Guide to the Role and Responsibilities of GLP Management eBooklet

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This guidance booklet has been produced by a group of members from the RQA Good Laboratory Practice (GLP) Committee. The group was chaired by John McRoberts (sanofi-aventis), and included Mark Goodwin (GlaxoSmithKline), Jane Shackleton (York Bioanalytical Solutions) and Sue Gledhill (formerly AstraZeneca).

The RQA GLP Committee identified a gap in available guidance around the role and responsibilities of test facility management. It was considered that management, whether new to the role or well established, would welcome further interpretation of their GLP responsibilities. The group set its objective to produce a booklet that provided additional explanation and practical options for management to meet their GLP obligations.

Contents

1. Introduction
2. Who is Management
3. Integrating GLP into the Business
4. Maintaining a GLP Compliant Facility
5. Responsibilities Test Facility Management
6. Corrective Action and Preventive Action
7. Role of Management During Regulatory Inspections
8. Use of Non-GLP Facilities
9. Notification of Changes at a Test Facility
10. Legal Matters

Authors

RQA GLP Committee

ISBN

978-1-904610-19-9

Published

First Published October 2009, this edition reviewed January 2013