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Question:

Which of the following statements is true?
  1. A pharmaceutical water system can be used for production use as soon as it is constructed
  2. A pharmaceutical water system can be used for production use as soon as all the safety devices have been tested
  3. A pharmaceutical water system can be used for production use once Operational Qualification has been successfully performed and approved by the authorised QA representative
  4. A pharmaceutical water system can be used for production use only after the Performance Qualification phase (12 months) has been successfully approved by the authorised QA representative






Q2. Which sterilization technique is suitable for temperature sensitive products?

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

Q3. Which are below the non-conformities level given for BRC certification? i) Critical ii) Major iii) Minor iv) Opportunity for improvement

  1. ii & iii
  2. i, ii & iii
  3. i, ii & iv
  4. All of the answers
Correct Answer

Q4. 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

Q5. A circumstance in which direct food safety is impacted without appropriate action by the organisation is observed during the audit and/or, when legality and/or certification integrity are at stake would be classified as a:

  1. Critical NC
  2. Major NC
  3. Not nonconformity
  4. Minor NC
Correct Answer

Q6. Which is the minimum temperature at which hot foods on a buffet should be maintained?

  1. 212°F
  2. 180°F
  3. 140°F
  4. None of the above
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. What does the acronym HVAC stand for?

  1. Heating, ventilation and chilling
  2. heating, ventilation and automatic cooling
  3. Heating, ventilation and air conditioning
  4. For seven years
Correct Answer

Q9. At what temperature should your refrigerator be maintained?

  1. 60°F
  2. 45°F
  3. 40°F
  4. None of the above
Correct Answer

Q10. Monitoring water systems requires evaluation and responses to:

  1. Trend and seasonal variations
  2. Water quality incidents or events which trigger alarms
  3. Both A & B
Correct Answer










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