[2026] Pass RAPS RAC-US Test Practice Test Questions Exam Dumps [Q29-Q48]

Q29. The intermediate manufacturing process was changed during development of a pharmaceutical. The change may impact the API specification. Which functional area is responsible for the final approval of the change?

Q30. 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?

Q31. A global company is developing a sophisticated implantable medical device that is coated with antibiotics and biologics to enhance its efficacy.
The product is marketed in Country X.
where it is regulated as a medical device.
The same product, without the antibiotics and biologics, is marketed as a medical device in Country Y.
The company is proposing to start marketing the coated device in Country Y.
Which regulatory approach should the company propose?

Q32. 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?

Q33. Which analysis method is MOST appropriate to prioritize risk and monitor the effectiveness of risk control activities for a medical device?

Q34. Which of the following claims would classify an apple as a drug?

Q35. 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?

Q36. In which section of the ICH Common Technical Document will the overview of clinical data appear?

Q37. After numerous failed attempts to decrease an identified risk in a medical device to an acceptable level, the medical device continues to have unacceptable risks. However, the development team wants to continue development. Which is the BEST recommendation to make in this situation?

Q38. The requirements for document control are located in which of the following documents?

Q39. A protocol for a pivotal registration trial of a new product is submitted to a major regulatory authority for review and approval. The regulatory authority issues the company a written commitment that if the studies are completed as outlined in the protocol and the results meet the pre-specified criteria for efficacy and safety, the product will be approved.
During the final week of the review of the marketing application, which has fully met all pre- specified criteria, the company receives a letter from the regulatory authority stating that it no longer believes that the product will be approved based on a recent withdrawal of a similar product in another country.
What is the BEST response?

Q40. 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?

Q41. In order to develop a global drug product, what is the MOST important environmental characteristic to consider in the country of intended use?

Q42. During an audit of a contract manufacturing facility by a potential client, the auditor requested to be left alone in the records room. The records room contains information on all products produced by the contract manufacturer.
Which action is MOST appropriate for the regulatory affairs professional to take?

Q43. A company receives multiple complaints regarding the text included on a recently launched product’s label. What action should the regulatory affairs professional take FIRST?

Q44. The safety database for an anti-hypertensive drug consists of the following:
* 461 patients exposed for three months
* 343 patients exposed for six months
* 112 patients exposed for nine months
* 74 patients exposed for 12 months
Overall exposure is 2.000 patients. Which long-term ICH data requirement has NOT been met?

Q45. 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?

Q46. According to ICH, how many stability time points are normally required to establish a two- year shelf life for a product?

Q47. According to the GHTF, which of the following is NOT an exemption rule when evaluating the decision to report an adverse event?

Q48. A process is ultimately validated to ensure which of the following?