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APU Module 2: Regulatory Expectations Flashcards | StudBud
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APU Module 2: Regulatory Expectations
APU Module 2: Regulatory Expectations
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APU Module 2: Regulatory Expectations
Flashcards
10 cards
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Practice quiz
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Questions
10
Answers
1
Which one is NOT a responsibility of the Quality Unit?
Approving or rejecting changes
Making yearly sales quotas
Investigating errors using Root Cause Analysis
Disposition of materials
2
What is an Annual Product Quality Review?
Proposes changes to product specifications or processes
All choices are correct
Annual written report to evaluate a drug's quality standards
Identifies trends in level of product quality
3
Which of the following is not an example of a regulatory authority?
European Medicines Agency
PDA
FDA
ANVISA
4
Which one is not a Good Documentation Practice?
Documenting at the time of performance
Saving copies of SOPs in your desk
Legible handwritten entries
Reviewing and approving documentation
5
What does cGMP stand for?
Current Good Manufacturing Practices
Championship Games for Military Police
Current Great Moving Practices
Complex Good Manufacturing Principles
6
What is one of the purposes of the cGMPs?
Monitoring of trends in APA
Meet specifications for SQuIPP
SOPs for every step of the process
Products meet chemical specifications
7
Which type of drug application process does our company follow?
ANDA
All answer choices are correct
NDA
IND
8
When conducting inspection of all systems, what regulators look for?
Implementation of operational excellence programs
Written SOPs and adherence to them
The importance of the quality unit
How tests are conducted in manufacturing
9
True or False: Having well-written procedures is the first step to minimizing errors.
True
False
10
True or False: Companies do not have to issue a field alert before a recall is issued.
False
True
