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Question:

Which sterilization technique is suitable for temperature sensitive products?
  1. Pure steam sterilization
  2. Sterile filtration
  3. Both A & B






Q2. What type of questions would you ask to gain more information:

  1. Open
  2. Closed
Correct Answer

Q3. Which of the following bacteria are responsible for causing the greatest number of food borne illnesses?

  1. E. coli
  2. Salmonella
  3. Botulism
  4. Listeria
  5. Indigestion
Correct Answer

Q4. It should be clearly defined which record is related to each manufacturing activity

  1. True
  2. False
Correct Answer

Q5. 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

Q6. The reprocessing of rejected products is common practice.

  1. True
  2. False
Correct Answer

Q7. 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

Q8. What is the primary purpose of Product Containment?

  1. To ensure materials are clearly labelled
  2. To minimize the extent of cleaning after the process operation
  3. To protect operators/personnel from exposure to potent of toxic materials
  4. To prevent spillage
Correct Answer

Q9. 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

Q10. The process of determining whether the corrective action requested has been implemented is called the follow-up. This can be done by reviewing documentation submitted by the client or by visiting the client premises:

  1. True
  2. False
Correct Answer










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