EMA's Concept Paper on the Selection of suitable Sterilisation Processes

According to the EMA, the currently available documents on the selection of suitable sterilisation processes have become obsolete since in the meantime essential items have been developed in more recent documents (like ICH Q8). The EMA has therefore proposed to withdraw the Guideline CPMP/QWP/155/96 "Note for Guidance on Development Pharmaceutics" and to develop a new guideline instead which describes the decision tree for the selection of sterilisation methods. The latter is currently available as annex (CPMP(QWP/054(98) of the guideline named. The new document should apply to human and veterinary medicinal products. At the moment, there has been no planned proposal to withdraw the veterinary development pharmaceutics guideline (EMEA/CVMP/315/98) as the ICH documents don't include veterinary medicinal products within their scopes.

Among other things, the following aspects should be taken into consideration:

  • Specifying conditions when aseptic processing could be accepted
  • Requirements for justification of the choice of sterilisation method
  • Possible combination with terminal processes to provide a limited sterilisation assurance level (= reduction of bio burden)
  • Gas sterilisation processes
  • Sterilisation of medicinal products with a very short shelf-life
  • Revision of the decision tree
  • Necessity of biological validation of terminal sterilisation processes

In the next three months, the Quality Working Party in charge of the document will be collecting all comments to this concept paper. After that, they will publish a guideline which - in turn - will undergo a 6-month consultation period.

Please also see EMA's concept paper "Establishment of a guideline on the selection of sterilisation processes for drug products".

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