Free Access RAPS.RAC-GS.v2022-03-28.q35 Practice Test (Page 2)

Question 1

A regulatory affairs professional has submitted a package for regulatory review. According to the
regulation, the regulatory authority will need to respond within 90 days of submission. If there is no
response after the deadline, what is the BEST approach?

A.Contact the local political representative and ask for intervention with the regulatory authority to obtain
a decision regarding the submission.

B.Contact the regulatory authority, ask for clarification about the delay, and provide answers to any
outstanding questions.

C.Contact the company legal representative in order to begin legal proceedings to enforce the regulatory
authority's response time.

D.Contact the regulatory authority, ask for clarification about the delay, and demand a decision be made
regarding the submission.

Question 2

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

A.The process consistently meets the desired Quantity standards

B.The process meets the regulatory requirements.

C.The process consistently produces the desired results.

D.The process meets the quality system requirements.

Question 3

Which of the following BEST describes the content of the "Physical, Chemical, and Pharmaceutical
Properties and Formulation" section of an IB?

A.A detailed summary of the physical and chemical properties of the drug product with a signed expert
statement addressing the suitability and stability of the formulation for its intended use

B.A description and flow chart illustrating the synthetic route for the active ingredient and the preparation
method of the finished product

C.A review of available data to support the determination of the chemical structure and physical attributes
of the drug substance plus batch analysis and stability data for the finished formulation

D.A brief summary of relevant physical, chemical, and pharmaceutical properties: instructions for storage
and handling of the dosage form: and a description of the formulation

Question 4

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

A.Introduction of the API starting material

B.Isolation and purification

C.Physical processing and packaging

D.Production of Intermediate(s)

Question 5

At a recent scientific meeting, Company Y had two booths:
. At one booth, Company Y provided brochures on a completed Phase II study.
. In an adjacent booth, Company Y's sales professionals were promoting one of Company Y's marketed
products.
A regulatory affairs-professional at Company X sends a letter to a counterpart at Company Y requesting
that Company Y stop this practice in the future and demanding a formal response to the letter. How
should the regulatory affairs professional at Company Y BEST respond?

A.Inform the legal department of the letter and discuss how to respond.

B.Acknowledge receipt of the letter in a written response but do nothing further.

C.Inform the local regulatory authority of the letter and discuss how to respond.

D.Inform Company X that it has no right to send such a letter and do nothing further.

Other Version: 37RAPS.Braindumpspass.RAC-GS.v2021-11-08.by.merle.33q.pdf

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