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Question:

Purified Water (PW) meets the quality requirements for sterile treatments, such as injectable products.
  1. True
  2. False






Q2. 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

Q3. What is 'a supervisor checking the temperature of food in a bain marie' an example of?

  1. Critical limit
  2. Hazard
  3. Critical limit
  4. Monitoring
Correct Answer

Q4. Where might we find information relating to a material’s hazards including Occupational Exposure Level and/or Hazard Category?

  1. On the front label of the material container or bag
  2. On the Material Safety Data Sheet (MSDS)
  3. On the delivery note from the supplier
  4. On the product sales brochure for the material
Correct Answer

Q5. 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

Q6. Sample containers should bear a label indicating the contents:

  1. The contents
  2. The batch number
  3. The date of sampling
  4. The containers from which samples have been drawn
  5. All of the above
Correct Answer

Q7. When using chlorine bleach to sanitize cutting boards, how much bleach should be added to each gallon of water?

  1. 1 cup
  2. 1 teaspoon
  3. 1 tablespoon
  4. 1 quart
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. CIP systems draw pharmaceutical-grade water into a break tank, where the water is heated or cooled as required. It is then pumped through pipework to sprayballs or product pathways to clean the equipment.

  1. True
  2. False
Correct Answer

Q10. What type of questions would you ask to confirm specific factual details:

  1. Open
  2. Closed
Correct Answer










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