PharmaCyte Biotech Inc (PMCB)

[PINKribbon]

R E A D IT!
R E A D IT!
R E A D IT!

cGMP Validation is playing a pivotal role for PharmaCyte and will continue to
do so as it moves forward with the preparation of its IND. The role of cGMP
Validation and its President and Chief Executive Officer, Jesse Gillikin, in
particular, is to ensure that each and every step of the manufacturing process
of PharmaCyte’s encapsulated cells completely complies with the FDA’s cGMP
regulations and all other FDA requirements requested by the U.S. drug
regulatory agency. In addition to ensuring that PharmaCyte’s clinical trial
product meets regulatory compliance throughout the production process, cGMP
Validation will also serve as a resource to Austrianova in its manufacturing
process related to cGMP requirements with which it must adhere. For example,
cGMP Validation will examine cGMP required documents prepared by Austrianova
that concern all “production runs” of the manufacturing process and work with
Austrianova to ensure compliance in every respect.

cGMP Validation will also serve, on behalf of PharmaCyte, as the agent for the
“release” of the final product that will be implanted into patients before the
chemotherapy prodrug ifosfamide is given during the planned clinical trial in
LAPC.

One PR was about the work during the manufacturing process, and the latest PR was about compliance work needed for importing...POST PRODUCTION!!!