This guideline presents a discussion of elements for consideration during the validation of analytical procedures included as part of registration applications submitted within the ICH member regulatory authorities. It provides guidance and recommendations on how to derive and evaluate the various validation tests for each analytical procedureand serves as a collection of terms, and their definitions. This guideline applies to new or revised analytical procedures used for release and stabilit...| European Medicines Agency (EMA)
The first independent testing of Australian vials confirms findings from the US, Canada and Germany, highlighting that oncogenic and genomic integration risks are a global concern| news.rebekahbarnett.com.au
DNA impurities can impact the safety of genetically engineered pharmaceuticals; thus, a specific limit value must be set for them during marketing authorisation. This particularly applies to mRNA vaccines, as large quantities of DNA templates are used for their production. Furthermore, when quantifying the total DNA content in the final product, we must observe that, in addition to the mRNA active ingredient, DNA impurities are also encased in lipid nanoparticles and are therefore difficult t...| MDPI
At least four independent labs around the world claim to have detected excessive levels of plasmid DNA in the mRNA Covid vaccines| news.rebekahbarnett.com.au
AMPS presents two crucial inquiries to the Australian Federal Court: Are Covid-19 drugs classified as GMOs? If so, has the law been violated by Pfizer and Moderna?| amps.redunion.com.au
