The purge factor - ICH M7 Option 4
Автор: Fernanda Waechter
Загружено: 2019-11-09
Просмотров: 27756
Описание:
This video explains and gives an example of how to calculate the purge factor to support the adoption of Option 4 control strategy as described in ICH M7.
To watch the first video about ICH M7, follow the below link:
• ICH M7 - Risk assessment for mutagenic imp...
To know more about Mirabilis, visit https://www.lhasalimited.org/
Note: There are discussions currently taking place to reach an agreement on the best practice for solubility purges. Considering these current discussions for the example presented in this video, the solubility purges immediately following precipitation purges would not be assigned any factor.
This is a conservative approach, hence tends to be more easily accepted by regulators, and it is based on the fact that the second operation - filtration stage in this case - is only a consequence of the separation obtained in the precipitation stage (which in fact separates the solid from the liquid phase).
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