Article | December 26, 2018

Microbiology Fulfills A Vital QC Role At A CDMO In Aseptic Filling And Sampling

Source: Singota Solutions

By Summer Wade

Lab laptop scientist 450x300

When a pharmaceutical company is looking to outsource manufacturing, analytical testing, packaging, or supply chain functions to a CDMO, they come in with a long list of testing requirements, manufacturing specifications, timetables, pricing, and other business concerns. In the background, though, is the fundamental requirement that the CDMO maintains an operating environment sufficiently controlled to formulate, manufacture, test, package, store, and ship drugs that will be for human use.

Microbiological contamination is at the top of the CDMO threat list and controlling it is the responsibility of trained, professional microbiologists.