Exit RAC-GS Regulatory Affairs Certification (RAC) Global Scope
Question 2 of 5
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Q2 Single choice

The manufacturer of an API was changed from Company X to Company Y during the late stage of a new drug development. Despite differences in the manufacturing processes of the companies, both APIs meet the current specifications.

Which is the MOST appropriate information to include in the final submission documents?

  • A

    The process information and analytical result of Company X API

  • B

    The process information and analytical result of Company Y API

  • C

    The process information and the comparative analytical result of APIs from both companies

  • D

    Information deemed appropriate by the regulatory authority

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