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EMA published a Draft guideline on the sterilisation of the medicinal product, active substance, excipient and primary container (Part I)

  • 29 June 2016
  • Annex 1, API, aseptic processing, excipients, filtration, finished dosage form, GMP, medicinal product, primary container, SAL, sterilisation, sterilisation assurance level, sterility, terminal sterilisation,
On 13 April 2016, EMA released for 6 months public consultation the Draft guideline on the sterilisation of the medicinal product, active substance, excipient and primary container. A new guidance is developed as a separate guidance document and will replace Decision trees for the selection of sterilisation methods (CPMP/QWP/054/98) and Decision trees for the selection
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