Maria Gutschi, PharmD, on Lack of Manufacturing Quality of mRNA Injections
mRNA/DNA injections cannot be manufactured to cGMP standards.
Maria is a pharmacist and a regulatory specialist from Canada. She has thoroughly reviewed Pfizer's manufacturing documents from EMA and FDA Chemistry and Manufacturing Controls sections and identified glaring and still unsolved (and unsolvable) problems. The product should be considered fraudulent and adulterated. No verification or assurance of the product composition per dose, as described on the “approved” label can be made. The quality/product assurance tests described in Pfizer's documents only apply to batches (bulk product in a vat) and do not specify any product conformity tests at the dose level (as administered). This is a glaring violation of existing regulations for pharmaceutical products.
It is my personal but highly educated opinion that these toxic concoctions cannot be made to cGMP. Numerous failed attempts to put these products on the market as normally regulated pharmaceuticals failed continuously for the past 20+ years. They only succeeded under a scam “pandemic” as DoD manufactured “prototypes” with billions spent on fearmongering propaganda and purchasing every available prostitute in the US Government, healthcare, academia, Hollywood, sports, and school districts to to playact a “health crisis” and “vaccine development and deployment” horror show.
While the “vaccine” was a scam, a military prototype (aka weapon) disguised as medicine, the deaths and injuries are real and ongoing. More about the scam is in the two posts below below for new readers of this substack: