Are You Smarter Than An Ora Inspector? Test Your Knowledge Of Aseptic Cgmps

8 Questions | By Agnesshanley | Last updated: Mar 19, 2022 | Total Attempts: 118

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How do FDA plant inspectors select the best categories for noting observations on 483's? This quiz focuses on 21 CFR 211. 192 and 21 CFR 211. 113(b). Choose the best answer to each question. Your test will be graded as you take it. If you receive a perfect score, please write in via the "Comments" section and let us know. You will be sent a prize.

Questions and Answers

1.

21 CFR Part 211 only relates to finished drug products
- A.
  
  All of the time
- B.
  
  Some of the time
- C.
  
  Never
2.

Can different sections of 21 CFR Part 211 be cited by an Investigator when issuing a single Observation to a pharmaceutical company?
- A.
  
  Yes, it is possible to interchange many sections within Part 211
- B.
  
  No, only a single section of Part 211 can be used with a specific type of observation (e.g. 21 CFR Part 211.113(b)
- C.
  
  Only in selected instances
3.

What is the meaning of the phrase "whether or not the batch has already been distributed?"
- A.
  
  The lot at hand would be extensively investigated
- B.
  
  The lots distributed would be extensively evaluated
- C.
  
  Both A and B
4.

Why is there a 21 CFR 211.113(a) and a 21 CFR 211.113(b)? 21 CFR 211.113(a) refers to which of the following?
- A.
  
  Contamination of products not required to be sterile
- B.
  
  Contamination of products required to be sterile
- C.
  
  Both A and B
5.

Failure to conduct adequate investigations of three media fill failures in the aseptic filling line represents what kind of Observation? What would the Investigator write?
- A.
  
  21 CFR Part 211.192
- B.
  
  21 CFR Part 211.113(b)
- C.
  
  Neither
6.

A "release of batches before the last successful media fill had been performed" represents what kind of observation?
- A.
  
  21 CFR Part 211.192
- B.
  
  21 CFR Part 211.113(b)
- C.
  
  Neither A nor B
7.

"The media fill program does not include all major contamination risk factors in your aseptic process, and, consequently, does not sufficiently demonstrate the state of the process control" represents what kind of observation?
- A.
  
  21 CFR Part 211.192
- B.
  
  21 CFR Part 211.113(b)
- C.
  
  Neither A nor B
8.

"You failed to perform adequate unidirectional airflow pattern studies (i.e., smoke studies for the aseptic filling line used for the production of (b) (4) injections" represents what kind of observation?
- A.
  
  21 CFR Part 211.192
- B.
  
  21 CFR Part 211.113(b)
- C.
  
  Neither A nor B