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RAPS Regulatory Affairs Certification (RAC) US RAC-US Exam Questions in PDF

Free RAPS RAC-US Dumps Questions (page: 2)

RAC-US PDF — 100 Questions

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

  1. 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 formulation
  2. 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
  3. A description and flow chart illustrating the synthetic route for the active ingredient and the preparation method of the finished product
  4. 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(s): D



What are the MOST important elements that global regulatory agencies want to know before approving a new product for sale in their countries?

  1. Safety and failure risk
  2. Safety and effectiveness
  3. Quality and failure risk
  4. Quality and effectiveness

Answer(s): B



A materials supplier informs a company that it intends to stop supplying a material critical to the manufacture of the company's products. What action should the company take FIRST?

  1. Review the company's existing Quality Management System
  2. Reformulate the products with a replacement material.
  3. Qualify another supplier and execute a supplier agreement.
  4. Complete a gap analysis to identify options.

Answer(s): C



In a distribution contract for high-risk medical devices, which of the following regulatory requirements is the MOST important for the distributor?

  1. Local reimbursement requirements
  2. Service operation procedures
  3. Training program for sales people
  4. Written procedure for product traceability

Answer(s): C



According to ICH, how many stability time points are normally required to establish a two- year shelf life for a product?

  1. 3
  2. 5
  3. 7
  4. 9

Answer(s): C



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J
John
8/29/2023 8:59:00 PM

very helpful

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V
Vnu
6/3/2023 2:39:00 AM

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Yves
8/29/2023 8:46:00 PM

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Samir
8/1/2023 3:07:00 PM

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K
Kenneth
12/8/2023 7:34:00 AM

thank you for the test materials!

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