Overview

This Second Edition discusses ways to improve pharmaceutical product quality while achieving compliance with global regulatory standards. With comprehensive step-by-step instructions, practical recommendations, standard operating procedures (SOPs), checklists, templates, and graphics for easy incorporation in a laboratory. This title serves as a complete source to the subject, and explains how to develop and implement a validation strategy for routine, non-routine, and standard analytical methods, covering the entire equipment, hardware, and software qualification process. It also provides guidance on qualification of certified standards, in-house reference materials, and people qualification, as well as internal and third party laboratory audits and inspections.

Full Product Details

9780849382673

Table of Contents

Reviews

a great single reference containing all you ever wanted to know about validating and verifying assay or equipment performance. Doody's Review - Valerie L. Ng, PhD, MD

a great single reference containing all you ever wanted to know about validating and verifying assay or equipment performance. Doody's Review - Valerie L. Ng, PhD, MD

Author Information

Ludwig Huber

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