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Question:

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






Q2. ‘Use by’ dates are there to make you buy more

  1. True
  2. False
Correct Answer

Q3. Audit evidence may be obtained from people, processes, equipment, tools, materials, documentation and by observation and, is defined as records, statements of facts or other information which are relevant to the audit criteria and verifiable. (ISO 19011:2018):

  1. True
  2. False
Correct Answer

Q4. Sufficient trained personnel and resources should be made available for the review of complaints and quality defects?

  1. True
  2. False
Correct Answer

Q5. 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

Q6. 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

Q7. When conducting a hazard analysis, which of the following is included?

  1. identifying corrective actions
  2. identifying critical limits
  3. establishing records
  4. identifying control measures
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. Mould is the number one risk factor for contamination of a clean room due to temperature and moisture factors.

  1. True
  2. False
Correct Answer

Q10. 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










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