If there is no change in the materials, manufacturing process and process control, then the following information is suggested to be provided:

1. Process validation and/or evaluation studies and information demonstrating requalification of the equipment or requalification of the change, as appropriate.
2. Results for at least 3 batches of the approved and proposed drug product summarized by items in a tabular format, as well as the results of comparative accelerated or stress studies.
3. Real time/real temperature stability testing result on drug product manufactured in the proposed manufacturing facility.

(中文版)