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NEW QUESTION 45
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 methodB. Deleting an ingredient of the drug productC. Deleting a drug substanceD. Strengthening a precaution to the product labeling

Answer: D

 

NEW QUESTION 46
According to WHO, what are the temperature and humidity conditions for a Zone IVb long-term stability
study?

A. 30c C and 65% RHB. 30 C and 35% RHC. 25: C and 60% RHD. 30: C and 75% RH

Answer: D

 

NEW QUESTION 47
Who has the PRIMARY responsibility for recall of products with quality defects?

A. ConsumerB. DistributorC. ManufacturerD. Regulatory authority

Answer: C

 

NEW QUESTION 48
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?

A. Prepare documents for the files.B. Communicate with the relevant internal departments.C. Contact the trade association for advice.D. Request a permanent waiver from the new regulation.

Answer: B

 

NEW QUESTION 49
A regulatory authority announces an inspection of a regulatory affairs professional's facility during a
holiday season when most of the staff Is not available. What is the MOST practical approach to this
dilemma?

A. Arrange for an inspection without all intended personnel.B. Insist that key personnel be available for the inspection.C. Inform the authority that the time is not suitable and request a new timeD. Negotiate with colleagues and the authority to find a better time.

Answer: D

 

NEW QUESTION 50
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