The document discusses Good Laboratory Practice (GLP), which are regulations created by the FDA in 1978 that provide a framework for conducting laboratory studies. In the early 1970s, the FDA discovered many cases of poor laboratory practices in the US, such as uncalibrated equipment providing incorrect measurements. GLP establish responsibilities for management, sponsors, study directors, investigators, and quality assurance personnel. They also provide guidelines for facility design and maintenance, equipment calibration, test system handling and identification, study planning and reporting, and record keeping. The goal of GLP is to ensure the quality and integrity of nonclinical safety data.

1. SUBMITTED BY : HABIBA AYUB
BUTT
S/2012-1922
BS.ED(HONS)SELF-SUPPORT

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3. •
1. ). GLP is an FDA regulation. GLP is a formal regulation that was created by the FDA (United
states food and drug administration) in 1978.
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4. DEFINITION
GLP embodies a set of
principles that provides a
frame work within which
laboratory studies are
planned, performed,
monitored, and archived and
reported.
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5.  • In the early 70’s FDA
became aware of cases
of poor laboratory
practice all over the
United States.
 • They discovered a lot f
a lot of poor lab
practices.
 Like Equipment not
been calibrated to
standard form ,
therefore giving wrong
measurements.
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7. Management responsibilties
Sponsor responsibility
Study-director responsibilities
Principle investigator responsibilities
Study personnel responsibility(people
employed in an organization such as staff)
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8. • Quality Assurance personnel
This is inspection
Three types of inspection. – Study-based
inspections. – Facility-based inspections. –
Process-based inspection
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9. • Suitable size, construction and location. •
Adequate degree of separation of the
different activities.
 • Suitable rooms for the diagnosis,
treatment and control of diseases.
 Storage rooms.
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10. • Apparatus of appropriate design and
adequate capacity.
• Documented Inspection, cleaning,
maintenance and calibration of apparatus.
 • Chemicals, reagent and solutions should
be labeled to indicate identity, expiry and
specific storage instructions.
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11. • 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.
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12. • Receipt, handling, sampling and storage
 • Characterization.
 • Known stability of test and reference
items.
 • Stability of the test item in its vehicle
(container).
 • Samples for analytical purposes for each
batch.
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13. They define how to carry out protocol-
specified activities.
They are written to explain how the
procedures are suppose to work.
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14. 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.
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15. • Information on sponsor and test facility.
 • Experimental starting and completion
dates.
 • A Quality Assurance Program Statement.
 • Description of materials and test
methods.
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16. Storage (samples, reference items, raw
data, final reports) etc.
Index of materials retained(maintainence
of the material)
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17.  • Area should be free from smoke, smell,
dust etc.
• Ensure good ventilation, proper
illumination and prefer natural light.
 • Air conditioned the lab with humidity
control.
 • Enough space for measuring and testing
instrument.
GLPs have heavy emphasis on data
recording, record & specimen retention
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