Reconsideration: Non-Sterile Drug Manufacture – Don’t Let It Bug You!

The bulk of microbiology attention in the drug manufacturing world is laser focused on sterile drug products and the myriad steps needed to aseptically manufacture them. That is certainly with good reason as those drug products carry the highest patient risk should there be microbial contamination. One aseptic manufacturing misstep and the consequences could be […]

Read More

Establishing a CCS Foundation for Cleaning Validation 

Bring up the recently updated and finalized EU Annex 1 – Manufacture of Sterile Medicinal Drug Products (here) in polite pharmaceutical water cooler conversation and a frequent topic that comes up is the Contamination Control Strategy (CCS) language.  Buzzwords abound for a “holistic”, “global”, or “wholesale” CCS to be incorporated into all elements of aseptic […]

Read More