ComplianceOnline FDA Pharma GMP Rules Quiz

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Complianceon1

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Quizzes Created: 7 | Total Attempts: 6,270

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1/6 Questions

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

Complianceonline FDA Pharma GMP Rules Quiz - Quiz

About This Quiz

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

2.

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

A. 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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3.

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

A. 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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4.

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

A. 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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5.

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

A. 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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6.

If samples are taken from the top, middle and bottom of a container, these samples should not be composited.
- True
- 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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Current Version
Mar 22, 2023

Quiz Edited by
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Apr 23, 2014

Quiz Created by
Complianceon1

Complianceonline FDA Pharma GMP Rules Quiz

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

Quiz Preview

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

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

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

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

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