Microbial, particulate and pyrogen contamination ever present in SARS-CoV-2 jabs

MHRA/EMA/FDA must physically inspect the contract manufacturing organizations

Expert witness statements on SARS-CoV-2 contamination

To help you get a better handle on the time and complexity involved in keeping supply chains safe, this is something on the dangers of contamination that has been submitted in an expert witness statement. This is what FDA requires a manufacturer to do in the event of a contamination finding:

1.      A company involved in the manufacture of prescription drugs (drugs) must adhere to CGMP regulations, defined in the US Code of Federal Regulations, Title 21.

2.      The relevant sections applicable to drugs manufactured by chemical synthesis (small molecule) are 21 CFR PART 210 - CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PROCESSING, PACKING, OR HOLDING OF DRUGS; GENERAL and PART 211 - CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS

3.      The SARS-CoV-2 injections are categorized as biological products, and in addition to 21 CFR PART 210/211, are also governed by 21 CFR PART 600 - BIOLOGICAL PRODUCTS: GENERAL where biological products are defined as:

“Biological product means a virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, protein, or analogous product, or arsphenamine or derivative of arsphenamine (or any other trivalent organic arsenic compound), applicable to the prevention, treatment, or cure of a disease or condition of human beings.”

4.      Biological products are far more susceptible to quality issues