2022 Valid RAC-GS Real Exam Questions (Updated) 100% Dumps & Practice Exam
[UPDATED 2022] RAPS RAC-GS Questions Prepare with Free Demo of PDF
NEW QUESTION 46
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. Qualify another supplier and execute a supplier agreement.
- B. Review the company's existing Quality Management System
- C. Complete a gap analysis to identify options.
- D. Reformulate the products with a replacement material.
Answer: A
NEW QUESTION 47
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 48
A global company has obtained a patent in a specific country for a newly marketed product. What would
be the BEST advice In order to protect the patent in other countries?
- A. File design patents in target countries.
- B. Use the Madrid system.
- C. File patents of interest in target countries.
- D. Use the community patent system.
Answer: C
NEW QUESTION 49
During an audit of a contract manufacturing facility by a potential client, the auditor requested to be left
alone in the records room. The records room contains information on all products produced by the
contract manufacturer.
Which action is MOST appropriate for the regulatory affairs professional to take?
- A. Allow the auditor accompanied access to the room to retrieve the records.
- B. Allow the auditor access to the room and records due to the current audit.
- C. Deny the auditor access to the room and retrieve only the requested records.
- D. Deny the auditor access to the room and records due to confidentiality concerns.
Answer: A
NEW QUESTION 50
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. Wait for the regulatory authority's final publication on its findings.
- C. Contact the regulatory authority to discuss its findings.
- D. Contact the regulatory authority to argue that its conclusions are wrong.
Answer: C
NEW QUESTION 51
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. Analytical
- B. Regulatory
- C. Quality
- D. Production
Answer: C
NEW QUESTION 52
Which of the following claims would classify an apple as a drug?
- A. "It will make you look younger."
- B. "It will prevent colds."
- C. "It will satisfy hunger."
- D. "It will whiten teeth."
Answer: B
NEW QUESTION 53
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 54
SOPs for preventive and corrective actions MUST include the procedure to eliminate which of the
following?
- A. Adverse environmental impacts
- B. Causes of non-conformities
- C. Inadequate training
- D. Late and/or incorrect deliverables
Answer: B
NEW QUESTION 55
Which term does NOT describe the same concept as the others?
- A. Monoclonal antibody
- B. Subsequent entry biologics
- C. Follow-on protein products
- D. Biosimilars
Answer: A
NEW QUESTION 56
Company X and Company Y both have products for the treatment of rare genetic diseases. Company X
would like to acquire Company Y but does not know enough about Company Y to make an offer.
What is the MOST appropriate approach that Company X should take to acquire more information about
Company Y?
- A. Perform a thorough library search to gather detailed information on Company Y.
- B. Enter into an agreement with Company Y to perform due diligence.
- C. Request the needed information from the Board of Directors of Company Y.
- D. Recruit a professional to gather confidential intelligence on Company Y.
Answer: B
NEW QUESTION 57
Which of the following double-blind clinical trial designs would be MOST appropriate for a Phase III study
with a new product intended to treat an acute life-threatening disease with less than optimal available
therapy?
- A. Cross-over
- B. Dose-ranging
- C. Placebo-controlled
- D. Active-controlled
Answer: A
NEW QUESTION 58
Company X encounters challenges in the global life cycle management of its medical devices. Which of
the following Is MOST appropriate for improving product life cycle management?
- A. Plan regulatory approval update meetings with senior management and stakeholders.
- B. Identify countries where special requirements exist during the product development phase.
- C. Initiate a global submission process after all submission data are finalized.
- D. Utilize the STED template to complete global requirements.
Answer: B
NEW QUESTION 59
Which of the following criteria is MOST appropriate to define the animal species needed for the
pre-clinical toxicity testing of a biotechnology product?
- A. Immunochemical and functional tests
- B. Biological activity with species and/or tissue specificity
- C. Proposed dose and volume of administration
- D. Proposed product route and frequency of administration
Answer: B
NEW QUESTION 60
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. Safety issues
- B. Clinical trial data
- C. Intellectual properly
- D. Marketing materials
Answer: A
NEW QUESTION 61
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 62
During a regulatory authority inspection of a manufacturing site, the inspector observes that one of the
medicinal products manufactured at the site is not GMP compliant. The product Is distributed globally.
Which of the following is the most appropriate action to take FIRST?
- A. Assess the potential safety risk.
- B. Withdraw the affected product from the markets.
- C. Notify the global regulatory authorities.
- D. Send a "Dear Dr." letter to customers.
Answer: C
NEW QUESTION 63
GHTF recommends that the medical device manufacturer define the scope of the clinical evaluation
based on which of the following?
- A. Risk analysis
- B. Essential principles
- C. Instructions for use
- D. Product literature
Answer: A
NEW QUESTION 64
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. Allow doctors to use the product for the off-label indication.
- B. Request that doctors stop using the product for the off-label indication.
- C. Contact the marketing department to recall the product.
- D. Communicate with the sales department to stop using the promotional materials.
Answer: D
NEW QUESTION 65
Which of the following is NOT required to be included in a marketing application?
- A. Final printed label
- B. Evidence of fee payment
- C. Administrative forms
- D. Quality, safety, and efficacy Information
Answer: B
NEW QUESTION 66
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 67
During face-to-face meetings with the regulatory authority to address submission issues, what is the
BEST choice for the number of company representatives who should attend?
- A. The minimum number of attendees necessary to address the issues
- B. As many as government attendees
- C. As many as required by international standards
- D. All senior management from the main office
Answer: A
NEW QUESTION 68
Company X has a patent for an anti-inflammatory drug that will expire in one year. In order to minimize the
effect of the patent expiration, which is the BEST action for the company to take?
- A. Develop a better brand-name drug in the same class.
- B. Develop a generic version of the drug.
- C. Explore litigation strategy for patent infringements on the drug.
- D. Conduct a Phase III study for a new unrelated indication of the drug.
Answer: B
NEW QUESTION 69
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 70
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 71
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