The MHRA GLP guidance document on the content of GLP quality assurance statements has been revised.


During routine GLP compliance monitoring inspections, GLP inspectors will review completed regulatory studies. During the review of these studies, inspectors occasionally encounter issues relating to the information contained within the quality assurance Statement. The purpose of this note is to provide guidance on current GLPMA expectations for the content of Quality Assurance Statements.


Posted on the UK MHRA website on 17 July 2013