The Pharmaceutical Supply Chain for Safety Testing—How did the Jabs get it done so quickly?
Cutting corners?
The Pharmaceutical Supply Chain for Safety Testing
In this post below, AlisonW commented on the various supply chain ‘irregularities’ that have now become apparent in the pharmaceutical supply chain, especially in relation to SARS-CoV-2 injections:
This prompted me to say more about the practicalities of safety testing in the pharmaceutical supply chain. Here we go:
Drug Development Regulations and the Supply Chain
The program of development is dictated by regulatory rules and guidance. A prospective Clinical Trial Sponsor (CTS) has total responsibility for every aspect of the supply chain being put in place. One or more companies may be producing at each stage (raw materials, starting materials, drug substance, drug product, finished product), depending on the supply chain strategy envisaged by the prospective CTS.
Sufficient Drug Substance (DS) will be produced to satisfy the needs of in vitro (test tube) and in vivo (animal) testing. The vast majority is used for in vivo testing in animal models. There is no requirement for the compound to be in any dosage form at this stage.
Sufficient safety data that will subsequently be included in Module 3 and Module 4 of the Electronic Common Technical Document (eCTD) must be collected and analyzed by the prospective CTS. Typically, the data are collected from the contract development and manufacturing organizations (CDMO(s)) and contract research organizations (CRO(s)) carrying out production and testing.
If the prospective CTS considers the data can support an application to embark on trials in humans