ComplianceOnline FDA Pharma GMP Rules Quiz

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| By Complianceon1

Complianceon1

Community Contributor

Quizzes Created: 7 | Total Attempts: 6,125

Questions: 6 | Attempts: 821 | Updated: Mar 22, 2023

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This short quiz tests you on your knowledge of the FDA's GMP rules for finished pharmaceuticals and APIs.

Questions and Answers

1.

What should be used to identify permanent pipework in a manufacturing facility?
- A.
  
  Documentation
- B.
  
  Computer Systems
- C.
  
  Both of the Above
- D.
  
  None of the above
Correct Answer
C. Both of the Above

Explanation
Both documentation and computer systems should be used to identify permanent pipework in a manufacturing facility. Documentation can provide detailed information about the pipework, such as its location, purpose, and specifications. Computer systems can be used to store and track this information, making it easily accessible and searchable. By utilizing both methods, the facility can ensure accurate and up-to-date identification of the permanent pipework, facilitating maintenance, repairs, and overall management of the facility.

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2.

An employee need only be given training when he first assumes responsibility.
- A.
  
  True
- B.
  
  False
Correct Answer
B. False

Explanation
This statement is false because training should not be limited to just when an employee first assumes responsibility. Training should be an ongoing process throughout an employee's tenure to ensure they have the necessary skills and knowledge to perform their job effectively. Continuous training helps employees stay updated with new technologies, industry trends, and best practices, allowing them to adapt to changing circumstances and improve their performance over time.

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3.

If samples are taken from the top, middle and bottom of a container, these samples should not be composited.
- A.
  
  True
- B.
  
  False
Correct Answer
A. True

Explanation
When samples are taken from different parts of a container, it is important not to composite them. This means that the samples should not be mixed together. This is because the samples taken from different parts of the container may have different characteristics or contaminants. By keeping the samples separate, it allows for a more accurate analysis of each individual sample and provides a better understanding of the overall contents of the container.

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4.

Deviation and investigation reports must be reviewed after a batch has been released.
- A.
  
  True
- B.
  
  False
Correct Answer
B. False

Explanation
Deviation and investigation reports should be reviewed before a batch is released, not after. This is to ensure that any issues or deviations from standard procedures are addressed and resolved before the batch is released for distribution or use. Reviewing these reports after the batch has been released would be counterproductive and could lead to potential risks or quality issues going unnoticed. Therefore, the given statement is false.

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5.

Non-calibrated equipment can be used in the pharma manufacturing facilities
- A.
  
  True
- B.
  
  False
Correct Answer
B. False

Explanation
Non-calibrated equipment should not be used in pharma manufacturing facilities. Calibrated equipment is necessary to ensure accurate and reliable measurements, which are crucial in pharmaceutical manufacturing to maintain quality and safety standards. The use of non-calibrated equipment can lead to inaccurate results, compromised product quality, and potential risks to patient health. Therefore, it is important to use calibrated equipment in pharma manufacturing facilities.

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6.

Returned drugs must be quarantined in a specific, demarcated area kept separate from the rest of the stored products.
- A.
  
  True
- B.
  
  False
Correct Answer
A. True

Explanation
Returned drugs need to be quarantined in a specific, demarcated area to ensure they are kept separate from other stored products. This is important to prevent any potential contamination or mixing of the returned drugs with the regular stock. By quarantining them, it allows for proper inspection, verification, and appropriate disposal or reintegration into the inventory if deemed safe. This practice helps maintain the integrity and safety of the stored products and ensures compliance with regulations and quality control measures.

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Current Version
Mar 22, 2023

Quiz Edited by
ProProfs Editorial Team
Apr 23, 2014

Quiz Created by
Complianceon1

Complianceonline FDA Pharma GMP Rules Quiz

What should be used to identify permanent pipework in a manufacturing facility?

An employee need only be given training when he first assumes responsibility.

If samples are taken from the top, middle and bottom of a container, these samples should not be composited.

Deviation and investigation reports must be reviewed after a batch has been released.

Non-calibrated equipment can be used in the pharma manufacturing facilities

Returned drugs must be quarantined in a specific, demarcated area kept separate from the rest of the stored products.