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

1. What is the BEST approach to ensure that raw materials, services, and sub-contractors at the level of the vendors comply with GMP requirements?

A) Request documentation from the sub-contractor.
B) Ask the vendor to take responsibility.
C) Request an inspection from a regulatory authority.
D) Document and perform audits.

2. During the review of a design dossier, the reviewer asks why the company has only carried out a top-down risk approach. The reviewer is referring to which of the following?

A) Hazard and operability study
B) Failure mode and effect analysis
C) Fault tree analysis
D) ISO 14971 risk analysis

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

4. During a regulatory authority inspection of a manufacturing site, the inspector observes that one of the medicinal products manufactured at the site is not GMP compliant. The product
Is distributed globally.
Which of the following is the most appropriate action to take FIRST?

A) Notify the global regulatory authorities.
B) Send a "Dear Dr." letter to customers.
C) Withdraw the affected product from the markets.
D) Assess the potential safety risk.

5. A company is developing a new product for the global market. A new international guideline will recommend relevant studies in the pediatric population, and the guideline will be effective before the approval of the company's new product.
What is the BEST advice the regulatory affairs professional can provide to minimize the impact of this guideline on the successful registration of the new product?

A) The new guideline has no impact on the current registration plan since all relevant registration studies are almost completed.
B) The company should consult with relevant regulatory authorities to determine the potential impact on the current registration plan.
C) The company should initiate the required pediatric studies immediately to avoid costly delays to the current registration plan.
D) The new guideline has no impact on the current registration plan, but the company must be prepared to defend its decision.

問題與答案：