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Question:

Which of the following statements is NOT true with regards to Water For Injection?
  1. A WFI is sterile
  2. WFI is used in the manufacture of parenteral (injectable) pharmaceuticals
  3. Distillation processes may be combined with pure steam production
  4. All of the above are true






Q2. When sanitizing dishclothes or cutting boards at home using chlorine bleach, how much bleach should be added, per quart of water?

  1. 1 teaspoon
  2. ½ cup
  3. ½ quart
  4. None of the above
Correct Answer

Q3. What type of questions would you ask to confirm specific factual details:

  1. Open
  2. Closed
Correct Answer

Q4. A potent Active Pharmaceutical Ingredient must be dispensed and transported from the Dispensary to the Manufacturing Room where it is then transferred into an enclosed batch mixing vessel. What would be the best container and transfer method for this material?

  1. An anti-static bag with zip-ties; the bag can be cut open over the open manway hatch of the mixing vessel
  2. A plastic bottle with a screw cap; the bottle can be tipped into the batch by opening the manway hatch of the mixing vessel
  3. A plastic bottle with a split butterfly valve; the top of the mixing vessel has the active SBV connection
Correct Answer

Q5. 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

Q6. 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

Q7. What’s the third step of HAACP

  1. Establishing Hazard Analysis
  2. Establishing Critical Control Limits
  3. Establishing Critical control points
  4. Verifying
Correct Answer

Q8. Any ‘close out’ of a corrective action must be completed by the auditor attending the client premises where the initial audit took place and the CAR was raised:

  1. True
  2. False
Correct Answer

Q9. Which of the following clauses are NOT part of BRC? i) Product safety & quality management ii) Continual improvement iii) Product inspection & testing iv) Operation

  1. i & iv
  2. ii & iv
  3. i, ii & iii
  4. All of the answers
Correct Answer

Q10. The organisation shall ensure that finished products are labelled according to all applicable food safety regulatory requirements in the country of manufacturing:

  1. True
  2. False
Correct Answer










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