Table of Contents Table of Contents
Previous Page  136 / 197 Next Page
Information
Show Menu
Previous Page 136 / 197 Next Page
Page Background

IV. General Submission Package

1. Based on the supporting information, were there any additional steps in the evaluation of the

method that indicated the need for any additional precautionary statements in the method?

2. Does the method contain system suitability tests or controls as specified by the SMPR? If

no, please indicate if there is a need for such tests or controls and which ones.

3. Is there information demonstrating that the method system suitability tests and controls as

specified in the SMPR worked appropriately and as expected? If not, please specify.

4. Based on the supporting information, is the method written clearly and concisely? If not,

please specify the needed revisions.