Contamination control strategies define risk analysis, mitigation, and corrective actions to support sterility assurance.

Explore key questions on contamination control strategies to support regulatory compliance and risk management in ...

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 ...

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

Review of environmental monitoring updates in the 2022 EU GMP Annex 1, including strategic contamination control.

Correction: This article was edited on 15 September 2022 to correct Jorg Zimmermann's title. Sterile drug manufacturers should start preparing a gap analysis to identify what needs to be done to ...