Registered content for S.4.2 analytical procedures

Delivered at BioProcess East, Boston, September 2019, this presentation details the conclusions from a survey and discussions about this topic. 

Designed, completed and discussed by 14 leading biopharmaceutical companies of the CMC Regulatory subteam, the purpose of the survey was to determine companies' approaches to S.4.2 section content. More specifically:

  • What content different companies providing within each subsection of S.4.2 for non-compendial methods?
  • Understand to what extent the level of information provided in core dossiers can be aligned between countries, to minimize the need for global document lifecycle management?
  • If specific feedback from any countries been provided to indicate what content is required?

Summarizing the S.4.2 section content that has been found to be generally adequate for biologics marketing applications.

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