Q. Corrective action is

  1. Monitoring indicates a deviation from a critical limit
  2. Monitoring indicates a deviation in process of RM
  3. Monitoring indicates a shift in production quality
  4. Monitoring indicates a detect in production

Answer: a)

Corrective action is to monitoring indicates a deviation from a critical limit.

Q. CAPA applied in

  • GHP
  • ISO 9001
  • GMP
  • None of the above

Answer: b)

CAPA within ISO 9001 and within the regulation FDA 21 CFR 820 and outlines how and what data sources serve users well in preventive action analysis.

Q. ISO 9001: 2008 has how many clauses

  • 5
  • 6
  • 9
  • 8

Answer: d)

ISO 9001:2008 has eight clauses (Clauses 4-8 are requirements) whereas, ISO 9001:2015 has ten (Clauses 4-10 are requirements).

Q. Which of these is a safety gear

  • Gloves
  • Apron
  • Safety shoes
  • All of the above

Answer: d)

Protective equipment includes gloves, finger guards and arm coverings.

Q. Which of these is a class I recall

  • Hazard that causes serious health consequences or death effect
  • Food will not or is not likely to cause adverse health consequences
  • Probability of adverse health consequences from eating the food
  • All of the above

Answer: a)

Class I recall: a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

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