Can I read Compliance with USP Updates on EtoBox?

Compliance with USP Updates by Salvador Petanas Esteban is a document available to read on EtoBox.

What is Compliance with USP Updates about?

The document summarizes the key changes between the 2008 and 2017 versions of USP <1058> regarding analytical instrument qualification. The 2017 version places more emphasis on risk assessment and user requirements. It requires laboratories to document intended use, perform risk assessments to determine instrument grouping, and be responsible for design qualification. The changes impact laboratory procedures and require reviews and updates to instrument qualifications, SOPs, and policies to ensure complianc

Author

Salvador Petanas Esteban

Language

EN