methods,
procedures, and observations are accurately
and completely described, and that the
reported results accurately and completely
refelct the raw data of the studies?

e) Do the QA personnel promptly report any

inspection results in writing to the
management and to the Study Director, and
to the Principal Investigator(s) and the
respective management, when applicable?

f) Do the QA personnel 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, and the dates inspection
results were reported to management and
the Study Director and Principal
Investigator(s), if applicable? (This
statement should also serve to confirm that
the final report reflects the raw data).

3. FACILITIES

3.1 General
3.1.1 Is the test facility of suitable size,
construction and locations to meet the
requirements of the study and to minimise
disturbance that would interfere with the
validity of the study?

3.1.2 Does the design of the test facility provide an

adequate degree of separation of the
different
activities to assure the proper conduct of the
study?

3.2 Test system Facilities

3.2.1 Does the test facility have a sufficient number
of rooms or areas to assure the isolation of
test
systems and the isolation of individual
projects,
involving substances or organisms known to
be
or suspected of being biohazardous?

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.2.2 Are suitable rooms or areas available for the

diagnosis, treatment and control of diseases,
in order to ensure that there is no
unacceptable degree of deterioration of test
systems?

3.2.3 Are there storage rooms or areas as needed

for supplies and equipment?
Are these separated from rooms or areas
housing the test systems and is adequate
protection provided against infestation,
contamination and/or deterioration?

3.3 Facilities for Handling Test and Reference

Items
3.3.1 To prevent contamination or mix-ups, are
there separate rooms or areas for receipt
and storage of the test and reference items,
and for the mixing of the test items with a
vehicle?

3.3.2 Are the storage rooms or areas separate

from
rooms or areas containing the test systems?
Are they adequate to preserve identity,
concentration, purity and stability, and to
ensure safe storage for hazardous
substances.

3.4 Archive Facilities

Are achieve facilities provided for the secure
storage and retrievel of study plans, raw
data,
final reports, samples of test items and
specimens?
Does the archives design and conditions
protect the contents from untimely
deteriation?

3.5 Waste Disposal

Is the handling and disposal of wastes
carried
out in such a way that the integrity of studies
is
not jeopardised?
(This includes provision for appropriate
collection, storage and disposal facilities, and
decontamination and transportation
procedures)

4. APPARATUS, MATERIALS AND REAGENTS

4.1 Is the apparatus (including validated

computerised systems) used for the
generation, storage, and retrieval of data,
and for controlling environmental factors
relevant to the study, suitably located and of
appropriate design and adequate capacity?

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4.2 Is the apparatus used in a study periodically

inspected, cleaned, maintained and
calibrated according to SOP’s?
Are records of these activities maintained?
Is calibration, where appropriate, traceable to
national or international standards of
measurement?

4.3 Does the apparatus and materials used in a

study interfere adversely with the test
systems?

4.4 Are chemicals, reagents and solutions

labelled to indicate identity (with
concentration if appropriate), expiry date and
specific storage instructions?
Is information concerning source, preparation
date and stability available?
(The expiry date may be extended on the
basis of documented evaluation or analysis)

5. TEST SYSTEMS

5.1 Physical/Chemical
Is the apparatus used for the generation of
physical/chemical data suitably located and
of appropriate design and adequate
capacity?

5.1.1 Is the integrity of physical/chemical data

suitably located and of appropriate design
and adequate capacity?

5.1.2 Is the integrity of the physical/chemical test

systems ensured?

5.2 Biological
5.2.1 Are proper conditions established and
maintained for the storage, housing,
handling and care of biological test systems,
in order to ensure the quality of the data?

5.2.2 Are newly received animal and plant test

systems isolated until their health status has
been evaluated?
If any unusual mortality or morbidity occurs,
is the lot excluded from use in the studies,
and, when appropriate, humanely destroyed?
At the experimental starting date of a study,
are test systems checked to ensure that they
are free of any disease or condition that
might interfere with the purpose or conduct of
the study?
Are test systems that become diseased or
injured during the course of the study isolated
and treated, if necessary, to maintain the
integrity of the study?
Is all diagnosis and treatment of any disease
before or during a study recorded?

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5.2.3 Are records maintained of source, date of

arrival, and arrival conditions of test
systems?

5.2.4 Are biological test systems acclimatised to

the test environment for an adequate period
before the first administration or application
of the test or reference item?

5.2.5 Does all the information needed to properly

identify the test systems appear on their
housing or containers?
Do individual test systems that are to be
removed from their housing or containers
during the conduct of the study bear
wherever possible appropriate identification?

5.2.6 During use, are housing or containers for test

systems cleaned and sanitised at appropriate
intervals?
Is any material that comes into contact with
the test system free of contaminants at
levels that would interfere with the study?
Is bedding for animals changed as required
by sound husbandry practice?
Is the use of pest control agents
documented?

5.2.7 Are test systems used in field studies located

so as to avoid interference in the study from
spray drift and from past usage of
pesticides?

6. TEST AND REFERENCE ITEMS

6.1 Receipt, Handling, Sampling and Storage

6.1.1 Are records maintained of test item and
reference item characterisation, date of receipt,
expiry date, and quantities received and used
in studies?

6.1.2 Are handling, sampling and storage

procedures identified in order that the
homogearity and stability are assured to the
degree possible and contamination or mix-up
are precluded?

6.1.3 Do storage container(s) carry identification

information, expiry date, and specific storage
instructions?
6.2 Characterisations
6.2.1 Is each test and reference system
appropriately identified e.g. code, CAS number,
name, biological parameters?

6.2.2 For each study, is the identity, including batch

number, purity, composition, concentrations, or
other characteristics to appropriately define
each batch of the test or reference times,
known?

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6.2.3 In cases where the test item is supplied by the

sponsor, is there a mechanism developed in
co-operation between the sponsor and the test
facility, to verify the identity of the test item
subject to the study?

6.2.4 Is the stability of test and reference items

under storage and test conditions known for all
studies?

6.2.5 If the test item is administered or applied in a

vehicle, is the homogeneity, concentration and
stability of the test item in that vehicle
determined?
(For test items used in field studies (e.g. tank
mixes), these may be determined through
separate laboratory experiments)

6.2.6 Is a sample for analytical purposes taken from

each batch of test items retained for all studies
except short-term studies?

7. STANDARD OPERATING PROCEDURES

7.1 Does the test facility have management

approved written SOP’s intended to ensure the
quality and integrity of the data generated by
that test facility?
Are revisions to Sop’s approved by the test
facility management?

7.2 Does each separate test facility unit or area

have immediately available current SOP’s
relevant to the activities being performed
therein? (Published text books, analytical
methods, articles and manuals may be used as
supplements to these SOP’s)

7.3 Are deviations from SOP’s related to the study

documented, and acknowledged by the Study
Director and the Principal Investigator(s), as
applicable?

7.4 Are SOP’s available for, but not limited to, the
following categories of test facility activities (the
details given under each heading are to be
considered as illustrative examples?):

7.4.1 Test and Reference Items

Receipt, identification, labelling, handling,
sampling and storage.

7.4.2 Apparatus, Materials and Reagents

a) Apparatus
Use, maintenance, cleaning and calibration.

b) Computerised systems
Validation, operation, maintenance, security,
changes control and back-up.

c) Materials, Reagents and Solutions

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Preparation and labelling.

7.4.3 Record-keeping, Reporting, Storage and

Retrieval
Coding of studies, data collection, preparation
of reports, indexing systems, handling of data,
including the use of computerised systems.

7.4.4 Test System (where appropriate)

a) Room preparations and environmental room

conditions for the test system.
Siting and placement of test systems in test
plots.

b) Procedures for receipt, transfer, proper

placement, characterisation, identification and
care of the test system.

c) Test system preparation, observations and

examinations, before, during, and at the
conclusion of the study.

d) Handling of test system individuals found

moribund or dead during the study.

e) Collection, identification and handling of

specimens including necropsy and
histopathology.

f) Siting and placement of test systems in test

plots.

7.4.5 Quality Assurance Procedures

Operation of Quality Assurance personnel in
planning, scheduling, performing, documenting
and reporting inspections.

8. PERFORMANCE OF THE STUDY

8.1 Study Plan

8.1.1 Does a written plan exist prior to the initiation of
each study?
Is the study plan approved by dated signature
of the Study Director and verified for GLP
compliance by QA
personnel as specified in Section 2.2.1(b)?
Is the study plan approved by the test facility
management and the sponsor, if required by
national regulation or legislation in the country
where the study is being performed?

8.1.2 Are amendments to the study plan justified and

a) approved by dated signatures of the Study
Director and maintained with the study plan?

b) Are deviations from the study plan described,

explained, acknowledged and dated in a timely
fashion by the Study Director and/or Principal
Investigator(s) and maintained with the study
raw data?
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8.1.3 For short-term studies, is the general study

plan accompanied by a study specific
supplement? (Optional)

8.2 Content of the Study Plan

Does the study plan contain at least the
following information?:

8.2.1 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, biological parameters,
etc.)

d) The reference item to be used.

8.2.2 Information Concerning the Sponsor and 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 phases of the study
delegated by the Study Director and under the
responsibility of the Principal Investigator(s).

8.2.3 Dates
a) The date of approval of the study plan by
signature of the Study Director.
The date of approval of the study plan by
signature of the test facility management and
sponsor, if required by national regulation or
legislation.

b) The proposal experimental starting and

completion dates.

8.2.4 Test Methods

Reference to the OECD Guideline or other test
guideline or method to be used.

8.2.5 Issues (where applicable)

a) The justification for selection of the test

system.

b) Characterisation of the test system, such as

the species, strain, substrain, source of supply,
number, body weight range, sex, age, and
others pertinent information.

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c) The method of administration and the reasons

for its choice.

d) The dose levels and/or concentration,

frequency, and durations of
administration/application.

e) Detailed information on the experimental

design, including a description of the
chronological procedure of the study, all
methods, materials and conditions, type and
frequency of analysis, measurements,
observations and examinations to be
perfromed, and statistical methods to be used
(if any).

8.2.6 Records
A list of records to be retained.

8.3 Conduct of the Study

8.3.1 Is a unique identification given to each study,
and do all items concerning that study carry
this identification?
Are specimens from the study identified to
confirm their origin? (Such identification should
enable traceability, as appropriate for the
specimen and study).

8.3.2 Is the study conducted in accordance with the

study plan?

8.3.3 Are all data generated during the conduct of

the study recorded directly, promptly,
accurately, and legibly by the individual
entering the data, and have all entries been
signed or initialled and dated?

8.3.4 Are any changes in the raw data made so as

not to obscure the previous entry and have the
reasons for the changes been indicated, and
dated and signed?

8.3.5 Is data generated as a direct computer input

identified at the time of data input by the
individual(s) responsible for direct data entries?
Does computerised system design 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 data with the persons
having made these changes, for example, by
use of timed and dated (electronic) signatures).
Are the reasons for the changes given?

9. REPORTING OF STUDY RESULTS

9.1 General
9.1.1 Is a final report prepared for each study? (In
the case of short-term studies, a standardised
final report accompanied by a study specific
extension may be prepared).
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9.1.2 Are reports of Principal Investigators or

scientists involved in the study signed and
dated by them?

9.1.3 Is the final report signed and dated by the

Study Director to indicate acceptance of
responsibility for the validity of the data?
Is the extent of compliance with GLP principles
indicated?

9.1.4 Are corrections and additions to a final report

made in the form of amendments, and do such
amendments clearly specify the reason(s) for
the corrections or additions and are they
signed and dated by the Study Director?

9.1.5 (Reformatting of the final report to comply with

the submission requirements of a national
registration or regulation authority does not
constitute a correction, addition or amendment
to the final report).

9.2 Content of the Final Report

Does the final report contain at least the
following information:

9.2.1 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, biological parameters,
etc).

c) Identification of the reference item by name.

d) Characterisation of the test item, including

purity, stability and homogeneity.

9.2.2 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.

9.2.3 Dates
Experimental starting and completion dates.

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9.2.4 Statement
A QA Programme 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 the raw date)

9.2.5 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.

9.2.6 Results

a) 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 statistical
significance.

d) An evaluation and discussion of the results,

and, where appropriate, conclusions.

9.2.7 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.

10. STORAGE AND RETENTION OF RECORDS AND MATERIALS

10.1 Have the following been retained in the

archives for the period specified by the
appropriate authorities?:

a) The study plan, raw data, samples of test and

reference items, specimens, and the final
report of each study.

b) Records of all inspections performed by the QA

Programme, as well as master schedules.

c) Records of qualifications, training, experience

and job descriptions of personnel.

d) Records and reports of the maintenance and

calibration of apparatus.

e) Validation documentation for computerised

systems.

f) The historical file of all SOP’s.

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g) Environmental monitoring records.

(In the absence of a required retention period,

the final disposition of any study materials
should be documented. When samples of test
and reference items and specimens are
disposed of before the expiry of the required
retention period for any reason, this should be
justified and documented. Samples of test and
reference items and specimens should be
retained only as long as the quality of the
preparation permits evaluation.

10.2 Is the material contained in the archives

indexed so as to facilitate orderly storage and
retrieval?

10.3 Is access to the archives limited to only

personnel authorised by The management?
Is movement of material in and out of the
archives properly recorded?

10.4 Is there a documented procedure for the

transfer of material stored in the test facility
archives to the archives of the sponsor(s) of
the study(s), should the test facility go out of
business and has no legal successor?

11. STUDY AUDITS

NB. In a Study Audit the objective should be to

reconstruct the study by comparing the final
report with the study plan, relevant SOP’s, raw
data, and other archived material.
In some cases, Inspectors may need
assistance from other experts in order to
conduct an effective Study Audit, e.g., where
there is a need to examine tissue sections
under the microscope.

11.1 Have you, as Inspector conducting the Study

Audit:

a) Obtained names, job descriptions and

summaries of training and experience for
selected personnel engaged in the study, such
as the Study Director and principal scientists?

b) Checked that there is sufficient staff trained in

relevant areas for the study undertaken?

c) Identified individual items of apparatus or

special equipment used in the study, and
examined the calibration, maintenance and
service records for these items?

d) Reviewed the records relating to the stability of

the test substances, analyses of test substance
and formulations, analyses of feed, etc.?

e) Attempted to determine, through the interview

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process if possible, the work assignments of

selected individuals participating in the study to
ascertain if these individuals had the time to
accomplish the tasks specified in the study
plan or report?

f) Obtained copies of all documentation

concerning control procedures or forming
integral parts of the study, including:

(i) the study plan;

(ii) SOP’s in use at the time the study

was done;

(iii) log books, laboratory notebooks, files,

worksheets, printouts of computer-
stored
data, etc. Check calculations, where
appropriate;

(iv) the final report?

g) If animals were used in the study, have you

followed a certain percentage of individual
animals from their arrival at the test facility to
autopsy?
Have you checked the records relating to:

(i) animal body weight, food/water intake,

dose formulation and administration,
etc;

(ii) clinical observations and autopsy

findings;

(iii) clinical chemistry;

(iv) pathology?

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Additional/General Comments

Signed :
Lead Inspector / Date
Technical Expert

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