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Download Regulatory Affairs Certification (RAC) US Exam Dumps
NEW QUESTION 28
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?
Answer: A
NEW QUESTION 29
According to the GHTF, which of the following is NOT an exemption rule when evaluating the decision to report an adverse event?
Answer: D
NEW QUESTION 30
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?
Answer: A
NEW QUESTION 31
What is the BEST approach to ensure that raw materials, services, and sub-contractors at the level of the vendors comply with GMP requirements?
Answer: C
NEW QUESTION 32
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