Dec-2021 RAPS RAC-GS Actual Questions and 100% Cover Real Exam Questions
RAC-GS Free Exam Questions & Answers PDF Updated on Dec-2021
NEW QUESTION 46
What is the BEST approach to ensure that raw materials, services, and sub-contractors at the level of the
vendors comply with GMP requirements?
- A. Document and perform audits.
- B. Request documentation from the sub-contractor.
- C. Request an inspection from a regulatory authority.
- D. Ask the vendor to take responsibility.
Answer: A
NEW QUESTION 47
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 48
During a routine review of promotional materials for a product, a regulatory affairs professional discovers
an off-label indication. Which of the following would be the FIRST follow-up action for the regulatory
affairs professional to take?
- A. Request that doctors stop using the product for the off-label indication.
- B. Communicate with the sales department to stop using the promotional materials.
- C. Allow doctors to use the product for the off-label indication.
- D. Contact the marketing department to recall the product.
Answer: B
NEW QUESTION 49
The intermediate manufacturing process was changed during development of a pharmaceutical. The
change may impact the API specification. Which functional area is responsible for the final approval of the
change?
- A. Production
- B. Quality
- C. Analytical
- D. Regulatory
Answer: B
NEW QUESTION 50
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 51
Company X is planning to acquire the rights for a product marketed by Company Y. As part of due
diligence, what is the MOST important information the Company X regulatory affairs professional should
ask senior management to request from Company Y?
- A. Intellectual properly
- B. Marketing materials
- C. Clinical trial data
- D. Safety issues
Answer: D
NEW QUESTION 52
In the process of obtaining a product approval, a regulatory affairs professional discovers that the product
does not meet one of the specific technical requirements of the regulation. However, competitors with
substantially similar products have claimed compliance with the requirement and received approval.
Which action should the regulatory affairs professional take FIRST?
- A. Inform the internal departments to redesign the product to comply with this requirement.
- B. Discuss with the regulatory apriority and attempt to reach an acceptable solution.
- C. Notify senior management that the product cannot be registered.
- D. Inform the regulatory authority that such a requirement is not applicable to the product.
Answer: B
NEW QUESTION 53
Following the introduction of a new regulation, an evaluation of the company's products by the regulatory
affairs professional indicates that 60 percent do not comply with the regulation.
What should the regulatory affairs professional do FIRST to meet the new requirement?
- A. Request a permanent waiver from the new regulation.
- B. Contact the trade association for advice.
- C. Prepare documents for the files.
- D. Communicate with the relevant internal departments.
Answer: D
NEW QUESTION 54
As part of the regulatory strategy for companies intending to manufacture a psychotropic product, which
of the following approvals should be received FIRST?
- A. Import license
- B. Export license
- C. Site license
- D. Product license
Answer: C
NEW QUESTION 55
After numerous failed attempts to decrease an identified risk in a medical device to an acceptable level,
the medical device continues to have unacceptable risks. However, the development team wants to
continue development. Which is the BEST recommendation to make in this situation?
- A. Discontinue the project.
- B. Redesign the device.
- C. Add a warning in the IFU.
- D. Perform another risk-benefit analysis.
Answer: B
NEW QUESTION 56
The requirements for document control are located in which of the following documents?
- A. WHO guidelines
- B. ISO 13485
- C. ICH guidelines
- D. IEC 60601
Answer: B
NEW QUESTION 57
The safety database for an anti-hypertensive drug consists of the following:
. 461 patients exposed for three months
. 343 patients exposed for six months
. 112 patients exposed for nine months
. 74 patients exposed for 12 months
Overall exposure is 2.000 patients. Which long-term ICH data requirement has NOT been met?
- A. 200 patients for nine months
- B. 3.000 total patient exposures
- C. 100 patients for 12 months
- D. 500 patients for three months
Answer: C
NEW QUESTION 58
You discover that your company's top selling product in the last two years has been used off-label. The
off-label use is estimated to be about 70%, and it has been consistent since the product was first released
to the market. Which of the following is MOST appropriate?
- A. No action is required since it is an off-label use.
- B. File a report to regulatory authorities and advise the marketing department to prevent future off-label
use. - C. Advise the senior management to send a "Dear Dr." letter.
- D. Discuss with regulatory authorities to investigate how to have the off-label indication approved.
Answer: D
NEW QUESTION 59
Which of the following statements regarding the off-label use of drugs is CORRECT?
- A. Sponsors are allowed to distribute publications about unapproved uses of approved drugs and devices
as long as the marketing application is under review by the regulatory authority. - B. Although the regulatory authority reviews and approves drugs for specific indications, the approval
does not limit the use of those drugs in clinical practice. - C. The peer-reviewed literature can ensure high-quality off-label promotion of medications, thereby
increasing access to much needed drugs and devices. - D. The regulatory authority does not restrict physician prescribing for off-label indications or regulate the
manufacturer's promotion for such use.
Answer: B
NEW QUESTION 60
A company is developing a novel drug to combat AIDS. The preliminary results are very promising and
include instances of complete remission. The company has been granted patents in multiple countries for
the drug. The regulatory affairs professional is asked to prepare a brief report concerning potential
problems for marketing of the product worldwide. Which of the following is the MOST important
consideration to discuss?
- A. The time frame in which the patent will expire
- B. International import and export regulations
- C. The stability of the drug in all zone conditions
- D. Doha Declaration in the TRIPS Agreement
Answer: C
NEW QUESTION 61
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 62
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