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RAC Past Papers
RAC Past Papers
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Sample Questions
Question # 1:
A.
B.
C.
D.
Answer: A
Question # 2:
A drug product presents degradation during the manufacturing process. In
addition to the amount, what information should be provided FIRST in
order to use API overage?
A. Specification
B. Formulation
C. Property
D. Justification
Answer: D
Question # 3:
In the process of obtaining a product approval, a regulatory affairs
professional discovers that the product does not meet one of the specific
technical requirements of the regulation. However, competitors with
substantially similar products have claimed compliance with the
Question # 4:
Which of the following statements regarding export regulations for an
approved product is CORRECT?
A. The product must not be in accord with the specifications of the foreign
purchaser.
B. The product must not be in conflict with the laws of the country to
which it is intended for export.
C. The product must not be labeled on the outside of the shipping package
that it is intended for export.
D. The product must not be sold or offered for sale in domestic commerce.
Answer: B
Question # 5:
The intermediate manufacturing process was changed during development
of a pharmaceutical. The change may impact the API specification. Which
functional area is responsible for the final approval of the change?
A. Production
B. Analytical
C. Quality
D. Regulatory
Answer: C, D
Question # 6:
Under which of the following circumstances would a regulatory authority
require a more detailed premarket submission, a more rigorous audit,
and/or the provision of more performance evaluation data than would
normally apply to an IVD device of that risk class?
A. The device is an updated version of a compliant device from the same
manufacturer and contains no substantive change.
B. Internationally recognized standards are available to cover the main
aspects of the device and have been used by the manufacturer.
C. The manufacturer's experience level with the type of IVD medical device
is limited.
D. The device incorporates well-established technology that is already
present in the market.
Answer: C
Question # 7:
According to WHO, what are the temperature and humidity conditions for a
Zone IVb long term stability study?
A.
B.
C.
D.
Answer: D
Question # 8:
During routine surveillance, a regulatory authority sent a company the
following communication: "Hepatotoxicity and suicidal behavior were
identified as potential safety issues for the company's product. The
regulatory authority is evaluating these issues to determine the need for
any regulatory action." Which action would be the most appropriate FIRST
step for the company to take?
A. Contact the regulatory authority to argue that its conclusions are wrong.
B. Contact the regulatory authority to discuss its findings.
C. Repeat the Hepatotoxicity tests and send the results to the regulatory
authority.
D. Wait for the regulatory authority's final publication on its findings.
Answer: B
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