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NEW QUESTION 29
The requirements for document control are located in which of the following documents?

A. WHO guidelinesB. ISO 13485C. ICH guidelinesD. IEC 60601

Answer: B

 

NEW QUESTION 30
After submission to the regulatory authority, a substantial error was found in the application. In order to resolve this issue, what should be done FIRST?

A. Resubmit the entire package.B. Verify the procedure in the regulation for the corrections.C. Inform upper management immediately.D. Contact the legal department and ask them how to proceed.

Answer: B

 

NEW QUESTION 31
Which of the following BEST describes the content of the "Physical, Chemical, and
Pharmaceutical Properties and Formulation" section of an IB?

A. 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 useB. A description and flow chart illustrating the synthetic route for the active ingredient and the preparation method of the finished productC. 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 brief summary of relevant physical, chemical, and pharmaceutical properties:
instructions for storage and handling of the dosage form: and a description of the formulation

Answer: D

 

NEW QUESTION 32
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