Pass RAC-US Brain Dump Updated Certification Sample Questions
Online RAC-US Test Brain Dump Question and Test Engine
NEW QUESTION 35
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. Request an inspection from a regulatory authority.
- C. Ask the vendor to take responsibility.
- D. Document and perform audits.
Answer: D
NEW QUESTION 36
According to the ICH guideline on GMP for API, to which of the following is the MOST stringent requirement applied?
- A. Isolation and purification
- B. Physical processing and packaging
- C. Introduction of the API starting material
- D. Production of Intermediate(s)
Answer: B
NEW QUESTION 37
A process is ultimately validated to ensure which of the following?
- A. The process meets the regulatory requirements.
- B. The process consistently meets the desired Quantity standards
- C. The process meets the quality system requirements.
- D. The process consistently produces the desired results.
Answer: D
NEW QUESTION 38
A regulatory affairs professional is asked to review and update regulatory affairs SOPs.
Which aspect of the SOP Is MOST important to consider?
- A. Scope and level of detail
- B. Expiration date
- C. Revision history
- D. Relevance to regulations
Answer: D
NEW QUESTION 39
A company is developing a new medical device.
During which initial stage is it MOST appropriate (or a regulatory affairs professional to become involved?
- A. Concept development and early technical design
- B. Early technical design and product release
- C. Concept development and validation
- D. Product release and validation
Answer: A
NEW QUESTION 40
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 company should initiate the required pediatric studies immediately to avoid costly delays to the current registration plan.
- B. The company should consult with relevant regulatory authorities to determine the potential impact on the current registration plan.
- C. The new guideline has no impact on the current registration plan, but the company must be prepared to defend its decision.
- D. The new guideline has no impact on the current registration plan since all relevant registration studies are almost completed.
Answer: B
NEW QUESTION 41
Which of the following situations does NOT require rapid communication to regulatory authorities?
- A. A lack of efficacy with a medicinal product used in treating a life-threatening disease
- B. A clinically important increase in the rate of occurrence of an "expected." but serious
ADR - C. A statistically significant increase in the number of deaths in an animal dose finding study
- D. A major safety finding from a newly completed animal carcinogenicity study
Answer: B
NEW QUESTION 42
A company's product was approved by a regulatory authority with the condition that further studies must be completed prior to full approval of the product.
To minimize product-associated risk to patients during the period of conditional approval, what is the LEAST effective way to achieve this goal?
- A. Promote off-label use to a carefully selected patient population.
- B. Delay product launch until required studies are completed.
- C. Label the product for use in appropriate populations.
- D. Educate patients and healthcare providers on how to use the product
Answer: A
NEW QUESTION 43
According to the GHTF IVD guidance, which of the following is the CORRECT classification for a blood glucose self-testing kit?
- A. Class B
- B. Class A
- C. Class D
- D. Class C
Answer: D
NEW QUESTION 44
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 GMP
- D. Certificate of Analysis for the finished product
Answer: B
NEW QUESTION 45
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. Send a letter back to the regulatory authority indicating why the regulation does not apply to the product.
- C. Initiate testing immediately to ensure compliance.
- D. Contact the regulatory authority that issued this request and discuss the requirement.
Answer: D
NEW QUESTION 46
Which of the following is an example of an acceptable statement for an advertisement of an approved arthritis medication?
- A. "Product X is effective for the treatment of arthritis."
- B. "Product X is effective in all patients with arthritis."
- C. "Product X is safe for arthritis and without side effects."
- D. "Product X is a guaranteed cure for arthritis."
Answer: A
NEW QUESTION 47
Which of the following changes to a drug product is MOST likely to be implemented without prior regulatory authority approval?
- A. Introducing a new analytical method
- B. Deleting an ingredient of the drug product
- C. Strengthening a precaution to the product labeling
- D. Deleting a drug substance
Answer: C
NEW QUESTION 48
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. Failure mode and effect analysis
- B. ISO 14971 risk analysis
- C. Hazard and operability study
- D. Fault tree analysis
Answer: B
NEW QUESTION 49
A company is developing a new line of products in an area that is new to the company.
What is the BEST approach?
- A. Obtain regulatory documents and history and provide the information to R&D.
- B. Ask the trade association representative to provide an overview of the new product area to the marketing team.
- C. Summarize regulatory documents and history and provide the information to the management team.
- D. Obtain competitor research and provide the information to the management team.
Answer: C
NEW QUESTION 50
Who has the PRIMARY responsibility for recall of products with quality defects?
- A. Regulatory authority
- B. Distributor
- C. Consumer
- D. Manufacturer
Answer: D
NEW QUESTION 51
As part of the regulatory strategy for companies intending to manufacture a psychotropic product, which of the following approvals should be received FIRST?
- A. Product license
- B. Export license
- C. Import license
- D. Site license
Answer: D
NEW QUESTION 52
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 both identification and non-clinical qualification studies concurrently.
- B. Perform either an identification study or a non-clinical qualification study.
- C. Perform a non-clinical qualification study, wait until the result is available, and then consider performing an identification study.
- D. Perform an identification study, wait until the result is available, and then consider performing a non-clinical qualification study.
Answer: D
NEW QUESTION 53
A manufacturer is involved in a recall event process for a plasma-derived product. From which stage should the manufacturer be able to trace back the product?
- A. Plasma pooling
- B. Individual plasma donation
- C. Product distribution
- D. Plasma fractionation
Answer: C
NEW QUESTION 54
......
Real RAPS RAC-US Exam Dumps with Correct 100 Questions and Answers: https://www.guidetorrent.com/RAC-US-pdf-free-download.html
RAPS RAC-US Certification Real 2021 Mock Exam: https://drive.google.com/open?id=1pbgy2EdlVF8M6EITjUuiu1N38QdZmxDw