Focus on Environmental Monitoring vs. ANNEX 1

DATE

18 May 2020
(Duration : 60 mins)

SPEAKERS

Gilberto DALMASO,
Pharma and Medical Devices Consulting Owner at GDM Pharma Consulting

Arnaud PARIS,
bioMérieux Industry EMEA Healthcare Scientific Affairs Director

WEBINAR OVERVIEW

Viable and non-viable environmental and process monitoring:

The guidance here applies to ongoing routine monitoring with regards to the design of systems and setting of action limits alert levels and reviewing trend data. The section also gives guidance on the requirements of Aseptic Process Simulation (APS).

-    Risk assessments should be performed in order to establish a comprehensive environmental monitoring program
-    Monitoring procedures should define the approach to trending

NON VIABLE Environmental Monitoring (total particles)

VIABLE Environmental Monitoring (microbiological monitoring)
-    PASSIVE AIR MONITORING 
-    ACTIVE AIR MONITORING 

Impact of the Annex 1 on Environmental Monitoring

-    Contamination Control Strategy – CCS
-    Scientifically sound method
-    Justification
-    Potentially more sampling points
-    Potentially more identifications
-    Opens the door to Automation and Rapid Methods