OECD Principle Of Good Laboratory Practice (GLP).pptx

OECD Principle Of Good
Laboratory Practice (GLP)
SIRAJUDDIN MOLLA
Research scholar
DEPARTMENT OF PHARMACOLOGY
SPER, JAMIA HAMDARD

CONTENT
 Introductions
 Scope
 Definitions of Terms
 Good laboratory practice principles

 The Organisation for Economic Co-operation and Development (OECD) is an
intergovernmental organisation in which representatives of 29 industrialised
Introductions

 The Principles of Good Laboratory Practice (GLP) have been developed to
promote the quality and validity of test data used for determining the safety
safety of chemicals and chemicals products.
 In 1979 and 1980, an international group of experts established under the
Special Programme on the Control of Chemicals developed the “OECD
Principles of Good Laboratory Practice” (GLP), utilizing common managerial
and scientific practices and experience from various national and
international sources.
 These Principles of GLP were adopted by the OECD Council in 1981, as an
Annex to the Council Decision on the Mutual Acceptance of Data in the
Assessment of Chemicals.
Contd…

Those Principles of GLP were formally recommended for use in Member
countries by the OECD Council in 1981.
The Revised OECD Principles of GLP were reviewed in the relevant policy
bodies of the Organisation and were adopted by Council on 26th November,
1997
The GLP regulations for non-clinical laboratory studies published by the US
Food and Drug Administration in 1976 provided the basis for the work of the
Expert Group, which was led by the United States and comprised experts from
the following countries and organisations:
Australia, Austria, Belgium, Canada, Denmark, France, the Federal Republic
of Germany, Greece, Italy, Japan, the Netherlands, New Zealand, Norway,
Sweden, Switzerland, the United Kingdom, the United States, the Commission
of the European Communities, the World Health Organisation and the
International Organisation for Standardisation.
Contd…

 These Principles of Good Laboratory Practice should be applied to the
non-clinical safety testing of test items contained in pharmaceutical
products, pesticides, cosmetics, veterinary drugs as well as food
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.
 The purpose of testing these test items is to obtain data on their
properties and/or their safety with respect to human health and/or the
environment.
 Non-clinical health and environmental safety studies covered by the
Principles of Good Laboratory Practice include work conducted in the
laboratory, in greenhouses, and in the field.
Scope

 Unless specifically exempted by national legislation, these Principles of GLP
apply to all non-clinical health and environmental safety studies
regulations for the purpose of registering or licensing
- pharmaceuticals
- pesticides, food and feed additives
- cosmetic products
- veterinary drug products and similar products and
- for the regulation of industrial chemicals.
Contd…

1. Good Laboratory Practice
 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
 Test facility means the persons, premises and operational unit(s) that are
necessary for conducting the non-clinical health and environmental safety
study.
 For multi-site studies, those which are conducted at more than one site, the
test facility comprises the site at which the Study Director is located and all
individual test sites, which individually or collectively can be considered to be
be test facilities.
Definitions of Terms

3. Terms Concerning the Non-Clinical Health and Environmental
Safety Study
 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.

Good laboratory practice principles
1. Test Facility Organisation and Personnel
2. Quality Assurance Programme
3. Facilities
4. Apparatus, Material, and Reagents
5. Test Systems
6. Test and Reference Items
7. Standard Operating Procedures
8. Performance of the Study
9. Reporting of Study Results
10. Storage and Retention of Records and Materials

 Ensure that a sufficient number of qualified personnel, appropriate facilities,
equipment, and materials are available for the timely and proper conduct of
the study;
 Ensure the maintenance of a record of the qualifications, training, experience
and job description for each professional and technical individual;
 Ensure that appropriate and technically valid Standard Operating Procedures
are established and followed, and approve all original and revised Standard
Operating Procedures;
 Ensure that test facility supplies meet requirements appropriate to their use
in a study;
1. Test Facility Organisation and Personnel
1.1 Test Facility Management’s
Responsibilities

1.2 Study Director’s Responsibilities
1. The Study Director is the single point of study control and has the
responsibility for the overall 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 computerised systems used in the study have been
validated;

1.3 Principal Investigator’s Responsibilities
The Principal Investigator will 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
 All personnel involved in the conduct of the study must be knowledgeable in
those parts of the Principles of Good Laboratory Practice which are
applicable to their involvement in the study.
• Study personnel will have access to the study plan and appropriate SOPs.
• All study personnel are responsible for recording raw data promptly and accurately
and in compliance with these Principles of GLP.
• Study personnel should exercise health precautions to minimise risk to themselves
and to ensure the integrity of the study.

2. Quality Assurance Programme
2.1. General
a) The test facility should have a documented Quality Assurance Programme to
assure that studies performed are in compliance with these Principles of
Good Laboratory Practice.
b) The Quality Assurance Programme should be carried out by an individual or
by individuals designated by and directly responsible to management and
who are familiar with the test procedures.
c) This individual(s) should not be involved in the conduct of the study being
assured.

2.2. Responsibilities of the Quality Assurance Personnel
 The responsibilities of the Quality Assurance personnel include, but are not
limited to, the following functions. They should:
• 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;
• verify that the study plan contains the information required for
compliance with these Principles of GLP. This verification should be
documented;
• conduct inspections to determine if all studies are conducted in
accordance with these Principles of GLP. Inspections should also
determine that study plans and SOPs have been made available to study
Contd…

• Inspections can be of three types as specified by Quality Assurance
Programmed Standard Operating Procedures:
- Study-based inspections,
- Facility-based inspections,
- Process-based inspections.
Records of such inspections should be retained.
• 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 reflect the raw data of the studies;
Contd…

3. Facilities
3.1. General
 The test facility should be of suitable size, construction and location to meet
the requirements of the study and to minimise disturbance that would
interfere with the validity of the study.
 The design of the test facility should provide an adequate degree of
separation of the different activities to assure the proper conduct of each
study.

3.2. Test System Facilities
 The test facility should 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.
 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.
 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 and should provide adequate protection
against infestation, contamination, and/or deterioration.
Contd…

3.3. Facilities for Handling Test and Reference Items
 To prevent contamination or mix-ups, there should be separate rooms or
areas for receipt and storage of the test and reference items, and mixing of
the test items with a vehicle.
 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.
Contd…

3.4. Archive Facilities
Archive facilities should be provided for the secure storage and retrieval of
study plans, raw data, final reports, samples of test items and specimens.
Archive design and archive conditions should protect contents from untimely
deterioration.
3.5. Waste Disposal
Handling and disposal of wastes should be carried out in such a way as not to
jeopardise the integrity of studies. This includes provision for appropriate
collection, storage and disposal facilities, and decontamination and
transportation procedures.
Contd…

4. Apparatus, Material, and Reagents
 Apparatus, including validated computerised systems, used for the
generation, storage and retrieval of data, and for controlling environmental
factors relevant to the study should be suitably located and of appropriate
design and adequate capacity.
 Apparatus used in a study should be periodically inspected, cleaned,
maintained, and calibrated according to Standard Operating Procedures.
Records of these activities should be maintained. Calibration should, where
appropriate, be traceable to national or international standards of
measurement.

 Apparatus and materials used in a study should not interfere adversely with
the test systems.
 Chemicals, reagents, and solutions should be labelled to indicate identity
(with concentration 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.

5.1 Physical/Chemical
 Apparatus used for the generation of physical/chemical data should be
suitably located and of appropriate design and adequate capacity.
 The integrity of the physical/chemical test systems should be ensured.
5.2 Biological
 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.
5. Test Systems

 Newly received animal and plant test systems should be isolated until their
health status 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.
 All information needed to properly identify the test systems should appear
on their housing 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.

6.1 Receipt, Handling, Sampling and Storage
 Records including test item and reference item characterisation, date of
receipt, expiry date, quantities received and used in studies should be
maintained.
 Handling, sampling, and storage procedures should be identified in order
that the homogeneity and stability are assured to the degree possible and
contamination or mixup are precluded.
 Storage container(s) should carry identification information, expiry date, and
specific storage instructions.
6. Test and Reference Items

6.2 Characterisation
 Each test and reference item should be appropriately identified (e.g., code,
Chemical Abstracts Service Registry Number (CAS number), name, biological
parameters).
 For each study, the identity, including batch number, purity, composition,
concentrations, or other characteristics to appropriately define each batch of
the test or reference items should be known.
 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 identity of the test item subject to the study.
 The stability of test and reference items under storage and test conditions
should be known for all studies.

7.1. 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 by that test facility. Revisions to Standard
Operating Procedures should be approved by test facility management.
7.2. 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.
7.3. 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.
7. Standard Operating Procedures

8.1 Study Plan
1. For each study, a written study plan should exist prior to the initiation of the
study, approved by dated signature of the Study Director and verified for
GLP compliance by Quality Assurance personnel.
The study plan should also be 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.
2.a. Amendments to the study plan should be justified and approved by
dated signature of the Study Director and maintained with the study
plan.
2.b. Deviations from the study plan should be described, explained,
acknowledged and dated in a timely fashion by the Study Director
and/or Principal Investigator(s) and maintained with the study
8. Performance of the Study

8.2 Content of the Study Plan
The study plan should contain, but not be limited to the following 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,
biological parameters, etc.);
d) The reference item to be used.
3. For short-term studies, a general study plan accompanied by a study specific
supplement may be used.

2. Information Concerning the Sponsor and the Test Facility
3. Dates
4. Test Methods
5. Issues (where applicable)
6. Records

8.3 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 initialled 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 initialled by the individual 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.

9.1 General
1. A final report should be prepared for each study. In the case of short term
studies, a standardised 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 with these 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 a national
registration or regulatory authority does not constitute a correction, addition or amendment
to the final report.
9. Reporting of Study Results

9.2 Content of the Final Report
The final report should include, but not be limited to, the following
information:
1. Identification of the Study, the Test Item and Reference Item
2. Information Concerning the Sponsor and the Test Facility
3. Dates
 Experimental starting and completion dates.
4. Statement
 A Quality Assurance 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 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. 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.
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.

10.1 The following should be 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 Quality Assurance
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;
10. Storage and Retention of Records
and Materials

10.2 Material retained in the archives should be indexed so as to facilitate
orderly storage and retrieval.
10.3 Only personnel authorised by management should have access to the
archives. Movement of material in and out of the archives should
be properly recorded.
10.4 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 the study(s).

1. https://ntp.niehs.nih.gov/iccvamsuppdocs/feddocs/
oecd/oecd_glp
2. https://www.slideshare.net/GagandeepJaiswal/oecd
-principles-of-good-laboratory-practice
References

OECD Principle Of Good Laboratory Practice (GLP).pptx

OECD Principle Of Good Laboratory Practice (GLP).pptx

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