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Question:

Which is NOT one of the HACCP principles
  1. Check the system and verify that it works
  2. Identify likely hazards
  3. Establish Critical control points
  4. Develops procedures to educate the regulators about the HACCP principles






Q2. The reprocessing of rejected products is common practice.

  1. True
  2. False
Correct Answer

Q3. The supply chain and traceability records for each active substance (including active substance starting materials) should be available.

  1. True
  2. False
Correct Answer

Q4. Purified Water (PW) meets the quality requirements for sterile treatments, such as injectable products.

  1. True
  2. False
Correct Answer

Q5. Which BRC clause specify organization to have policy and management review?

  1. Production inspection & testing
  2. Process control
  3. Personnel
  4. Senior management commitment
Correct Answer

Q6. 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
Correct Answer

Q7. 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

Q8. Sample containers should bear a label indicating the contents:

  1. The contents
  2. The batch number
  3. The date of sampling
  4. The containers from which samples have been drawn
  5. All of the above
Correct Answer

Q9. What is BRC stands for?

  1. Baghdad Roasted Chicken
  2. British Retail Consortium
  3. British Reinforcement Company
  4. Biomedical Research Centre
Correct Answer

Q10. Which sterilization technique is suitable for temperature sensitive products?

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










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