Haider, Syed Imtiaz. Validation standard operating procedures: a step-by-step guide for achieving compliance in the pharmaceutical, medical device, and biotech industries

Validation standard operating procedures are written to provide explicit instruction on how to achieve the standards for those responsible for writing and executing master validation plans for drug, drug-device combination, diagnostic, pharmaceutical biotechnology, and bulk pharmaceutical chemicals products. Included is the ready-to-use template so that one can immediately save time and
expense without missing any critical elements.
The book provides instant answers to validation engineers, validation specialists, quality professionals, quality assurance auditors, and protocol writers about what to include in validation standard operating procedures and how to enhance productivity.
Introduction

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The book are designed for individuals specifically involved in writing and execution of master validation plans, development of protocols, and applicable procedures. This book provides a complete, single-source reference detailing conceptual design elements and more than 70 explicit procedures for validation.

Validation of Pharmaceutical Processes. Third Edition. Edited by James Agalloco, Frederick J. Carleton

With the goal of ensuring pharmaceutical quality of the final manufactured product, the editors have introduced to the industry as object so extensive that it impacts on good manufacturing practices, research and development, quality assurance,and facility design. Validation inevitably leads to process optimization, Increased productivity, and lower costs in man-time and manufacturing. The objective of the third edition is to encompass the changes that have taken place in the pharmaceutical industry during the past several years.
Contents
Preface v
SECTION I. INTRODUCTION
SECTION II. SUPPORT AND UTILITY SYSTEMS
SECTION III. STERILIZATION, SANITIZATION, AND STERILITY ASSURANCE
SECTION IV. STERILE PRODUCT MANUFACTURING
SECTION V. SECONDARY MANUFACTURING
SECTION VI. PRIMARY MANUFACTURING
SECTION VII. MANUFACTURING RELATED ACTIVITIES
SECTION VIII. COMPUTERIZED SYSTEMS
SECTION IX. LABORATORY METHODS AND QUALITY ASSURANCE
SECTION X. GENERAL TOPICS