A Contamination Control Strategy (CCS) identifies and evaluates contamination risks, explores mitigation options, and sets out plans for corrective and preventive actions. Its implementation addresses ...

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

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 comprehensive contamination control strategy must include a dedicated section addressing personnel-related microbiological and particulate contamination risks introduced into an aseptic process, as ...

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 ...