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Guidance 11: Drug Master Files and Certificates of Suitability of a Monograph of the European Pharmacopoeia for drug substances

9 August 2013

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11.9 Other information that may be requested by the TGA in relation to certificates of suitability

The TGA may request:

  • additional information about the manufacture and quality control of the drug substance
  • additional information about how the impurity limits specified in the CEP have been justified by the manufacturer and assessed by the EDQM
  • copies of the EDQM evaluation report parts A and B and any related correspondence between the manufacturer and the EDQM
  • validation data for use of the drug substance in the drug product, where relevant.

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