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最新的 RAC Regulatory Affairs Certification RAC-GS 免費考試真題:

1. After submission to the regulatory authority, a substantial error was found in the application. In order to resolve this issue, what should be done FIRST?

A) Contact the legal department and ask them how to proceed.
B) Inform upper management immediately.
C) Resubmit the entire package.
D) Verify the procedure in the regulation for the corrections.

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

3. A request was received from a regulatory authority asking the company to conduct product testing in compliance with a newly issued regulation.
What should be done. What action should the company take FIRST?

A) Consult with colleagues about the request.
B) Initiate testing immediately to ensure compliance.
C) Send a letter back to the regulatory authority indicating why the regulation does not apply to the product.
D) Contact the regulatory authority that issued this request and discuss the requirement.

4. 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

5. 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 Pharmaceutical Product
C) Certificate of Analysis for the finished product
D) Certificate of GMP

問題與答案：