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Question:

An audit by the organisation of its own management system and procedures is also known as a:
  1. First party audit
  2. Second party audit
  3. Third party audit
  4. Surveillance audit






Q2. A Contamination Control Strategy includes considerations such as facility design, gowning procedures as well as operating & cleaning procedures amongst others.

  1. False
  2. True
Correct Answer

Q3. HACCP can be applied to industries other than food.

  1. True
  2. False
Correct Answer

Q4. 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

Q5. 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

Q6. When using chlorine bleach to sanitize cutting boards, how much bleach should be added to each gallon of water?

  1. 1 cup
  2. 1 teaspoon
  3. 1 tablespoon
  4. 1 quart
Correct Answer

Q7. Plastic chopping boards are more hygienic than wooden ones

  1. True
  2. False
Correct Answer

Q8. 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

Q9. A potent Active Pharmaceutical Ingredient must be dispensed and transported from the Dispensary to the Manufacturing Room where it is then transferred into an enclosed batch mixing vessel. What would be the best container and transfer method for this material?

  1. An anti-static bag with zip-ties; the bag can be cut open over the open manway hatch of the mixing vessel
  2. A plastic bottle with a screw cap; the bottle can be tipped into the batch by opening the manway hatch of the mixing vessel
  3. A plastic bottle with a split butterfly valve; the top of the mixing vessel has the active SBV connection
Correct Answer

Q10. You don’t need to wash raw chicken before you cook it

  1. True
  2. False
Correct Answer








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