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NEW QUESTION 29
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 Analysis for the finished product
• B. Certificate of Pharmaceutical Product
• C. Certificate of Free Sale
• D. Certificate of GMP

Answer: B

NEW QUESTION 30
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. ISO 14971 risk analysis
• B. Failure mode and effect analysis
• C. Fault tree analysis
• D. Hazard and operability study

Answer: A

NEW QUESTION 31
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 a non-clinical qualification study, wait until the result is available, and then consider performing an identification study.
• B. Perform an identification study, wait until the result is available, and then consider performing a non-clinical qualification study.
• C. Perform either an identification study or a non-clinical qualification study.
• D. Perform both identification and non-clinical qualification studies concurrently.

Answer: B

NEW QUESTION 32
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?

• A. Review the stability data for the changes.
• B. Establish validation procedures.
• C. Assess the impact of the changes.
• D. Stop product manufacturing.

Answer: D

NEW QUESTION 33
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