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
Clinical Research News
다가오는 임상 시험
-
NCT05893524모병백치 | 가벼운 인지 장애 | 치매, 혼합 | 알츠하이머형 치매 | 주관적 인지 장애 | 치매 노인성
-
NCT05895136아직 모집하지 않음
-
NCT05895201아직 모집하지 않음급성 골수성 백혈병 | 골수이형성 증후군 | 만성골수단구성백혈병 | 급성 림프구성 백혈병, 성인 | 골수 이식 합병증
-
NCT05895344아직 모집하지 않음해면정맥동 수막종 | 양성자 요법 | 광자 방사선 요법 | 인지 및 기능적 영향
Clinical Research Jobs
-
Project Support Coord
-
Sr Project Support Coord
-
Senior Clinical Project Manager - FSP
-
Study Start Up Specialist (FSP)
-
Clinical Trial Coordinator - R
-
Project Specialist level I and II
-
Associate Director, Regulatory Submissions
-
Experienced Site Payments Analyst
-
Associate Director, Account Management
-
Site Payments Manager
-
Budget & Contract Manager
-
Budget & Contract Analyst