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Question:

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






Q2. Highly active materials or products should be stored outside?

  1. True
  2. False
Correct Answer

Q3. Plastic chopping boards are more hygienic than wooden ones

  1. True
  2. False
Correct Answer

Q4. When it comes to food safety, which of the following is the best material for a cutting board?

  1. Wood
  2. Plastic or acrylic
  3. Glass
  4. Velcro
Correct Answer

Q5. Which sterilization technique is suitable for temperature sensitive products?

  1. Pure steam sterilization
  2. Sterile filtration
  3. Both A & B
Correct Answer

Q6. What type of questions would you ask to gain more information:

  1. Open
  2. Closed
Correct Answer

Q7. 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

Q8. How cold should your refrigerator be to minimize the risk of food poisoning?

  1. 35°F or colder.
  2. 40°F or colder.
  3. 45°F or colder.
  4. 50°F or colder.
  5. 55°F or colder.
Correct Answer

Q9. 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

Q10. 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










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