Exercise on GLP

1. GLP is a Quality system concerned with the organisational process and the
conditions under which ………………… health and environmental safety studies.
2. All GLP texts, irrespective of their origin, stress the importance on which of the
five points?
3. What are the GLPs?
a. A set of rules any lab should follow.
b. The code of federal regulations for non-clinical laboratory studies.
c. Code of conduct for principal investigators on a non-GLP study.
d. None of the above.

4. What are the two main goals of the GLPs?

a. To make life difficult for study personnel.
b. To ensure accountability.
c. To ensure ability to reconstruct the study.
d. To ensure mistakes and errors do not occur.

5. What is a consequence of non-compliance of the FDA GLPs?

a. A warning letter will be issued.
b. A 483 may be written during the audit.
c. The facility may face disqualification.
d. All of the above.
e. None of the above.

6. Who is the person or party who initiates and supports a nonclinical study, by
financial or other resources, and submits it to the FDA in support of an
application for a research or marketing permit?
a. The study director.
b. The test facility.
c. The sponsor.
d. The principal investigator.

7. Who has the overall responsibility for the technical conduct of the study as
well as the interpretation, analysis, documentation and reporting of results,
and represents the single point of study control?
a. The principal investigator.
b. Test facility management.
c. The study director.
d. Quality assurance.
8. What is the main function of Quality Assurance in GLP studies?
a. To act as a police force during studies.
b. To help the study personnel perform study work.
c. To catch every mistake that happens in a study.
d. To monitor the effectiveness of quality control program of a study.
9. In GLP labs which of the following is maintained
a. Qualification & Experienced is asked
b. Qualification & Experienced is asked & copy of certificates is retained.
c. Qualification is not required only Experience is required.
d. Only Experience certificate is retained.
10. The GLP system maintains
a. Final results sheet & its records
b. Final results sheet & raw data records.
c. Graph & Charts of analysis.
d. All of the above.
11. The system of GLP recommends
a. Instruments & staff in one room
b. Instruments & staff separately
c. One analyst to sit in instrument room.
d. One analyst to sit in each instrument room.
12. Reference material & other purchased material required under GLP have
a. Any specification.
b. Meeting the specified requirement
c. No material is required.
d. All of the above.
13. A lab assistant was found to have lunch in the instrument room. It is
a. Acceptable
b. Not acceptable
c. Depends on In charge
d. No guidelines under GLP
14. A reagent bottle was marked EDTA solution on the rack in the lab. Which of the
following information is not marked as per GLP-
a. Concentration
b. Date of preparation
c. Prepared by
d. All of the above.
15. In the lab the reference material are kept
a. Lock & key properly capped & recorded
b. Kept on lab rack accessible to any personnel recorded
c. Kept in fridge uncapped & recorded.
d. Kept on weighing balance table & recorded.