Real-time contamination risk-management in drug product moves a step closer
Subject matter experts from Environmental Monitoring (EM) and Rapid Micro Methods (ARRM) workstreams are on track to fulfil an ambitious vision: to deliver real-time EM in modern drug product facilities.
Discussing how this vision can be brought to life, the group met in Chicago recently to review replacing traditional methods of monitoring with modern techniques. The group believes that in the next two to three years, most modern facilities can have:
-Harmonized EM programs with the right amount of monitoring which auditors will fully trust
-Realtime intervention-free trending data Grade A environments enabling better process control
-Investigations of any suspected EM excursions carried out in a fraction of the current time and getting to the actual root cause.
The EM team is finalizing a harmonized risk-based EM toolkit to identify the locations with higher contamination risk and associated sampling schemes. Expect to see publications in 2017 and implementation pilots run in most member companies in Q1 2018. The ARMM team has already submitted for internal technical review a paper with a strong case for replacing traditional monitoring in Grade A with bio-fluorescent particle counters (BFPC). Early feedback on this Grade A argument from key agency opinion leaders is positive. A paper on the use of BFPCs for investigations is also being drafted for publication early in 2018. In the paper are several compelling examples of the proven value of BFPCs – for quality and economic benefit.
If you would like to find out more, contact Dawood at Dawood@biophorum.com.