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デモをダウンロードする

RAPS Regulatory Affairs Certification (RAC) US 認定 RAC-US 試験問題:

1. 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) Production of Intermediate(s)
C) Isolation and purification
D) Physical processing and packaging

2. What are the MOST important elements that global regulatory agencies want to know before approving a new product for sale in their countries?

A) Safety and effectiveness
B) Safety and failure risk
C) Quality and effectiveness
D) Quality and failure risk

3. As a member of the product launch review committee, a regulatory affairs professional discovers a major issue with the labeling of a product prior to production. In addition to informing the committee, which is the BEST approach to address the issue?

A) Inform the regulatory authorities.
B) Abort the product launch.
C) Delay the start of product production.
D) Correct the label text.

4. In the process of obtaining a product approval, a regulatory affairs professional discovers that the product does not meet one of the specific technical requirements of the regulation.
However, competitors with substantially similar products have claimed compliance with the requirement and received approval. Which action should the regulatory affairs professional take FIRST?

A) Notify senior management that the product cannot be registered.
B) Discuss with the regulatory apriority and attempt to reach an acceptable solution.
C) Inform the regulatory authority that such a requirement is not applicable to the product.
D) Inform the internal departments to redesign the product to comply with this requirement.

5. 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) Analyze the impact of the international monograph change on the local pharmacopeia.
B) Prepare the international monograph change submission first and then prepare the local change when required.
C) Transfer the notice of the upcoming international monograph change to QA for further processing.
D) Confirm that the international monograph change is not related to local pharmacopeia.

質問と回答：