Best Practice for Particle Monitoring in Pharmaceutical Facilities
This NEW Monograph takes a practical, pragmatic approach to particle monitoring. It provides current best system design and operational practices, which fully comply with international good manufacturing practice expectations. It has been created by the PHSS Special Interest Group composed of society members representing major global pharmaceutical, contract and other manufacturing companies, equipment suppliers and other subject matter experts. Contributions and comment have also been received from the UK MHRA.
The Monograph is specific to advice on non-viable particle monitoring systems used in pharmaceutical facilities where compliance to the requirements set forth in the recent (2008) revised EU GMP Annex 1 needs to be demonstrated. It is recognised that non-viable particle counting systems should be part of a facility programme of environmental monitoring measures, including microbiological monitoring (viable particles), temperature monitoring, air flows verification and differential air pressures monitoring.
Cost: € 109.00 plus shipment. Can be orded here