NanoViricides Inc. (NNVC)

[robi-1-kenobi]

No, still not correct: GMP=cGMP. cGMP is the generally accepted usage, not GMP. Although GLP is generally accepted usage, not cGLP.

Bloomvest quote:

Notice I wrote "per GMP" I agree cGMP is not required.

Robi-1 quote:

P.S. You are also incorrect that the materials "need to be produced in the new facility per GMP".
The regulations are clear that cGMP is not required for Regulatory GLP Toxicity studies, although it is recommended.

The "c" in cGMP stands for current Good Manufacturing Practices, not certification if that is what you were thinking. cGMP = GMP as far as FDA and industry is concerned. No difference. Companies must abide by the regulations per 21 CFR regarding GMP - AND must stay current to new best practices in industry. It is not enough to just follow the regulations only.

And neither cGMP nor GMP nor cGMP-like nor GMP-like are required for Regulatory GLP Toxicity studies. If you doubt it, read the 21 CFR Part 58 regulations for GLP at the following link. Run a search on "cGMP", "GMP" and "Good Manufacturing Practices" with and without "current". You will not find them.

LINK:http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRsearch.cfm?CFRPart=58

There are numerous industry white papers that state cGMP and cGMP-like are recommended but not required for Regulatory GLP Toxicity studies. One at the following link:

LINK:IND Development Plan white paper

There is one exception. As BK stated, oncology Regulatory GLP Tox studies do require cGMP materials due to the usually toxic nature of anti-neoplastic agents.