How to validate your online monitoring system

摘要

Following on from the guide to designing a cleanroom monitoring system, published in the September issue of Cleanroom Technology, this article is set up to cover the critical aspects involved in the installation of a monitoring system under the validation steps as per the guidelines of the ISPE GAMP5. GAMP is an acronym for Good Automated Manufacturing Practice, and it is both a technical subcommittee of the International Society for Pharmaceutical Engineering (ISPE) and a set of guidelines for manufacturers