The neglected child in vax safety, now long forgotten—chemistry, manufacturing & controls.
Dangerous or what?!
What is chemistry, manufacturing & controls (CMC)
CMC is one of three data modules that must be submitted to a regulatory authority as part of the approval process to market a prescription medicine (drug).
The other modules are safety and clinical. The modules are identified as follows;
Module 3 - chemistry, manufacturing & controls (CMC)
Module 4 - safety
Module 5 - clinical
These data must be submitted in what is known as the eCommon Technical Document (eCTD). This document is harmonized globally, so that every regulatory body has a common process:
You can see the three modules along the bottom of the triangle, and these can be regarded as the foundational data, in terms of studies and reports that the summaries above depend on. Note the opportunity for confusion here, as Module 3 has been shortened to ‘Chemistry’, and the summary is titled ‘Quality’.
For clarity, Module 3 relates to the entire supply chain, from beginning to end. It starts with raw materials and ends with a finished produc…