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CRC Press GMP Audits in Pharma and Biotech Industry Book

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Description

Address the growing shortage of qualified inspectors with this essential reference from CRC Press. As pharmaceutical and biotechnology organizations face increasing pressure to meet FDA, EMA, MHRA, WHO, TGA, and PIC/S regulations, the need for trained GMP auditors has become critical. This volume provides the foundational knowledge necessary to conduct effective audits within the health sector. Designed for organizations operating under strict regulatory oversight, this book helps bridge the gap caused by limited resources and a lack of specialized training. The text offers practical guidance, including useful tips and a selection of audit samples to assist professionals in performing high-quality inspections. It serves as a vital resource for maintaining compliance and improving audit processes in the pharmaceutical sciences.

Key Features

This CRC Press publication provides the basic knowledge required to perform GMP audits in the pharmaceutical and biotechnology industries.

The text addresses regulatory requirements for organizations following FDA, EMA, MHRA, WHO, TGA, and PIC/S standards.

Readers can access practical guidance through useful tips provided by the author to assist in the auditing process.

The volume includes a selection of GMP audit samples to help professionals prepare for real-world inspections.

This book serves as an essential reference source for organizations operating within the health and pharmaceutical sciences fields.

Product Specifications

Format
hardcover
Domain
Amazon UK
Release Date
28 June 2024
Listed Since
27 June 2023

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