RAC-US Online Practice Questions and Answers

In order to develop a global drug product, what is the MOST important environmental characteristic to consider in the country of intended use?

A. Product stability

B. Product registration

C. Product formulation

D. Product requirements

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. Review the company's existing Quality ManagementSystem

B. Reformulate the products with a replacement material.

C. Qualify another supplier and execute a supplier agreement.

D. Complete a gap analysis to identify options.

When applying for marketing approval of a drug for a rare disease, which requirement can be waived?

A. Pre-clinical studies

B. Phase I clinical trials

C. Phase I and II clinical trials

D. Phase III clinical trials

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 GMP

B. Certificate of Free Sale

C. Certificate of Pharmaceutical Product

D. Certificate of Analysis for the finished product

A company establishes a new medical device indication for its consumer disposable products. The regulatory affairs professional is asked to give a 30-minute training session on these products to sales representatives. Which of the following subjects is the MOST important to discuss?

A. Labeling

B. Regulatory application summary

C. Risk management process

D. Safety-related reporting

A company is developing a novel drug to combat AIDS. The preliminary results are very promising and include instances of complete remission. The company has been granted patents in multiple countries for the drug. The regulatory affairs professional is asked to prepare a brief report concerning potential problems for marketing of the product worldwide. Which of the following is the MOST important consideration to discuss?

A. Doha Declaration in the TRIPS Agreement

B. The stability of the drug in all zone conditions

C. The time frame in which the patent will expire

D. International import and export regulations

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. Contact the regulatory authority, ask for clarification about the delay, and provide answers to any outstanding questions.

B. Contact the regulatory authority, ask for clarification about the delay, and demand a decision be made regarding the submission.

C. Contact the local political representative and ask for intervention with the regulatory authority to obtain a decision regarding the submission.

D. Contact the company legal representative in order to begin legal proceedings to enforce the regulatory authority's response time.

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. Specification

B. Formulation

C. Property

D. Justification

The requirements for document control are located in which of the following documents?

A. ICH guidelines

B. IEC 60601

C. ISO 13485

D. WHO guidelines

During new drug development, a new impurity in the drug substance is detected at a level of 0.12%. The intended maximum daily dose Is less than 2 g/day, and the drug Is known generally not to be toxic.

What should be done in response to identifying the impurity?

A. Perform either an identification study or a non-clinical qualification study.

B. Perform both identification and non-clinical qualification studies concurrently.

C. Perform an identification study, wait until the result is available, and then consider performing a non-clinical qualification study.

D. Perform a non-clinical qualification study, wait until the result is available, and then consider performing an identification study.