NanoViricides Inc. (NNVC)

[leifsmith]

"Chemistry, Manufacturing, and Controls (CMC) and Good Manufacturing Practices (GMPs):The Big Picture of a Long-term Commitment"

https://www.google.com/url?sa=t&rct=j&q=&esrc=s&source=web&cd=2&cad=rja&uact=8&ved=0ahUKEwjupcqs-eDUAhVr0oMKHbLpDuoQFggtMAE&url=https%3A%2F%2Fwww.accessdata.fda.gov%2Fstatic%2Fcvm%2Fcormier%2FCMCsandGMPs.pptx&usg=AFQjCNFsvY01ZQsTLQt37HBT-oBzdPi0Jw

Link downloads a short powerpoint.

"A manufacturing process under control exhibits consistency of product quality"

This is what has to be done, for any size batch, to say that scale up has been completed for that level of production, whether 200 gm or 1 kg or more.

Is NNVC there at any level? Does all this CMC work need to be done before clinical trials can be approved in Australia?

See also: https://www.fda.gov/drugs/guidancecomplianceregulatoryinformation/guidances/ucm064979.htm