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Question:

Which of the listed document types ARE required GMP documentation?
  1. Site Master File and Specifications
  2. Manufacturing Formulae, Processing, Packaging and Testing Instructions
  3. Certificate of Analysis, Procedures and Protocols
  4. Technical Agreements, Records and Reports
  5. All of the above






Q2. Which of the following bacteria are responsible for causing the greatest number of foodborne illnesses?

  1. Salmonella
  2. Campylobacter
  3. E. coli
  4. None of the above
Correct Answer

Q3. How many clauses does BRC have?

  1. 6
  2. 7
  3. 8
  4. 9
Correct Answer

Q4. The organisation shall ensure that finished products are labelled according to all applicable food safety regulatory requirements in the country of manufacturing:

  1. True
  2. False
Correct Answer

Q5. Which of the listed document types ARE required GMP documentation?

  1. Site Master File and Specifications
  2. Manufacturing Formulae, Processing, Packaging and Testing Instructions
  3. Certificate of Analysis, Procedures and Protocols
  4. Technical Agreements, Records and Reports
  5. All of the above
Correct Answer

Q6. Purified Water (PW) meets the quality requirements for sterile treatments, such as injectable products.

  1. True
  2. False
Correct Answer

Q7. 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

Q8. What type of questions would you ask to gain more information:

  1. Open
  2. Closed
Correct Answer

Q9. Rapid cooling is an example of...

  1. a corrective action
  2. a hazard
  3. a critical limit
  4. a control measure
  5. Incorrect monitoring
Correct Answer

Q10. If food looks ok and smells ok it’s safe to eat

  1. True
  2. False
Correct Answer










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