GMP Audits in Pharmaceutical and Biotechnology Industries
Series: Drugs and the Pharmaceutical Sciences;
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Product details:
- Edition number 1
- Publisher CRC Press
- Date of Publication 28 June 2024
- ISBN 9781032257303
- Binding Hardback
- No. of pages560 pages
- Size 254x178 mm
- Weight 1120 g
- Language English
- Illustrations 52 Illustrations, black & white; 2 Illustrations, color; 2 Halftones, color; 52 Line drawings, black & white; 133 Tables, black & white 574
Categories
Short description:
This user-friendly volume presents a basic knowledge on how to perform an audit or inspect a facility and meets all the needs of the audience. It is a key reference source for those training as auditors in organizations that follow FDA, EMA, MHRA, WHO, TGA, PIC/S regulations.
MoreLong description:
The fact that good manufacturing practice (GMP) audits in the pharmaceutical and biotechnology industries have to be evaluated, and with very limited resources, has created a gap in this field. The lack of trained and qualified GMP auditors is on the rise in all organizations that are required to implement FDA, EMA, MHRA, WHO, TGA, and PIC/S regulations. This volume is an essential reference source for those organizations operating in the field of health and presents the basic knowledge needed to perform audits. The author also provides useful tips and a selection of samples about GMP audits that are indispensable for professionals and health inspectors working in industry and health authorities.
Features
- An essential reference source for those organizations operating in the field of health and presents the basic knowledge needed to perform audits
- Anyone working in the manufacturing sector needs to be aware of GMP, be able to identify operational flaws as well as legal violations, and have a clear understanding of how to meet GMP standards
- Assists readers in understanding the importance of GMP and how they can apply each aspect in their working environment
- Covers a global regulatory landscape
- Suitable for relevant degree courses including industrial pharmaceutics and pharmaceutical biotechnology
Table of Contents:
Dedication
Preface
Author Biography
Abbreviation
Chapter 1 - The Concept of Quality
Chapter 2 - GMP Audits
Chapter 3 - GMP Auditing in Various Areas
Chapter 4 - Auditing Pharmaceutical Quality Management System
Chapter 5 - Alternative Auditing Methods
Chapter 6 - Audit Question Examples
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