Amended European guidelines open up new approaches for the production of Water for Injection. The new regulations nonetheless raise questions about how to implement the new process. An expert group within the International Society for Pharmaceutical Engineering (ISPE) has taken on the issue and developed a common understanding of the manufacturing process requirements.
The European Pharmacopoeia Commission decided in 2016 to permit use of the cold method for the manufacture of Water for Injection (WFI), which is utilized primarily to produce injection and infusion solutions. Since coming into effect in 2017, the new resolution allows European manufactures to use not
The European Pharmacopoeia Commission decided in 2016 to permit use of the cold method for the manufacture of Water for Injection (WFI), which is utilized primarily to produce injection and infusion solutions. Since coming into effect in 2017, the new resolution allows European manufactures to use not
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