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. Agreed by BWP July 2018. Agreed by CAT September 2018. Agreed by QWP and GMDP IWG October 2018. Adopted by CHMP for publication 15 November 2018. Adopted by CVMP for publication 6 December 2018.

outside of the container sterile) is used to provide a specific protection to the medicinal product, the packaging process should be described, including a risk assessment, since it may affect the sterility of the finished product; for example, trapping moisture between the primary and secondary containers.

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  Product, Active, Primary, Excipients, Medicinal, Container, Substance, Medicinal products, Active substances, Excipient and primary container

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