Basic GLP Quiz By Hardik Panchal (Trainer)

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| By H_pharma

H_pharma

Community Contributor

Quizzes Created: 1 | Total Attempts: 934

Questions: 10 | Attempts: 934 | Updated: Mar 21, 2023

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Basic Glp Quiz By Hardik Panchal (Trainer) - Quiz

Hello Friends,
I am Hardik Panchal, your GLP/GCP trainer.
I have created very interesting quiz and lets refresh our knowledge.
Let's enjoy quiz of Basic GLP (Good Laboratory Practices).
Note: Provide your correct details for your GLP certificate.
Stay Safe, Stay Home.

Questions and Answers

1.

When we talk about GLP. It includes scientific “guidelines” also like Validation Criteria, Analytical Methodologies. True/False.
- A.
  
  True
- B.
  
  False
Correct Answer
B. False

Explanation
Hey Friends, GLP regulations do not include any scientific “guidelines” like Validation Criteria and Analytical Methodologies. There is separate guidelines available for such scientific details.

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2.

As per GLP, who approves SOP?
- A.
  
  Test Facility Management
- B.
  
  Quality Assurance
- C.
  
  Laboratory Director
- D.
  
  SOP Approval Committe
Correct Answer
A. Test Facility Management

Explanation
As per GLP, Test Facility Management approves SOP.

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2
0
3.

He is the individual responsible for the overall technical conduct of the study.
- A.
  
  Study Director
- B.
  
  Study Co-ordinator
- C.
  
  Vice President
- D.
  
  Quality Manager
Correct Answer
A. Study Director

Explanation
Study Director is the individual responsible for the overall technical conduct of the study.

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4.

The Sponsor is responsible for the characterization of the reference material.
- A.
  
  True
- B.
  
  False
Correct Answer
B. False

Explanation
Instead of Sponsor, CRO is responsible for the characterization of the reference material

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5.

Tick on odd one out (Single Answer)
- A.
  
  WHO GLP
- B.
  
  21 CFR part 58
- C.
  
  21 CFR part 11
- D.
  
  Schedule L1
Correct Answer
A. WHO GLP

Explanation
Apart from WHO GLP, provided titles belong to law/rgulation. While WHO GLP is guideline.

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6.

It is mandatory to archive study data as the study progresses.
- A.
  
  True
- B.
  
  False
Correct Answer
B. False

Explanation
It is not mandatory to archive study data as the study progresses. In fact, it is an ideal practice to archive study data at the end of the study.

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7.

Who will ensure that after completion of the regulatory study, the final report, raw data are archived?
- A.
  
  Study Director
- B.
  
  Test Facility Management
- C.
  
  Quality Assurance
- D.
  
  Study Person
Correct Answer
A. Study Director

Explanation
Study Director will ensure that after completion of the regulatory study, the final report, raw data are archived.

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8.

Calibration and Validation both are interchangable terminologies
- A.
  
  True
- B.
  
  False
Correct Answer
B. False

Explanation
Calibration and Validation both are different terminologies

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9.

Control access to study records is known as...............
- A.
  
  Archive Facility
- B.
  
  Document Control
- C.
  
  Secure Storage Facility
- D.
  
  Raw Data Room
Correct Answer
A. Archive Facility

Explanation
Control access to study records is known as Archive Facility.

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Current Version
Mar 21, 2023

Quiz Edited by
ProProfs Editorial Team
Apr 24, 2020

Quiz Created by
H_pharma

Basic Glp Quiz By Hardik Panchal (Trainer)

When we talk about GLP. It includes scientific “guidelines” also like Validation Criteria, Analytical Methodologies. True/False.

As per GLP, who approves SOP?

He is the individual responsible for the overall technical conduct of the study.

The Sponsor is responsible for the characterization of the reference material.

Tick on odd one out (Single Answer)

It is mandatory to archive study data as the study progresses.

Who will ensure that after completion of the regulatory study, the final report, raw data are archived?

Calibration and Validation both are interchangable terminologies

Control access to study records is known as...............