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Download Regulatory Affairs Certification (RAC) US Exam Dumps
NEW QUESTION 23
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?
Answer: D
NEW QUESTION 24
In which section of the ICH Common Technical Document will the overview of clinical data appear?
Answer: B
NEW QUESTION 25
Which of the following BEST describes the content of the "Physical, Chemical, and
Pharmaceutical Properties and Formulation" section of an IB?
instructions for storage and handling of the dosage form: and a description of the formulationC. A review of available data to support the determination of the chemical structure and physical attributes of the drug substance plus batch analysis and stability data for the finished formulationD. A detailed summary of the physical and chemical properties of the drug product with a signed expert statement addressing the suitability and stability of the formulation for its intended use
Answer: B
NEW QUESTION 26
Following the introduction of a new regulation, an evaluation of the company's products by the regulatory affairs professional indicates that 60 percent do not comply with the regulation.
What should the regulatory affairs professional do FIRST to meet the new requirement?
Answer: A
NEW QUESTION 27
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