Monday, 7 July 2014

Guideline on the selection of sterilisation processes for drug products



The European Medicines Agency (EMA) has proposed to withdraw the Guideline CPMP/QWP/155/96 "Note for Guidance on Development Pharmaceutics" and to develop a new guideline which will describe the decision tree for the selection of sterilisation methods. The latter is currently available as annex (CPMP(QWP/054(98).

The new document will 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).

With the new guideline, the following aspects are recommended to 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


Thanks to the ECA for notification of this change.

Posted by Tim Sandle

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