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Question:

There should be periodic management review, with the involvement of senior management, of the operation of the Pharmaceutical Quality System?
  1. True
  2. False






Q2. Which one of the following questions should we know the answer(s) before designing a Purified Water system?

  1. Is Purified Water to be used in our product or is it an intermediate in making WFI?
  2. What grade of water have we registered as an excipient in our products and in which countries are our products used?
  3. How much Purified Water do we need (peak demand and per day)?
  4. All of the above
Correct Answer

Q3. How cold should your refrigerator be to minimize the risk of food poisoning?

  1. 35°F or colder.
  2. 40°F or colder.
  3. 45°F or colder.
  4. 50°F or colder.
  5. 55°F or colder.
Correct Answer

Q4. A Contamination Control Strategy includes considerations such as facility design, gowning procedures as well as operating & cleaning procedures amongst others.

  1. False
  2. True
Correct Answer

Q5. The reprocessing of rejected products is common practice.

  1. True
  2. False
Correct Answer

Q6. Which of the following signs indicates that food has been contaminated by dangerous bacteria such as E. coli or salmonella?

  1. Bad smell
  2. Discoloration
  3. Off taste
  4. Slimy surface
  5. None of the above
Correct Answer

Q7. Highly active materials or products should be stored outside?

  1. True
  2. False
Correct Answer

Q8. Isolators can be used for a variety of applications including, dispensing of active ingredients, performing laboratory tests and to enclose filling lines?

  1. True
  2. False
Correct Answer

Q9. In order to properly wash your hands before or after handling food, exactly what is the minimum amount of time you should wash your hands under running water?

  1. 10 sec
  2. 20 sec
  3. 1 minute
  4. None of the above
Correct Answer

Q10. The temperature of a pot of beef stew is checked during holding. The stew has not met the critical limit and is thrown out according to house policy. Throwing out the stew is an example of which HACCP principle?

  1. Monitoring
  2. Verification
  3. Hazard analysis
  4. Corrective Action
Correct Answer










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