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Question:

A Contamination Control Strategy includes considerations such as facility design, gowning procedures as well as operating & cleaning procedures amongst others.
  1. False
  2. True






Q2. Minor NC should be closed out and the objective evidence should be submitted to the CB:

  1. within 14 days
  2. within 28 days
  3. within 90 days
  4. Incorrect in the next audit visit
Correct Answer

Q3. Which of the following options is a form of Secondary Containment?

  1. Glovebox isolator
  2. Split Butterfly Valve
  3. Downflow Booth
  4. Negatively-pressurised room
Correct Answer

Q4. 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

Q5. The process of determining whether the corrective action requested has been implemented is called the follow-up. This can be done by reviewing documentation submitted by the client or by visiting the client premises:

  1. True
  2. False
Correct Answer

Q6. Which of the following statements is true?

  1. A pharmaceutical water system can be used for production use as soon as it is constructed
  2. A pharmaceutical water system can be used for production use as soon as all the safety devices have been tested
  3. A pharmaceutical water system can be used for production use once Operational Qualification has been successfully performed and approved by the authorised QA representative
  4. A pharmaceutical water system can be used for production use only after the Performance Qualification phase (12 months) has been successfully approved by the authorised QA representative
Correct Answer

Q7. 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

Q8. Practices and procedures intended to prevent food borne illnesses

  1. Staff Health control
  2. Food safety management systems
  3. Consumer advisories
  4. Active managerial control
Correct Answer

Q9. What type of questions would you ask to confirm specific factual details:

  1. Open
  2. Closed
Correct Answer

Q10. Plastic chopping boards are more hygienic than wooden ones

  1. True
  2. False
Correct Answer










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