Designed to enable readers to plan and execute their own audits, this comprehensive guide presents both discussions and practical applications related to establishing a GLP QA unit and performing effective GLP audits. The first section provides the foundation of information needed for designing and initiating a Good Laboratory Practice quality assurance program. Section II contains ready-to-use audit checklists and regulatory references that are in accordance with the most recent regulations. Section III illustrates with examples the document requirements of the Quality Assurance Unit and provides a clear understanding of its function. Section IV comprises the full texts of the relevant standards and regulations along with the Principles of Good Laboratory Practice.
| ISBN: | 9780367398439 |
| Publication date: | 27th May 2020 |
| Author: | Milton A. Anderson |
| Publisher: | CRC Press an imprint of Taylor & Francis Ltd |
| Format: | Paperback |
| Pagination: | 464 pages |
| Genres: |
Pharmaceutical chemistry and technology |