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Question:

In GMP guidelines, what is the recommended differential pressure between areas of different classification?
  1. 1 to 2 Pascals
  2. 10 to 15 Pascals
  3. 100 to 500 Pascals






Q2. What does the acronym HVAC stand for?

  1. Heating, ventilation and chilling
  2. heating, ventilation and automatic cooling
  3. Heating, ventilation and air conditioning
  4. For seven years
Correct Answer

Q3. Why are airlocks employed between areas of different classifications?

  1. To maintain the air pressure cascade between areas of different classification
  2. To provide security access control (SAC)
  3. To provide dedicated areas for storing personal belongings of personnel
  4. To provide a convenient place to store materials
Correct Answer

Q4. Pharmaceutical Water should continuously circulate with a turbulent flow rate to help prevent the formation of biofilm.

  1. True
  2. False
Correct Answer

Q5. On pharmaceutical water distribution loops, an air break should exist between the Point-Of-Use valves and the downstream manufacturing processes?

  1. True
  2. False
Correct Answer

Q6. 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

Q7. Quality Control DOES NOT require that:

  1. Test methods are validated
  2. No batch of product is released for sale or supply prior to certification by an Authorised Person
  3. Staff are regularly and sufficiently supplied with caffeine
  4. Sufficient reference samples of starting materials and products are retained to permit future examination
Correct Answer

Q8. 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

Q9. At what temperature should your refrigerator be maintained?

  1. 60°F
  2. 45°F
  3. 40°F
  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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