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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

2. Which of the following statements are true?

  1. Aseptic techniques rely upon exposing the product to the minimum possible risk of contamination
  2. Aseptic techniques require extensive training and validation
  3. We aim to keep human interaction to a minimum using physical barriers and automation
  4. Process equipment and primary contact containers must be sterilised and maintained under Aseptic conditions
  5. All of the above
Correct Answer

3. Monitoring water systems requires evaluation and responses to:

  1. Trend and seasonal variations
  2. Water quality incidents or events which trigger alarms
  3. Both A & B
Correct Answer

4. Who is responsible for ensuring that processes are in place to assure control of outsourced activities?

  1. Contract giver
  2. Contract acceptor
  3. Both the contract giver and the contract acceptor
Correct Answer

5. A new restaurant decides to develop a HACCP Plan- the First Step is

  1. Monitor
  2. Verify
  3. Hire a consulting company
  4. Conduct a Hazard Analysis
Correct Answer

6. What is the goal of HACCP?

  1. Keep the establishment pest free
  2. To raise money in fees for the federal gov't
  3. To establish awareness of the safety rules for employees
  4. Identify and control possible hazards throughout the flow of food
Correct Answer

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

  1. True
  2. False
Correct Answer

8. What is the minimum temperature to which ground beef should be cooked to make sure it is free from harmful bacteria?

  1. 220°F
  2. 140°F
  3. 165°F
  4. 160°F
  5. 350°F
Correct Answer

9. A critical limit must be...

  1. Measurable in real time
  2. Stated in legislation
  3. Incorrect A range of values
  4. Higher than the target level
Correct Answer

10. A circumstance in which direct food safety is impacted without appropriate action by the organisation is observed during the audit and/or, when legality and/or certification integrity are at stake would be classified as a:

  1. Critical NC
  2. Major NC
  3. Not nonconformity
  4. Minor NC
Correct Answer

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