RAPS Regulatory Affairs Certification (RAC) US 認定 RAC-US 試験問題:

1. The requirements for document control are located in which of the following documents?

A) ISO 13485
B) WHO guidelines
C) ICH guidelines
D) IEC 60601

2. After submission to the regulatory authority, a substantial error was found in the application. In order to resolve this issue, what should be done FIRST?

A) Contact the legal department and ask them how to proceed.
B) Resubmit the entire package.
C) Inform upper management immediately.
D) Verify the procedure in the regulation for the corrections.

3. At the last internal audit, a regulatory affairs professional identified a need for a corrective action for the manufacturing process. Which of the following stakeholders should be notified FIRST?

A) Quality assurance
B) Clinical affairs
C) Quality improvement
D) Regulatory agency

4. The manufacturer of an API was changed from Company X to Company Y during the late stage of a new drug development. Despite differences in the manufacturing processes of the companies, both APIs meet the current specifications. Which is the MOST appropriate information to include in the final submission documents?

A) The process information and the comparative analytical result of APIs from both companies
B) The process information and analytical result of Company Y API
C) The process information and analytical result of Company X API
D) Information deemed appropriate by the regulatory authority

5. GHTF recommends that the medical device manufacturer define the scope of the clinical evaluation based on which of the following?

A) Risk analysis
B) Instructions for use
C) Essential principles
D) Product literature

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