최신RAPS Regulatory Affairs Certification (RAC) Global Scope - RAC-GS무료샘플문제
문제1
SOPs for preventive and corrective actions MUST include the procedure to eliminate which of the following?
SOPs for preventive and corrective actions MUST include the procedure to eliminate which of the following?
정답: A
문제2
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 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?
정답: A
문제3
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 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?
정답: A
문제4
Which of the following is MOST appropriate for the purpose of lot release of biologics?
Which of the following is MOST appropriate for the purpose of lot release of biologics?
정답: C
문제5
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?
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?
정답: A,D
문제6
The manufacturer of an API was changed from Company X to Company Y during the late stage of a new drug development. Despite differences in the manufacturing processes of the companies, both APIs meet the current specifications. Which is the MOST appropriate information to include in the final submission documents?
The manufacturer of an API was changed from Company X to Company Y during the late stage of a new drug development. Despite differences in the manufacturing processes of the companies, both APIs meet the current specifications. Which is the MOST appropriate information to include in the final submission documents?
정답: B
문제7
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?
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?
정답: A,C
문제8
A company is considering the development of a medical device similar to those already available. Which of the following should be evaluated FIRST when developing a clinical evaluation document?
A company is considering the development of a medical device similar to those already available. Which of the following should be evaluated FIRST when developing a clinical evaluation document?
정답: A
문제9
According to ICH, what is the MAXIMUM amount of timein calendar days that anorganizationhas from the initial receipt of information to report serious and unexpected ADR of a marketed product to regulatory authorities?
According to ICH, what is the MAXIMUM amount of timein calendar days that anorganizationhas from the initial receipt of information to report serious and unexpected ADR of a marketed product to regulatory authorities?
정답: B,C,D
문제10
GHTF recommends that the medical device manufacturer define the scope of the clinical evaluation based on which of the following?
GHTF recommends that the medical device manufacturer define the scope of the clinical evaluation based on which of the following?
정답: B,C