2. Introduction:
• 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.
• New Zealand and Denmark were the first to introduce GLP In
1972. United States was the next to introduce GLP in response
to the poor scientific practices prevalent in US sound that
time.
• GLP was instituted in US following cases of fraud generated by
toxicology labs in data submitted to the FDA by
pharmaceutical companies.
• Industrial Bio Test Labs (IBT) was the most notable case,
where thousands of safety tests for chemical manufacturers
were falsely claimed to have been performed or were so poor.
3. • 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.
• An international economic organization, the Organization for Economic
Cooperation and Development (OECD) published the principles of GLP in
1981 under the name OECD Guidelines for the Testing of Chemicals that
were internationally accepted.
• In 1981 an organization named OECD (organization for economic co-
operation and development produced GLP principles that are
international standard 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.
4.
5. • National GLP-compliance Monitoring Authority was
established by the Department of Science & Technology
• approval of the Union Cabinet on April 24, 2002
• A provisional member of the OECD for GLP.
• India is an Observer to the OECD Working Group on GIP
• The Authority has trained 33 experts in the country as GLP
inspectors.
6. • GLP in OECD principles is defined as "a quality system
concerned with the organizational process and the
conditions under which non-clinical health and
environmental safety studies are planned, performed,
monitored, recorded, archives and reported“
Why GLP was created:
• GLPS were initially invoked in a relation to
malpractices in the laboratories conducting safety
experiments of medicines.
• In the early 1970.research laboratories in the USA
found doing work in unethical ways like:
• Data generation without conduct of the study.
• Falsification of the laboratory work.
• Replacement of dead animals and fabrication of test
results etc.
7. Objectives of GLP
• GLP makes sure that the data submitted are true reflection of the
results obtained from the studies,
• GLP make sure that the data is traceable,
• Promotes intentional acceptance of tests.
8. Guide lines and Precaution:
Recommended action
• Always wear the appropriate equipment of personal
protection.
• They include an apron, safety glasses. and shoes,
• Read thoroughly the detailed procedure before coming
out the experiment.
• Before starting the experiment, label your material
(tubes, vials, specimens, etc.)
• Check the label on the container before taking out any
substance.
9. Recommended action
• Be well aware of the locations and the operating procedures of
the safety equipment such as safety shower, first aid kit, fire
extinguisher, eyewash etc.
• Use a chemical fume hood for strong acids and other fuming
chemicals and solvents.
• Use the recommended biosafety level containment while
handling microorganisms
10.
11. Recommended action
• Decontaminate your work bench and the equipments handled
after use.
• Decontaminate all the infectious materials before disposing
them off.
• Any spillage, accident, or injury should immediately be reported
to your instructor.
12. Recommended action
• Identify the potentially hazardous materials required for
performing the experiments.
• It is recommended to go through the Material Safety Data Sheet
supplied with the chemicals to understand their potential
hazards and the safe usage.
• A Material Safety Data Sheet is a document provided by the
manufacturer/supplier that contains information about the
potential hazard of the material.
• An MSDS comprises of sections on product information
(product name, names and addresses of manufacturer and
supplier, emergency numbers), ingredients of the material,
physical properties of the material, fire or explosion hazard
data, toxicological data, first aid measures in case of an
accident, and Information on safe handling, usage, storage, and
disposal.
13. Recommended action
You might have observed certain hazard warning symbols, also known
as pictograms, on the chemical containers. These warning symbols
allow immediate identification of the material as a hazard.
14. Prohibited or Not recommended Action
• Do not sit on the laboratory benches.
• Never eat or drink anything inside the laboratory.
• Do not handle your contact lenses or apply cosmetics in the lab.
• Never touch any chemical or reagent with bare hands.
• Never try to taste or smell any chemical or reagent.
• Do not pipette any of the chemicals through your mouth.
• If the chemicals are taken from the original container, and you happen to
take out more than the amount required, never transfer back the excess
amount to the original container.
• If concentrated acids are to be diluted more add water to the
concentrated acid, concentrated acid should be added to the water drop-
wise with continuous stirring.
• Never leave your experiments unattended.
• Never point the open end of any glassware or vial towards yourself or any
other person.
15. Laboratory Notebook
• All scientists have the obligation to prepare written reports of
the results of experiment work.
• Since this record may be studied by many individuals, it must
be completed I a clear, concise, orderly, and accurate manner.
• This means that procedural details, observations, and results
must be recorded in a laboratory notebook while the
experiment is being performed.
17. Advantages of GLP
• Assures that the data are a true reflection of results obtained
from studies,
• Preclinical safety and residue safety,
• Generation of high quality and reliable test data,
• Mutual acceptance of data,
• Increases public confidence,
• Shortens the time to market for new products.
Disadvantages of GLP
• More man power is required.
• Expensive process.
• Time consuming process.
