Referential Testing Methods by FDA's presentation

At a recent workshop on Nitrosamine Impurities, Dr. David Keire (CDER-FDA) shared a list of referential testing methods. It was also clearly stated that “any method should be validated by the user if the resulting data are used to support a required quality assessment of the API or drug product, or if the results are used in a regulatory submission”.

  • What testing methods is your team/organization using?
  • FDA/USP/EP Methods
  • In-house developed Methods
  • Instrument manufacture Methods
  • API/Excipient/DP supplier Methods

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