SARS-CoV-2 INJECTION MANUFACTURERS ALL BROKE THE RULES ON PATIENT SAFETY
Why aren't they up before a Judge answering the killer questions here?
WHAT RULES ARE THESE THEN?
In the EU, they are known as Rules and Guidance for Pharmaceutical Manufacturers and Distributors 2017 (The Orange Guide). The equivalent in the US is the Code of Federal Regulations, Title 21, otherwise referred to as 21 CFR.
They have been in place for decades, and have become increasingly stringent as incidents have occurred in the supply chain to threaten the safety of patients. In 2007, one such incident occurred, resulting in death and serious adverse events, see below:
This tragic incident lead to legislation being passed on either side of the pond. In the EU, it was the Falsified Medicines Directive, 2011. In the US it was the Drug Supply Chain Security Act (DSCSA), 2013.
The aim of the legislation was to prevent such an incident ever happening again.
RULES IN THE ORANGE GUIDE WERE TIGHTENED TOO
In the EU, major changes were also made to the Orange Guide, Chapter 5: PRODUCTION.
This was to protect patients further, by placing obligations on companies ma…