Updated Oct-2021 Test Engine to Practice Test for RAC-GS Exam Questions and Answers!
Regulatory Affairs Certification (RAC) Global Scope Certification Sample Questions and Practice Exam
NEW QUESTION 43
The regulatory authority contacts the regulatory affairs professional regarding a complaint about a drug
produced by the company. A consumer reported to the regulatory authority that the tablets have a slightly
different color and break easily.
Which of the following actions should the regulatory affairs professional take?
- A. Ask that the regulatory authority provide the batch number printed on the packaging of the affected
product. - B. Respond to the regulatory authority that the company will provide copies of the relevant QC records for
batch release. - C. Respond to the regulatory authority that the product subject to the complaint is most likely a counterfeit
product. - D. Ask that the regulatory authority provide the actual product subject to the complaint.
Answer: A
NEW QUESTION 44
A manufacturer is involved in a recall event process for a plasma-derived product. From which stage
should the manufacturer be able to trace back the product?
- A. Product distribution
- B. Individual plasma donation
- C. Plasma fractionation
- D. Plasma pooling
Answer: A
NEW QUESTION 45
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 published scientific journals
- C. Systematic procedure to review experiences with the products in use
- D. Vigilance procedure to ensure the full traceability of the products
Answer: D
NEW QUESTION 46
According to the ICH guideline on GMP for API, to which of the following is the MOST stringent
requirement applied?
- A. Isolation and purification
- B. Production of Intermediate(s)
- C. Introduction of the API starting material
- D. Physical processing and packaging
Answer: D
NEW QUESTION 47
Which of the following is MOST appropriate for the purpose of lot release of biologics?
- A. Efficacy confirmation
- B. Inventory control
- C. Safety assurance
- D. Quality verification
Answer: D
NEW QUESTION 48
According to the GHTF, which of the following is NOT an exemption rule when evaluating the decision to
report an adverse event?
- A. Deficiency of a device found by the user prior to patient use
- B. Malfunction occurring before the end of service life of the medical device
- C. Malfunction protection operated correctly
- D. Adverse event caused by patient conditions
Answer: D
NEW QUESTION 49
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. Send a "Dear Dr." letter to customers.
- C. Withdraw the affected product from the markets.
- D. Notify the global regulatory authorities.
Answer: D
NEW QUESTION 50
What is the LAST stage in the development of a quality risk management process for a medical device?
- A. Risk reduction
- B. Risk evaluation
- C. Risk acceptance
- D. Risk analysis
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. Regulatory
- B. Quality
- C. Analytical
- D. Production
Answer: B
NEW QUESTION 52
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. 3.000 total patient exposures
- B. 100 patients for 12 months
- C. 500 patients for three months
- D. 200 patients for nine months
Answer: B
NEW QUESTION 53
Which of the following is the BEST approach for mitigating potential regulatory compliance issues at your
company?
- A. Train all new employees on regulatory compliance processes and assign a mentor to them.
- B. Document any failure to follow regulatory compliance processes in employee performance reviews.
- C. Develop documented procedures for regulatory compliance processes and train personnel.
- D. Train employees on all regulatory compliance processes using state-of-the-art systems.
Answer: C
NEW QUESTION 54
Under which of the following circumstances would a regulatory authority require a more detailed
premarket submission, a more rigorous audit, and/or the provision of more performance evaluation data
than would normally apply to an IVD device of that risk class?
- A. The device is an updated version of a compliant device from the same manufacturer and contains no
substantive change. - B. The manufacturer's experience level with the type of IVD medical device is limited.
- C. Internationally recognized standards are available to cover the main aspects of the device and have
been used by the manufacturer. - D. The device incorporates well-established technology that is already present in the market.
Answer: B
NEW QUESTION 55
A company is developing a device-drug combination product. Which of the following should be evaluated
FIRST in order to determine the applicable guidance documents?
- A. Guidance documents for the device
- B. Determination of primary mode of action
- C. Determination of product design deliverables
- D. Approved indications of the drug
Answer: C
NEW QUESTION 56
At the last internal audit, a regulatory affairs professional identified a need for a corrective action for the
manufacturing process. Which of the following stakeholders should be notified FIRST?
- A. Clinical affairs
- B. Quality improvement
- C. Quality assurance
- D. Regulatory agency
Answer: C
NEW QUESTION 57
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 Analysis for the finished product
- B. Certificate of Free Sale
- C. Certificate of Pharmaceutical Product
- D. Certificate of GMP
Answer: C
NEW QUESTION 58
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. After the enactment of the regulation, through a product-specific meeting
- B. Before the enactment of the regulation, through formal comments gathering process
- C. Before the enactment of the regulation, through the industry representative
- D. After the enactment of the regulation, through the industry representative
Answer: B
NEW QUESTION 59
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. Contact the regulatory authority to argue that its conclusions are wrong.
- B. Repeat the Hepatotoxicity tests and send the results to the regulatory authority.
- C. Wait for the regulatory authority's final publication on its findings.
- D. Contact the regulatory authority to discuss its findings.
Answer: D
NEW QUESTION 60
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. Deny the auditor access to the room and retrieve only the requested records.
- B. Allow the auditor accompanied access to the room to retrieve the records.
- C. Allow the auditor access to the room and records due to the current audit.
- D. Deny the auditor access to the room and records due to confidentiality concerns.
Answer: B
NEW QUESTION 61
Why is it necessary to run supplemental safety pharmacology studies?
- A. To evaluate potential adverse pharmacodynamics effects not addressed by the core battery
- B. To comply with regulatory authority requirements related to clinical studies
- C. To substitute the utilization of GLP
- D. To provide adverse reaction reports and the results of the statistical data to the regulatory authority
Answer: A
NEW QUESTION 62
According to WHO, what are the temperature and humidity conditions for a Zone IVb long-term stability
study?
- A. 30 C and 35% RH
- B. 30c C and 65% RH
- C. 30: C and 75% RH
- D. 25: C and 60% RH
Answer: C
NEW QUESTION 63
SOPs for preventive and corrective actions MUST include the procedure to eliminate which of the
following?
- A. Inadequate training
- B. Late and/or incorrect deliverables
- C. Causes of non-conformities
- D. Adverse environmental impacts
Answer: C
NEW QUESTION 64
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. Regulatory application summary
- B. Risk management process
- C. Labeling
- D. Safety-related reporting
Answer: C
NEW QUESTION 65
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. Proposed dose and volume of administration
- B. Biological activity with species and/or tissue specificity
- C. Proposed product route and frequency of administration
- D. Immunochemical and functional tests
Answer: B
NEW QUESTION 66
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