SARS-CoV-2 Injection Manufacturers ALL Broke the Rules on Patient Safety

Products made for clinical trials

What are the Rules?

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:

PHARMACEUTICAL SUPPLY CHAINS IN THE NEWS, FOR THE WRONG REASONS

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 were Tightened

In the EU, major changes were also made to Good Distribution Practice (GDP) and Good Manufacturing Practice (GMP).

This was to protect patients further, by placing obligations on companies manufacturing medicines to trace right back to the upstream sources of all materials used, to ensure they were genuine. The obligations also required traceability records to be kept, and audits carried out to ensure those companies were working to the regulations.

Legislation did not go far Enough

Unfortunately, as the legislation passed (for a number of reasons we can’t go into here) it only applied, and still does, to finished products as they travel from the finished product manufacturer to wholesalers and pharmacies.

Prevention of upstream adulteration, as per heparin, is dependent on manufacturers complying with the GDP and GMP.

Trust me, they could never have done that!

The thing to remember is that Good Manufacturing Practice (cGMP) applies to clinical trials, as well as commercial supply. It would have to, wouldn’t it, as the drugs are being tested on humans.

I would have more chance of climbing Everest naked (not a pretty sight!) than the manufacturers would have had in securing full traceability AND applying the GMP rules for clinical trial supplies.

Something for medical freedom fighters to ponder, questions welcome :)

Hedley