The Global Guideline for GCP Audit and Appendices
Tsuyoshi Kurose 1, Eric Humes2, Glene Sandom3
1Japan Society of Quality Assurance, Tokyo, Japan, 2Society of Quality Assurance, Charlottesville, USA, 3Research Quality Association, Ipswich, UK
The Society of Quality Assurance (SQA), Research Quality Association (RQA) and Japan Society of Quality Assurance (JSQA) have reached an agreement on the Global Guideline for GCP Audit (hereinafter referred to as the GUIDELINE). The GUIDELINE has been published in the Quasar Publication and the websites of each organization. Moreover, because the GUIDELINE stipulates only the basic principles of GCP audits, the three organizations made a decision to prepare appendices to the GUIDELINE. These supplemental documents are intended to be used together with the GUIDELINE and are provided only as an example for GCP audits. Thus, these appendices to the GUIDELINE were discussed and approved by SQA, RQA and JSQA on the assumption that the contents of these appendices may be substituted, modified or supplemented by users.
An overview of the GUIDELINE and appendices will be given prior to the panel discussion.