For biologics, what information should be provided for the change involving a drug product manufacturer/manufacturing facility?

刊登日期:2019-06-26  |  點閱次數 : 1228 次 

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.



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