Jim Agalloco, Russ Madsen and Jim Akers developed a comprehensive set of comments to the draft revision of Annex 1. The authors believe it is essential that the EMA receive comments that outline the difficulties that the draft presents. Their more than 170 comments cover the entire document and detail its many shortcomings. Feel free […]
Many aspects need to be considered in setting up a cleaning procedure. This is certainly a mul-tidisciplinary issue that involves various company areas: from “Regulations” to Engineering, from Quality Control lab to Production department. Contributions of all these areas together can lead to a robust and re-producible cleaning process.
An increasing interest in continued process verification has brought to the spread of on-line assay methods in cleaning processes . This paper deals with two different on-line applications: conductivity sampling and the Total Organic Carbon analysis for washing machines.