Advancing microbiology QC in biomanufacturing requires new technologies, strong cross-functional practices, and collaboration ...

Advanced biologics and patient-specific therapies reduce opportunities for terminal sterilization, elevating proactive microbial risk control and integrating QC microbiology into CCS authorship, risk ...

The mass production of pharmaceuticals has significantly evolved since the industrial fabrication of synthetic drugs towards the end of the 19 th century 1 with efficient developments in process ...

A Contamination Control Strategy (CCS) outlines a means of identifying and analyzing risk, reviewing mitigating innovations and opportunities, and ultimately defining preventive and corrective action ...

Aseptic gowning procedures play an important role in supporting contamination control strategies across pharmaceutical and cleanroom environments.

One of the main goals of pharmaceutical regulatory rules is to keep environmental contamination at a minimum. According to the EU GMP Annex 1 regulatory standard for sterile drug products, a ...