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RAPS Regulatory Affairs Certification (RAC) US Sample Questions (Q22-Q27):

NEW QUESTION # 22
A company is preparing the submission package for a drug to be registered in international markets. When preparing the legal documentation, which document MUST comply with the
WHO recommendations?

A. Certificate of Analysis for the finished product
B. Certificate of Free Sale
C. Certificate of GMP
D. Certificate of Pharmaceutical Product

Answer: D

NEW QUESTION # 23
In which section of the ICH Common Technical Document will the overview of clinical data appear?

A. Module 2
B. Module 4
C. Module 1
D. Module 3

Answer: A

NEW QUESTION # 24
Which of the following BEST describes the process of post-marketing surveillance for healthcare products?

A. Systematic procedure to review experiences with the products in use
B. Vigilance procedure to ensure the full traceability of the products
C. Systematic procedure to review published scientific journals
D. Vigilance procedure to notify the regulatory authorities about serious incidents

Answer: B

NEW QUESTION # 25
An inspection of a manufacturing site determines that a number of manufacturing changes have been implemented without obtaining the necessary regulatory clearance. Which of the following actions should the regulatory affairs professional complete FIRST?

A. Assess the impact of the changes.
B. Stop product manufacturing.
C. Review the stability data for the changes.
D. Establish validation procedures.

Answer: B

NEW QUESTION # 26
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. Information deemed appropriate by the regulatory authority
B. The process information and analytical result of Company X API
C. The process information and analytical result of Company Y API
D. The process information and the comparative analytical result of APIs from both companies

Answer: D

NEW QUESTION # 27
......

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