ABSTRACT

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

chapter 1|8 pages

Introduction

chapter 2|16 pages

Regulations, Standards, and Guidelines

chapter 3|12 pages

Terminology and Validation Overview

chapter 4|18 pages

Risk-Based Validation and Qualification

chapter 6|8 pages

Design Qualification

chapter 7|10 pages

Installation Qualification

chapter 8|12 pages

Operational Qualification

chapter 9|16 pages

Performance Qualification and Maintenance

chapter 11|30 pages

Validation of Analytical Methods

chapter 13|14 pages

Handling Out-of-Specification Situations

chapter 14|10 pages

(Certified) Reference Standards

chapter 15|20 pages

People

chapter 17|14 pages

Audits