A Practical Guide to GLP Quality Assurance

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UK GLP Regulations and OECD GLP Principles define the requirements of a testing facility with respect to the performance of GLP studies but give little/no practical guidance for personnel working in the analytical laboratory. This document aims to provide useful guidance for laboratory personnel, but should not be relied upon absolutely since it is not possible to consider and address the entire variety of analyses performed in a laboratory environment.

This publication provides guidance to Management on the application of GLP Principles in all laboratories undertaking analytical procedures.  Further guidance for Management can be found in the RQA publication: A Guide to the Roles and Responsibilities of GLP Management.  It also aims to provide guidance to laboratory staff in the organisation and conduct of their work in order to ensure compliance with GLP principles.

Contents

1. Introduction
2. Management
3. Laboratory Personnel
4. Study Director and/or Principal Investigator
5. Quality Assurance
6. Facilities
7. Equipment
8. Standard Operating Procedures (SOPs)
9. Study Plan
10. Laboratory Procedures
11. Investigation of Unexpected or Atypical Results
12. Data Integrity
13. Reporting of Results
14. Archives

ISBN

1-904610-35-9

Published

August 2016

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