This ppt is about Good laboratory practice GLP

2.  PREPARED BY: ILYAS AHAMD
 M.Phil Scholar
 SIYAR KHAN
 M.Phil Scholar

3. GOOD LABORATORY PRACTICE
 Medicines and Healthcare products Regulatory Agency-US which
defines GLP as: “Good Laboratory Practice (GLP) embodies a
set of principles that provides a framework within which
laboratory studies are planned, performed, monitored, recorded,
reported and archived”.
 GOOD LABORATORY PRACTICE applies to non-clinical
studies conducted for the assessment of the safety or efficacy of
chemicals (including pharmaceuticals).
 GLP, a data quality system, should not be confused with standards for
laboratory safety – appropriate gloves, glasses & clothing to
handle lab materials safely.

4. An internationally recognized definition of GLP:
“Good Laboratory Practice (GLP) embodies a set of principles
that provides a framework within which laboratory studies are
planned, performed, monitored, recorded, reported and
archived”.
These studies are undertaken to generate data by which the
hazards and risks to users, consumers and third parties,
including the environment, can be assessed for pharmaceuticals
(only preclinical studies), agrochemicals, cosmetics, food
additives, feed additives and contaminants, novel foods etc.
GLP helps assure regulatory authorities that the data submitted
are a true reflection of the results obtained during the study and
can therefore be relied upon when making risk/safety
assessments.
GLP is an FDA regulation.

5. History
The term GLP was first used in New Zealand in 1972.
• GLP was first introduced in New Zealand and Denmark in 1972, and later
in the US in 1978 in response to the Industrial BioTest Labs scandal.
• GLP is a formal regulation that was created by the US FDA (United states
food and drug administration) in 1978.
• GLP was instituted in US following cases of fraud generated by
toxicology labs in data submitted to the FDA by pharmaceutical
companies. As a result of these findings, FDA promulgated the Good
Laboratory Practice (GLP) Regulations, 21 CFR part 58, on December 22, 1978
(43 FR 59986). The regulations became effective June 1979.
• Assure the quality and integrity of safety Nonclinical laboratory studies
• Although GLP originated in the United States, it had a world wide
impact.
• Non-US companies that wanted to do business with the United states or
register their pharmacies in the United States had to comply with the United
States GLP regulations.
• They eventually started making GLP regulations in their home countries.
• CFR: Code of Federal regulations

6. History
 In 1981 an organization named OECD (Organization for Economic
Co-operation and Development) produced GLP principles that are
international standard.
 OECD has since helped promulgate GLP to many countries.
 Following Decision C(97),186/Final of the OECD Council, data generated
in the testing of chemicals in one OECD Member Country, in accordance
with OECD Test Guidelines and the Principles of GLP are accepted in all
other OECD Member Countries. OECD: ENV/MC/CHEM(98)17 part two
 GLP is a quality system concerned with the organizational process and
conditions under which non-clinical health and environmental safety
studies are planned, performed, monitored, recorded, archived and
reported.

9. OBJECTIVES OF GLP
 GLP makes sure that the data submitted are a true
reflection of the results that are obtained during the
study.
 GLP also makes sure that data is traceable.
 Promotes international acceptance of tests.

11. GLP Principles
1. Organization and Personnel
Management-Responsibilities
Sponsor-Responsibilities
Study Director-Responsibilities
Principal Investigator-Responsibilities
Study Personnel-Responsibilities
2. Quality assurance program
Quality Assurance Personnel
3. Facilities
Test System Facilities
Facilities for Test and Reference Items
4. Equipment, reagents and Materials
5. Test systems
Physical/Chemical
Biological
6. Test & Reference items
7. Standard operating procedures
8. Performance of Study
Study Plan
Conduct of Study
9. Reporting of results
10. Archival - Storage of Records and
Reports

12. Basic elements in GLP
Personnel
i. Sponsor
ii. Management
iii. Study director
iv. Quality Assurance
 Facility
i. Laboratory Operation
ii. Animal care
iii. Equipment
iv. Reagents
v. Storage
Documents
i. Standard Operating
Protocols
ii. Reports
iii. Archiving
 Test and Control Articles
i. Characterization
ii. Handling
iii. Storage

13. Personnel
• Qualification of personnel:
The assumptions is that in order to conduct GLP studies with right
quality a couple of things are important;
1)There should be sufficient number.
2)The personnel should be qualified.
• Sponsor:
Sponsor: person who initiates and supports non-clinical laboratory
study, a person who submits non-clinical study to FDA or testing
facility that initiates and conducts the study.
• Facility management:
Responsibilities of facility management is well defined. They
designate a study director, as well as assure quality assurance unit is
available, test and control articles are characterized.

14. Study director:
He has overall responsibilities for technical conduct safety
studies, as well as interpretation, analysis, documentation and
reporting of results.
Quality Assurance unit:
The quality assurance unit (QAU) serves an internal control
function. It is responsible for monitoring each study to
assure management that facilities, equipment, personnel,
methods, practices, records, controls, SOPs, final reports (for
data integrity), and archives are in conformance with the
GLP/GALP

15. Instrumentation Validation
• This is a process necessary for any analytical laboratory.
• Equipment shall be adequately inspected, cleaned & maintained
• Equipment used for assessment of data shall be tested, calibrated
and/or standardized
• Scales & balances should be calibrated at regular intervals (usually
ranging from 1-12 months)
• The frequency for calibration, re-validation and testing depends on the
instrument and extent of its use in the laboratory.
• Whenever an instrument’s performance is outside the “control limits”
reports must be discontinued.
• Equipment records should include:
Name of the equipment and manufacturer
Model or type for identification
Serial number
Date equipment was received in the laboratory
Copy of manufacturers operating instruction (s)

16. Important questions to be answered for any
analytical instrument
• What is the equipment being used for?
• Is the instrument within specification and is the
documentation to prove this available?
• If the instrument is not within specifications, how much does it
deviate by?
• If the instrument is not within specifications what action has
been taken to overcome the defect?
• Can the standards used to test and calibrate the instrument
be traced back to national standards?

17. Documents: 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
Routine inspection, cleaning, maintenance, testing and
calibration.
Actions to be taken in response to equipment failure.
Analytical methods
Definition of raw data
Keeping records, reporting, storage, mixing, and retrieval
of data

18. Statistical Procedures for Data
Evaluation
Statistical procedures are not simply chosen from a text book
Practitioners in a particular field may adopt certain standards
which are deemed acceptable within that field.
Regulatory agencies often describe acceptable statistical
procedures.

19. Analyst Certification
 Some acceptable proof of satisfactory training and/or competence with
specific laboratory procedures must be established for each analyst.
 Qualification can come from education, experience or additional
trainings, but it should be documented
 Sufficient people
 Requirements of certification vary
Laboratory Certification
Normally done by an external agency
Evaluation is concerned with issues such as
Adequate space
Ventilation
Storage
Hygiene

20. Specimen/Sample Tracking
 Vary among laboratories
 Must maintain the un-mistakable connection between a set of
analytical data and the specimen and/or samples from which
they were obtained.
 Original source of specimen/sample(s) must be recorded and
unmistakably connected with the set of analytical data.