Notes 1 For 25-03 Good Laboratory Practices PDF

GOOD LABORATORY
PRACTICES
D r. G a u r a v Ti w a r i
GLP: GOOD LABORATORY PRACTICE
• GLP is an FDA regulation.
• GLP is a formal regulation that was created by the FDA
(United states food and drug administration) in 1978.
Definition of GLP
• GLP embodies a set of principles that provides

a frame work within which laboratory studies
are planned performed, monitored, and
archived and reported.
Need for GLP
•In the early 70’s FDA became aware of cases of poor laboratory
practice all over the United States.
They discovered a lot fraudulent activities and a lot of poor

lab practices.
Examples of some of these poor lab practices found were
Equipment not been calibrated to standard form , therefore

giving wrong measurements
Incorrect/inaccurate accounts of the actual lab study.
Inadequate test systems.
OBJECTIVE/PURPOSE
 To promote the development of quality and validity of test data
used for determining the safety of chemicals and chemicals
product.
 Makes sure that the data submitted are a true reflection of the
results that are obtained during the study.
 Promotes international acceptance of tests.
 Also makes sure that data is traceable.
 Help scientists to obtain results which are:
 Reliable
 Repeatable
 Audible
 Recognized by scientists worldwide
MISSION OF GLP
 Test systems
 Archiving of records and materials
 Apparatus, material and reagent facilities
 Quality assurance programs
 Performance of the study
 Reporting of study results
 Standard operating procedures (SOPs)
 Personnel and test facility organization
THE PRINCIPLES OF GLP IN
GENERAL
 Concerned with how we organize our laboratories and how

we organize our studies.
 Addresses responsibilities for managing people, facilities

and equipment for good science
 Concerned with how we plan, perform and report our

experiments and studies
 Importantly it does not interfere with the ability of

scientists to make scientific decision
GLP PRINCIPLES
1. Test facility organization and personnel

2. Quality Assurance (QA) program
3. Facilities
4. Apparatus materials and reagents
5. Test systems
6. Test and reference items
7. Standard Operating Procedures (SOP’s)
8. Performance of the study
9. Reporting of study results
10. Storage and retention of records and materials
Purpose of GLPs:
• GLP is to certify that every step of the analysis is

valid or Not.
• Assure the quality & integrity of data submitted to
FDA in support of the safety of regulated products.
• GLPs have heavy emphasis on data recording,

record & specimen retention.
GOOD LABORATORY
PRACTICES PRINCIPLES.
1. Test Facility Organisation and Personnel.
2. Quality Assurance Programme(QAP).
3. Facilities.
4. Apparatus, Material and Reagents.
5. Test systems.
6. Test and Reference Substances.
7. Standard Operating Procedures(SOP).
8. Performance of The Study.
9. Reporting of Study Results.
10. Storage and Retention of Records and materials.
1.Test Facility Organization and Personnel
Study Personnel Responsibilities
• Should have the Knowledge of the GLP

principles.
• Access to the study plan and appropriate
SOP’s.
• Comply with the instructions of the SOP’s.
• Record raw data.
• Study personnel are responsible for the quality
of their data.
• Exercise health precautions to minimize risk.
• Ensure the integrity of the study.
2.Quality Assurance Program
Responsibilities of the QA Personnel
• Access to the updated study plans and SOP’s.

• Documented verification of the compliance of study
plan to the GLP principles.
• Inspections to determine compliance of the study with
GLP principles.
• Three types of inspection.
– Study-based inspections.
– Facility-based inspections.
– Process-based inspections.
• Inspection of the final reports for accurate and full
description.
• Report the inspection results to the management.
• Statements.
3. Facilities
• Suitable size, construction and location.
• Adequate degree of separation of the
different activities.
• Isolation of test systems and individual
projects to protect from biological
hazards.
• Suitable rooms for the diagnosis,
treatment and control of diseases.
• Storage rooms.
4. Apparatus, Materials and
Reagents
• Apparatus of appropriate design and
adequate capacity.
• Documented Inspection, cleaning,
maintenance and calibration of apparatus.
• Apparatus and materials not to interfere
with the test systems.
• Chemicals, reagent and solutions should be
labeled to indicate identity, expiry and
specific storage instructions.
5. Test Systems
• Physical and chemical test systems.
• Biological test systems.
• Records of source, date of arrival,
and arrival conditions of test systems. •
Proper identification of test systems in
their container or when removed.
• Cleaning and sanitization of containers.
• Pest control agents to be documented.
6. Test and Reference Items
• Receipt, handling, sampling and storage

• Characterization.
• Known stability of test and reference
items.
• Stability of the test item in its vehicle
(container).
• Experiments to determine stability in
tank mixers used in the field studies.
• Samples for analytical purposes for
each batch.
7.Standard Operating
Procedures (SOP)
 Written procedures for a laboratories

program.
 They define how to carry out protocol-
specified activities.
 Most often written in a chronological
listing of action steps.
 They are written to explain how the
procedures are suppose to work.
7.SOP’s
 Routine inspection, cleaning,
maintenance, testing and calibration.
 Actions to be taken in response to
equipment failure.
 Keeping records, reporting, storage,
mixing, and retrieval of data.
 Definition of raw data.
 Analytical methods.
8. Performance of the Study
• Prepare the Study plan.
• Content of the study plan.
› Identification of the study.
› Records.
› Dates.
› Reference to test methods.
› Information concerning the sponsor
and facility.
• Conduct of the study.
9. Reporting of Study Results
• Information on sponsor and test facility.
• Experimental starting and completion
dates.
• A Quality Assurance Program Statement. •

Description of materials and test methods. •
Results.
• Storage (samples, reference items, raw
data, final reports) etc.
10. Storage and Retention of
Records and Materials
– The study plan, raw data, samples.
– Inspection data and master
schedules.
– SOPs.
– Maintenance and calibration data.
– If any study material is disposed of
before expiry the reason to be
justified and documented.
– Index of materials retained.
11. Protocol for and conduct of a
nonclinical laboratory study
1) Protocol
2) Conduct of a nonclinical study

Protocol
Contents of protocol
1.Identification
2.Title and statement of purpose
3.Identification of test(or control) items
4.Names and address of the sponsor, test facility and test site
5.Name of the study director and other personnel
6.Proposed dates
7.Justification for selection of the test system

8.Description of the test system
9. Experimental design
Conduct of a nonclinical laboratory study
1) Study shall be conducted in accordance with the protocol.
2)
Information of the specimens should be present on the
container to avoid error in recording and storage of data.
3)
All the data generated shall be recorded directly, promptly and
legibly by ink.
12. D ISQUALIFICATION OF TESTING FACILITY
Before a workplace can experience the
consequences of noncompliance, an
explanation of disqualification isneeded
The FDA states the purpose of disqualification

as the exclusion of a testing facility from
completing laboratory studies or starting any
new studies due to not following the
standards of compliance set by the Good
Laboratory Practice manual
07/15/13
POSSIBLE VIOLATIONS
Falsifying information for permit, registration

or any required records
Falsifying information related to testing~
protocols, ingredients, observations, data
equipment, etc.
Failure to prepare, retain, or submit written
records required by law
07/15/13 25
UPON D ISQUALIFICATION …
If the commissioner finds that the facility was noncompliant on any of the grounds
after the hearing, then a final order of noncompliance will be sent to the facility with
explanations.
If a testing facility has been disqualified, any studies done before of after the
disqualification will need to be determined asessential to a decision (acceptable ornot)
If the study is determined unacceptable, then the facility itself may need to show that
the study was not affected by the noncompliance that led to the disqualification
Once finally disqualified, the facility may not receive or be considered for a research or
marketing permit and the study is rejected.
The commissioner may notify the public and all interested persons, including other
federal agencies the facility may havecontacted.
The FDA may ask the other agencies to consider whether to support the facility or not
under the disqualification
TheFDA may turn itover to the federal, state or local law enforcement
The facility’s sponsor may terminate or suspend the facility from doing any nonclinical
study forapermit.
The sponsor is required to notify the FDA In writing within 15 working days that the
facility is to be suspendedor terminated andwhy

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GOOD LABORATORY

• GLP embodies a set of principles that provides

They discovered a lot fraudulent activities and a lot of poor

Examples of some of these poor lab practices found were

Equipment not been calibrated to standard form , therefore

 Concerned with how we organize our laboratories and how

 Addresses responsibilities for managing people, facilities

 Concerned with how we plan, perform and report our

 Importantly it does not interfere with the ability of

1. Test facility organization and personnel

• GLP is to certify that every step of the analysis is

• GLPs have heavy emphasis on data recording,

• Should have the Knowledge of the GLP

• Access to the updated study plans and SOP’s.

• Receipt, handling, sampling and storage

 Written procedures for a laboratories

• A Quality Assurance Program Statement. •

2) Conduct of a nonclinical study

7.Justification for selection of the test system

1) Study shall be conducted in accordance with the protocol.

The FDA states the purpose of disqualification

Falsifying information for permit, registration

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