Latest [Dec 26, 2021] RAC-GS Exam Questions – Valid RAC-GS Dumps Pdf
RAC-GS Practice Test Questions Answers Updated 100 Questions
NEW QUESTION 56
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 Free Sale
- B. Certificate of Pharmaceutical Product
- C. Certificate of GMP
- D. Certificate of Analysis for the finished product
Answer: B
NEW QUESTION 57
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. Doha Declaration in the TRIPS Agreement
- B. The stability of the drug in all zone conditions
- C. International import and export regulations
- D. The time frame in which the patent will expire
Answer: B
NEW QUESTION 58
Which of the following changes to a drug product is MOST likely to be implemented without prior
regulatory authority approval?
- A. Introducing a new analytical method
- B. Deleting an ingredient of the drug product
- C. Strengthening a precaution to the product labeling
- D. Deleting a drug substance
Answer: C
NEW QUESTION 59
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 company legal representative in order to begin legal proceedings to enforce the regulatory
authority's response time. - C. Contact the local political representative and ask for intervention with the regulatory authority to obtain
a decision regarding the submission. - D. Contact the regulatory authority, ask for clarification about the delay, and provide answers to any
outstanding questions.
Answer: D
NEW QUESTION 60
According to ICH, what is the MAXIMUM amount of time in calendar days that an organization has from
the initial receipt of information to report serious and unexpected ADR of a marketed product to regulatory
authorities?
- A. 0
- B. 1
- C. 2
- D. 3
Answer: A
NEW QUESTION 61
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. Request documentation from the sub-contractor.
- B. Request an inspection from a regulatory authority.
- C. Ask the vendor to take responsibility.
- D. Document and perform audits.
Answer: D
NEW QUESTION 62
Company X acquires Company Y. Both companies produce pharmaceuticals distributed globally. A
regulatory authority requires that all labeling for Company Y's products be converted to Company X within
three months. The regulatory affairs professional at Company X concludes that it is not feasible to meet
this request within the time frame.
Which is the FIRST step that the regulatory affairs professional at Company X should take to address the
situation?
- A. Submit as many labeling conversion applications as possible within the time frame and request an
extension for the remaining ones. - B. Develop a plan of action with tasks, timelines, and responsibilities and request an extension period
from the regulatory authority. - C. Request additional resources from senior management in order to complete the labeling conversion
within the time frame given by the regulatory authority. - D. Convene an urgent meeting with internal stakeholders to inform them of the regulatory authority
requirement and assign responsibilities.
Answer: B
NEW QUESTION 63
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 registration
- B. Product stability
- C. Product formulation
- D. Product requirements
Answer: B
NEW QUESTION 64
Which of the following BEST describes the process of post-marketing surveillance for healthcare
products?
- A. Vigilance procedure to notify the regulatory authorities about serious incidents
- B. Systematic procedure to review experiences with the products in use
- C. Vigilance procedure to ensure the full traceability of the products
- D. Systematic procedure to review published scientific journals
Answer: C
NEW QUESTION 65
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. Before the enactment of the regulation, through formal comments gathering process
- B. After the enactment of the regulation, through a product-specific meeting
- C. Before the enactment of the regulation, through the industry representative
- D. After the enactment of the regulation, through the industry representative
Answer: A
NEW QUESTION 66
A regulatory affairs professional is asked to review and update regulatory affairs SOPs. Which aspect of
the SOP Is MOST important to consider?
- A. Scope and level of detail
- B. Expiration date
- C. Revision history
- D. Relevance to regulations
Answer: D
NEW QUESTION 67
Why is it necessary to run supplemental safety pharmacology studies?
- A. To provide adverse reaction reports and the results of the statistical data to the regulatory authority
- B. To evaluate potential adverse pharmacodynamics effects not addressed by the core battery
- C. To comply with regulatory authority requirements related to clinical studies
- D. To substitute the utilization of GLP
Answer: B
NEW QUESTION 68
During the review of a design dossier, the reviewer asks why the company has only carried out a
top-down risk approach. The reviewer is referring to which of the following?
- A. Failure mode and effect analysis
- B. ISO 14971 risk analysis
- C. Hazard and operability study
- D. Fault tree analysis
Answer: B
NEW QUESTION 69
During new drug development, a new impurity in the drug substance is detected at a level of 0.12%. The
intended maximum daily dose Is less than 2 g/day, and the drug Is known generally not to be toxic.
What should be done in response to identifying the impurity?
- A. Perform both identification and non-clinical qualification studies concurrently.
- B. Perform either an identification study or a non-clinical qualification study.
- C. Perform an identification study, wait until the result is available, and then consider performing a
non-clinical qualification study. - D. Perform a non-clinical qualification study, wait until the result is available, and then consider performing
an identification study.
Answer: C
NEW QUESTION 70
A company is developing a new line of products in an area that is new to the company. What is the BEST
approach?
- A. Obtain regulatory documents and history and provide the information to R&D.
- B. Summarize regulatory documents and history and provide the information to the management team.
- C. Ask the trade association representative to provide an overview of the new product area to the
marketing team. - D. Obtain competitor research and provide the information to the management team.
Answer: B
NEW QUESTION 71
A drug product presents degradation during the manufacturing process. In addition to the amount, what
information should be provided FIRST in order to use API overage?
- A. Property
- B. Justification
- C. Formulation
- D. Specification
Answer: B
NEW QUESTION 72
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 III clinical trials
- D. Phase I and II clinical trials
Answer: C
NEW QUESTION 73
Which of the following BEST describes the content of the "Physical, Chemical, and Pharmaceutical
Properties and Formulation" section of an IB?
- A. 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 - 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 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
Answer: A
NEW QUESTION 74
After submission to the regulatory authority, a substantial error was found in the application. In order to
resolve this issue, what should be done FIRST?
- A. Verify the procedure in the regulation for the corrections.
- B. Resubmit the entire package.
- C. Inform upper management immediately.
- D. Contact the legal department and ask them how to proceed.
Answer: A
NEW QUESTION 75
According to WHO, what are the temperature and humidity conditions for a Zone IVb long-term stability
study?
- A. 30c C and 65% RH
- B. 30 C and 35% RH
- C. 30: C and 75% RH
- D. 25: C and 60% RH
Answer: C
NEW QUESTION 76
A protocol for a pivotal registration trial of a new product is submitted to a major regulatory authority for
review and approval. The regulatory authority issues the company a written commitment that if the studies
are completed as outlined in the protocol and the results meet the pre-specified criteria for efficacy and
safety, the product will be approved.
During the final week of the review of the marketing application, which has fully met all pre-specified
criteria, the company receives a letter from the regulatory authority stating that it no longer believes that
the product will be approved based on a recent withdrawal of a similar product in another country.
What is the BEST response?
- A. Notify the regulatory authority regarding Its obligation to honor the commitment to approve the
application. - B. Consult with the legal department to discuss the best course of action.
- C. Review the regulatory guidelines to determine how to proceed.
- D. Request a meeting with the regulatory authority to discuss the application.
Answer: D
NEW QUESTION 77
A regulation change is imminent and may require further non-clinical testing on a product currently in
Phase III clinical trials. What is the most appropriate action to take FIRST?
- A. Inform the company's senior management and arrange an emergency meeting
- B. Obtain a copy of the proposed regulation and analyze the impact.
- C. Consult with the company's legal department regarding options.
- D. Arrange for additional testing of the product at the testing facility.
Answer: B
NEW QUESTION 78
A company establishes a new medical device indication for its consumer disposable products. The
regulatory affairs professional is asked to give a 30-minute training session on these products to sales
representatives. Which of the following subjects is the MOST important to discuss?
- A. Labeling
- B. Safety-related reporting
- C. Regulatory application summary
- D. Risk management process
Answer: A
NEW QUESTION 79
A company is developing a line of products for which no ISO standard of performance is available. As a
result, the company wishes to propose developing such a standard. Whom should the company contact in
order to start the development of the new standard?
- A. The ISO technical committee in charge of the area
- B. The ISO Secretariat
- C. The country's regulatory authority
- D. The ISO national member body
Answer: D
NEW QUESTION 80
Which of the following is NOT considered a serious adverse event in a cardiovascular clinical trial?
- A. Subject's hospitalization is prolonged during the clinical trial.
- B. Subject is hospitalized for the purpose of product administration.
- C. Subject's hospitalization is due to an unscheduled hip operation.
- D. Subject is hospitalized due to complications of the product administration.
Answer: B
NEW QUESTION 81
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