Real-Time Microbial Monitoring: Maintaining the quality of Purified Water and Water for Injection

摘要

Changes in regulations, expiring patents, and growing competition are placing ever-growing pressures on pharmaceutical companies. These stresses are resulting in an increasing focus from drug manufacturers and regulators on how modern production methodologies can be applied in the production of pharmaceuticals that will enable greater efficiencies alongside improving product safety. The FDA's Process Analytical Technology (PAT) initiative, EMA Guidance on Real Time Release, ICH Guidelines Q 8-10, etc., all offer approaches to raising production efficiency for even the most conservative drug company. It is not surprising, then, that there has been growing adoption of continuous analytical technologies that can rapidly identify out-of-specification conditions and lessen the workload burden on laboratories.