Free Access RAPS.RAC-US.v2023-04-24.q35 Practice Test (Page 2)

Question 1

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 analytical result of Company X API

B.Information deemed appropriate by the regulatory authority

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

Question 2

According to the ICH guideline on GMP for API, to which of the following is the MOST stringent requirement applied?

A.Production of Intermediate(s)

B.Physical processing and packaging

C.Introduction of the API starting material

D.Isolation and purification

Question 3

Which of the following is the MOST desirable timing and approach for a regulatory affairs professional who wants to provide feedback on proposed new regulations?

A.After the enactment of the regulation, through a product-specific meeting

B.After the enactment of the regulation, through the industry representative

C.Before the enactment of the regulation, through formal comments gathering process

D.Before the enactment of the regulation, through the industry representative

Question 4

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

A."It will satisfy hunger."

B."It will make you look younger."

C."It will whiten teeth."

D."It will prevent colds."

Question 5

A clinical study of a drug is completed to support a marketing approval application.
According to ICH, how long should a sponsor retain the clinical study essential documents?

A.For at least two years after the last approval of an application in an ICH region

B.Until the product has been discontinued from marketing in all ICH regions

C.Three years after the last clinical study site was supplied with investigational drugs

D.For a minimum of 10 years after completion of the clinical study

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