最新的 RAC Regulatory Affairs Certification RAC-US 免費考試真題:

1. Which of the following claims would classify an apple as a drug?

A) "It will make you look younger."
B) "It will whiten teeth."
C) "It will satisfy hunger."
D) "It will prevent colds."

2. A process is ultimately validated to ensure which of the following?

A) The process meets the regulatory requirements.
B) The process consistently meets the desired Quantity standards
C) The process meets the quality system requirements.
D) The process consistently produces the desired results.

3. 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) Repeat the Hepatotoxicity tests and send the results to the regulatory authority.
C) Contact the regulatory authority to discuss its findings.
D) Wait for the regulatory authority's final publication on its findings.

4. A regulatory authority announces an inspection of a regulatory affairs professional's facility during a holiday season when most of the staff Is not available. What is the MOST practical approach to this dilemma?

A) Inform the authority that the time is not suitable and request a new time
B) Insist that key personnel be available for the inspection.
C) Arrange for an inspection without all intended personnel.
D) Negotiate with colleagues and the authority to find a better time.

5. Which of the following criteria is MOST appropriate to define the animal species needed for the pre-clinical toxicity testing of a biotechnology product?

A) Biological activity with species and/or tissue specificity
B) Proposed dose and volume of administration
C) Immunochemical and functional tests
D) Proposed product route and frequency of administration

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