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最新的 RAC Regulatory Affairs Certification RAC-GS 免費考試真題:
1. 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) Review the stability data for the changes.
B) Stop product manufacturing.
C) Establish validation procedures.
D) Assess the impact of the changes.
2. 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?
A) The process information and analytical result of Company X API
B) Information deemed appropriate by the regulatory authority
C) The process information and analytical result of Company Y API
D) The process information and the comparative analytical result of APIs from both companies
3. 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) Contact the regulatory authority to discuss its findings.
C) Contact the regulatory authority to argue that its conclusions are wrong.
D) Wait for the regulatory authority's final publication on its findings.
4. 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) Complete a gap analysis to identify options.
B) Reformulate the products with a replacement material.
C) Review the company's existing Quality ManagementSystem
D) Qualify another supplier and execute a supplier agreement.
5. Which of the following BEST describes the purpose of the ICH?
A) To protect and promote public health through the evaluation and supervision of safe,effective, and high-quality medicines for the ICH regions
B) To lobby for improved industry standards for the development of new safe, effective, andhigh-quality medicines for the ICH regions
C) To provide scientific evaluation of applications for international marketing authorization forsafe, effective, and high-quality medicines for the ICH regions
D) To discuss and establish common guidelines for safe, effective, and high-quality medicines for the ICH regions
問題與答案:
| 問題 #1 答案: B,D | 問題 #2 答案: D | 問題 #3 答案: B | 問題 #4 答案: A,D | 問題 #5 答案: D |


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在上個月,我購買了 RAPS 的 RAC-GS 學習指南考試培訓資料,才順利的通過了我的考試。在我準備考試的時候,這個題庫是非常有效果的,它讓我非常容易的理解了很多問題。