The Global Guideline for GCP Audit

Background

ICH GCP has been adopted by three regions and implemented since 1996. The details on GCP auditing are not provided in ICH GCP and there is no global guideline for GCP audit. JSQA thought that the global guideline for GCP audit was necessary to harmonize GCP auditing for the quality assurance of global clinical studies. JSQA looked at ENGAGE (The European Forum for Good Clinical Practice) Auditing Guideline (1998 and 2005), ICH Proposed Guideline for GCP compliance and Quality
System Auditing (1993), ISO 9000 Quality management systems-Fundamentals and vocabulary (2000), ISO 19011 Guidelines for quality and/or environmental management auditing (2002), etc. to get the benefits of them.
JSQA completed the “JSQA Guideline for GCP Auditing” and announced it at 1st GQAC in 2005 as a poster session.
JSQA published “JSQA Guideline for GCP Auditing” on QA Journal of SQA in 2007 (QAJ 403) in order to promote the global discussion for the harmonization of GCP audit.
JSQA proposed the global discussion for Global Guideline for GCP Audit among SQA, BARQA and JSQA in November 2007 at the BARQA annual conference. The global project members were identified and had the kick-off meeting in April 2008 at the 24th SQA annual meeting. The global project members had meetings in October 2008 at 2nd GQAC in Edinburgh and in April 2009 at the 25th SQA annual meeting to discuss the guideline.

This guideline was completed based on the global discussions among SQA, BARQA and JSQA. The guideline includes the mission and the organization of a sponsor’s auditing department and establishes 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.

Table of Contents
1 Scope of the Guideline
2 Definitions

3 Mission of a Sponsor’s Auditing Department
4 Auditing Department
4.1 Independent Auditing Department
4.2 Qualified Auditors
4.3 Qualifications of Auditors
4.4 Responsibilities of Auditors

5 Planning of Audits
5.1 Establishing the Goals of an Audit
5.2 Designing and Updating the Audit Plan
5.3 Determining the Subject(s), Timing, and Method(s) of an Audit
5.4 Information in the Audit Plan

6 Conduct of an Audit
6.1 Explaining the Auditing Procedures
6.2 Conducting an Audit and Collecting information
6.3 Confirmation and Evaluation of Audit Observations

7 Reporting the Results of an Audit
7.1 Preparation of an Audit Report
7.2 Persons to whom Audit Reports are submitted

8 Corrective and Preventive Actions
9 Completion of an Audit
10 Audit Certificate

11 Keeping Audit Records

Author: JSQA:
Hiroyasu Yamashita.
Reviewed and Acknowledged by:
BARQA:
Patricia Fitzgerald
SQA:
MaryEllen Lander