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Question:

Quality Assurance testing guarantees that our products are sterile?
  1. True
  2. False






Q2. 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

Q3. Which one of the following questions should we know the answer(s) before designing a Purified Water system?

  1. Is Purified Water to be used in our product or is it an intermediate in making WFI?
  2. What grade of water have we registered as an excipient in our products and in which countries are our products used?
  3. How much Purified Water do we need (peak demand and per day)?
  4. All of the above
Correct Answer

Q4. 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

Q5. 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

Q6. Premises and equipment MUST BE:

  1. Located, designed, constructed, adapted and maintained to suit the operations to be carried out
  2. Permit effective cleaning and maintenance to prevent cross-contamination
  3. Layout and design must aim to minimise the risk of errors
  4. All of the above
Correct Answer

Q7. Stick to the ‘five second rule’ and you’ll be ok

  1. True
  2. False
Correct Answer

Q8. Bacteria multiply quickly in the Food Temperature Danger Zone. What is the temperature range for this zone?

  1. Between 30°F and 130°F.
  2. Between 45°F and 145°F.
  3. Between 40°F and 140°F.
  4. Between 40°F and 150°F.
  5. Between 50°F and 120°F.
Correct Answer

Q9. Visitors or untrained personnel should, preferably, not be taken into the production and quality control areas

  1. True
  2. False
Correct Answer

Q10. Which of the following is an acceptable technique for thawing a frozen turkey?

  1. In the refrigerator overnight.
  2. In the microwave.
  3. On the kitchen counter.
  4. Submerging it in cold water overnight.
  5. Leaving it in the garage overnight
Correct Answer










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