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Download Regulatory Affairs Certification (RAC) Global Scope Exam Dumps
NEW QUESTION 29
Which of the following BEST describes the purpose of the ICH?
- A. To discuss and establish common guidelines for safe, effective, and high-quality medicines for the ICH
regions - B. To lobby for improved industry standards for the development of new safe, effective, and high-quality
medicines for the ICH regions - C. To protect and promote public health through the evaluation and supervision of safe, effective, and
high-quality medicines for the ICH regions - D. To provide scientific evaluation of applications for international marketing authorization for safe,
effective, and high-quality medicines for the ICH regions
Answer: A
NEW QUESTION 30
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 country's regulatory authority
- B. The ISO technical committee in charge of the area
- C. The ISO national member body
- D. The ISO Secretariat
Answer: C
NEW QUESTION 31
Which of the following is the PRIMARY purpose of an audit report?
- A. To document compliance history
- B. To define how to prepare new product submissions
- C. To train sales representatives
- D. To carry out a complete review of product applications
Answer: A
NEW QUESTION 32
An inspection of a manufacturing site determines that a number of manufacturing changes have been
implemented without obtaining the necessary regulatory clearance. Which of the following actions should
the regulatory affairs professional complete FIRST?
- A. Stop product manufacturing.
- B. Review the stability data for the changes.
- C. Assess the impact of the changes.
- D. Establish validation procedures.
Answer: A
NEW QUESTION 33
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. Regulatory agency
- B. Quality improvement
- C. Quality assurance
- D. Clinical affairs
Answer: C
NEW QUESTION 34
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