The JSQA guideline for GCP auditing

Abstract

The International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) has been adopted by three regions USA, Europe and Japan and implemented since 1996. Details of GCP auditing are not provided in ICH GCP. The Japan Society of Quality Assurance (JSQA) has prepared ‘The JSQA GCP Guideline for GCP Auditing’ to promote the global discussion on GCP auditing and expects to establish a global guideline on GCP auditing along with ICH GCP. The guideline will include the mission and the organization of a sponsor's auditing department and establish the principles for planning, performing, and reporting audits. The guideline is expected to be a basic principle along with ICH GCP for not only sponsor's auditors, but also independent auditors and auditors of Contract Research Organizations (CROs) to conduct an audit in the various situations of each country and sponsor. Copyright © 2007 John Wiley & Sons, Ltd.