Guide to the Role and Responsibilities of GLP Management

Please select your desired format:

• Hard Copy
• eBook (plus VAT where applicable)

Please note: payment is required before the ebooklet is sent via email.  However if you need earlier access please contact publications@therqa.com.

VAT on Electronic Books is chargeable in the UK and EU. Please see the 'Booklet Terms and Conditions' for further details.

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

---

Recommended Products

Booklets

A Practical Guide for the Good Laboratory Practice Study Director
A Practical Guide to Good Laboratory Practice in the Analytical Laboratory
Good Clinical Laboratory Practice (GCLP)
Hosting an External GLP Inspection
Management of the Training and Competency of Personnel in GxP and Research Environments

Courses

P04 Quality Assurance for Good Laboratory Practice
P05 Good Laboratory Practice for Study Directors, Principal Investigators, Study Staff and Management
RP04 Quality Assurance for Good Laboratory Practice REMOTE LEARNING
RP05 Good Laboratory Practice for Study Directors, Principal Investigators, Study Staff and Management REMOTE LEARNING
RP16 Good Laboratory Practice Refresher and Hot Topics REMOTE LEARNING

eLearning Products

Advanced Good Laboratory Practice (GLP) elearning
Introduction to Good Clinical Laboratory Practice (GCLP) elearning
Introduction to Good Laboratory Practice (GLP) elearning
Introduction to Quality Risk Management (QRM) elearning
Introduction to the Audit Process elearning