本帖最后由 volador 于 2017-8-23 11:28 编辑
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
For further details, see: http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_001431.jsp&mid=WC0b01ac0580028e8b | 
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发表于 2016-3-6 14:20:27
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