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active substance, excipient and primary container ...

6 March 2019. EMA/CHMP/CVMP/QWP/850374/2015. Committee for medicinal Products for Human use (CHMP). Committee for medicinal Products for Veterinary use (CVMP). Guideline on the sterilisation of the medicinal product , active substance , excipient and primary container Draft agreed by QWP and BWP December 2015. Adopted by CHMP for release for consultation January 2016. Adopted by CVMP for release for consultation February 2016. Start of public consultation 13 April 2016. End of consultation (deadline for comments) 13 October 2016.

Container integrity is discussed in ICH Q8, (adopted for human medicinal products only, nevertheless the same principles are also applicable to veterinary medicinal products and containers of sterile substances and containers). 2. Scope The guideline applies to chemical and biological medicinal products for human and veterinary use but is

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