Updated Free RAPS RAC-GS Test Engine Questions with 100 Q&As
The Best RAC Regulatory Affairs Certification RAC-GS Professional Exam Questions
NEW QUESTION 28
A materials supplier informs a company that it intends to stop supplying a material critical to the
manufacture of the company's products. What action should the company take FIRST?
- A. Complete a gap analysis to identify options.
- B. Review the company's existing Quality Management System
- C. Reformulate the products with a replacement material.
- D. Qualify another supplier and execute a supplier agreement.
Answer: D
NEW QUESTION 29
SOPs for preventive and corrective actions MUST include the procedure to eliminate which of the
following?
- A. Causes of non-conformities
- B. Inadequate training
- C. Adverse environmental impacts
- D. Late and/or incorrect deliverables
Answer: A
NEW QUESTION 30
A company is developing a new line of products in an area that is new to the company. What is the BEST
approach?
- A. Summarize regulatory documents and history and provide the information to the management team.
- B. Ask the trade association representative to provide an overview of the new product area to the
marketing team. - C. Obtain competitor research and provide the information to the management team.
- D. Obtain regulatory documents and history and provide the information to R&D.
Answer: A
NEW QUESTION 31
Which of the following claims would classify an apple as a drug?
- A. "It will prevent colds."
- B. "It will satisfy hunger."
- C. "It will make you look younger."
- D. "It will whiten teeth."
Answer: A
NEW QUESTION 32
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. Product literature
- D. Essential principles
Answer: A
NEW QUESTION 33
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 regulatory authority, ask for clarification about the delay, and demand a decision be made
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 local political representative and ask for intervention with the regulatory authority to obtain
a decision regarding the submission.
Answer: B
NEW QUESTION 34
According to the GHTF, which of the following is NOT an exemption rule when evaluating the decision to
report an adverse event?
- A. Adverse event caused by patient conditions
- B. Deficiency of a device found by the user prior to patient use
- C. Malfunction occurring before the end of service life of the medical device
- D. Malfunction protection operated correctly
Answer: A
NEW QUESTION 35
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 local regulatory authority of the letter and discuss how to respond.
- B. Inform the legal department of the letter and discuss how to respond.
- C. Acknowledge receipt of the letter in a written response but do nothing further.
- D. Inform Company X that it has no right to send such a letter and do nothing further.
Answer: B
NEW QUESTION 36
When applying for marketing approval of a drug for a rare disease, which requirement can be waived?
- A. Pre-clinical studies
- B. Phase I clinical trials
- C. Phase I and II clinical trials
- D. Phase III clinical trials
Answer: D
NEW QUESTION 37
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. Three years after the last clinical study site was supplied with investigational drugs
- C. Until the product has been discontinued from marketing in all ICH regions
- D. For a minimum of 10 years after completion of the clinical study
Answer: A
NEW QUESTION 38
According to WHO, what are the temperature and humidity conditions for a Zone IVb long-term stability
study?
- A. 25: C and 60% RH
- B. 30c C and 65% RH
- C. 30 C and 35% RH
- D. 30: C and 75% RH
Answer: D
NEW QUESTION 39
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. Repeat the Hepatotoxicity tests and send the results to the regulatory authority.
- B. Contact the regulatory authority to discuss its findings.
- C. Wait for the regulatory authority's final publication on its findings.
- D. Contact the regulatory authority to argue that its conclusions are wrong.
Answer: B
NEW QUESTION 40
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. Isolation and purification
- C. Physical processing and packaging
- D. Introduction of the API starting material
Answer: C
NEW QUESTION 41
Which of the following is MOST appropriate for the purpose of lot release of biologics?
- A. Quality verification
- B. Inventory control
- C. Efficacy confirmation
- D. Safety assurance
Answer: A
NEW QUESTION 42
In order to develop a global drug product, what is the MOST important environmental characteristic to
consider in the country of intended use?
- A. Product stability
- B. Product requirements
- C. Product formulation
- D. Product registration
Answer: A
NEW QUESTION 43
What is the LAST stage in the development of a quality risk management process for a medical device?
- A. Risk acceptance
- B. Risk reduction
- C. Risk evaluation
- D. Risk analysis
Answer: A
NEW QUESTION 44
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