最新なRAPS RAC-GS問題集（100題）、真実試験の問題を全部にカバー！

質問 1：
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 labelingconversion 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. Convene an urgent meeting with internal stakeholders to inform them of the regulatory authority requirement and assign responsibilities.
D. Request additional resources from senior management in order to complete the labeling conversion within the time frame given by the regulatory authority.
正解：B

質問 2：
A process is ultimately validated to ensure which of the following?
A. The process meets the regulatory requirements.
B. The process meets the quality system requirements.
C. The process consistently meets the desiredQuantity standards
D. The process consistently produces the desired results.
正解：D

質問 3：
The API used for an approved drug product conforms to international monograph specifications and local pharmacopeia; however, the international monograph specifications of the API will be changing soon. Which is the most appropriate action for the regulatory affairs professional to take FIRST?
A. Prepare the international monograph change submission first and then prepare the local change when required.
B. Confirm that the international monograph change is not related to local pharmacopeia.
C. Analyze the impact of the international monograph change on the local pharmacopeia.
D. Transfer the notice of the upcoming international monograph change to QA for further processing.
正解：A,D

質問 4：
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. Formulation
C. Specification
D. Justification
正解：D

質問 5：
According to the ICH guideline on GMP for API,to which of the following is the MOST stringent requirement applied?
A. Introduction of the API starting material
B. Isolation and purification
C. Physical processing and packaging
D. Production of Intermediate(s)
正解：C

質問 6：
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. Quality assurance
B. Quality improvement
C. Regulatory agency
D. Clinical affairs
正解：A

質問 7：
A regulatory affairs professional is asked to review and update regulatory affairs SOPs. Which aspect of the SOP Is MOST important to consider?
A. Expiration date
B. Relevance to regulations
C. Scope and level of detail
D. Revision history
正解：B

質問 8：
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 Analysis for the finished product
C. Certificate of Pharmaceutical Product
D. Certificate of GMP
正解：C