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Question:

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






Q2. 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

Q3. Which of the following groups of people have a higher than normal chance of contracting a case of food poisoning?

  1. Very young children
  2. Pregnant women
  3. The elderly
  4. Persons with compromised immune systems
  5. All of the above
Correct Answer

Q4. What is the benefit of having BRC certification? i) Stabilization of customer confidence ii) Higher product security iii) Higher product liability risks iv) Timely notice of consumer risks concerning hygiene and security consumer goods

  1. i & ii
  2. i, ii & iii
  3. ii & iv
  4. i, ii & iv
Correct Answer

Q5. Who should prepare the audit plan for on-site activities:

  1. Audit Team Leader
  2. Any of Audit Team Members
  3. Auditee
  4. Top management
Correct Answer

Q6. The reprocessing of rejected products is common practice.

  1. True
  2. False
Correct Answer

Q7. 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

Q8. Pharmaceutical HVAC systems differ from commercial or industrial systems because they:

  1. Pharmaceutical HVAC systems differ from commercial or industrial systems because they:
  2. Require more rigorous testing and qualification
  3. Have regulatory requirements for ongoing maintenance and testing
  4. All of the above
Correct Answer

Q9. Rejecting a delivery of over temperature raw foods, informing supplier and investigating cause, is an example of...

  1. hazards
  2. monitoring
  3. corrective action
  4. critical limit
  5. control measure
Correct Answer

Q10. According to BRC, in which clause specify that any cut or grazes skin need to be covered by using contrasting colour plaster.

  1. 3.6.1
  2. 3.11.3
  3. 7.3.2
  4. 2.1.3
Correct Answer








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