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Book

Validation of Pharmaceutical Processes

Book

Validation of Pharmaceutical Processes

DOI link for Validation of Pharmaceutical Processes

Validation of Pharmaceutical Processes book

Validation of Pharmaceutical Processes

DOI link for Validation of Pharmaceutical Processes

Validation of Pharmaceutical Processes book

Edited ByJames P. Agalloco, Frederick J. Carleton
Edition 3rd Edition
First Published 2008
eBook Published 8 February 2013
Pub. Location Boca Raton
Imprint CRC Press
DOI https://doi.org/10.3109/9781420019797
Pages 760
eBook ISBN 9780429113963
Subjects Bioscience, Engineering & Technology
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Agalloco, J.P., & Carleton, F.J. (Eds.). (2008). Validation of Pharmaceutical Processes (3rd ed.). CRC Press. https://doi.org/10.3109/9781420019797

ABSTRACT

Completely revised and updated to reflect the significant advances in pharmaceutical production and regulatory expectations, this third edition of Validation of Pharmaceutical Processes examines and blueprints every step of the validation process needed to remain compliant and competitive. The many chapters added to the prior compilation examine va

TABLE OF CONTENTS

chapter 1|4 pages

Why Validation?

chapter 2|6 pages

Organizing for Validation

chapter 3|16 pages

Validation and Facility Design

chapter 4|24 pages

Validation of Environmental Control Systems Used in Parenteral Facilities

chapter 5|8 pages

Validation of Critical Utilities

chapter 6|40 pages

The Validation of Pharmaceutical Water Systems

chapter 7|10 pages

Calibration and Metrology

chapter 8|20 pages

Temperature Measurements

chapter 9|18 pages

Qualification and Change Control

chapter 10|12 pages

Microbiology of Sterilization Processes

chapter 11|16 pages

F, D, and z Values

chapter 12|12 pages

Steam Sterilization in Autoclaves

chapter 13|14 pages

Validation of Terminal Sterilization

chapter 14|22 pages

Steam Sterilization-in-Place Technology and Validation

chapter 15|18 pages

Dry Heat Sterilization and Depyrogenation Validation and Monitoring

chapter 16|22 pages

Validation of Ethylene Oxide Sterilization Processes

chapter 17|6 pages

Validation of Chlorine Dioxide Sterilization

chapter 18|8 pages

Validation of the Radiation Sterilization of Pharmaceuticals

chapter 19|10 pages

Isolator Decontamination

chapter 20|16 pages

Validation of Sterilizing-Grade Filters

chapter 21|14 pages

Cleaning and Disinfection in the Control of Pharmaceutical Cleanrooms

chapter 22|10 pages

Aseptic Processing for Dosage Form Manufacture: Organization and Validation

chapter 23|6 pages

Validation of Aseptic Processing for Bulk Pharmaceutical Chemicals

chapter 24|6 pages

Validation of Manual Aseptic Processes

chapter 25|18 pages

Monitoring of Nonviable Particles

chapter 26|14 pages

Viable Environmental Microbiological Monitoring

chapter 27|10 pages

Validation of Container Preparation Processes

chapter 28|18 pages

Validation of Lyophilization

chapter 29|4 pages

Qualification Concerns for Isolator Systems

chapter 30|14 pages

Validation of Solid Dosage Finished Goods

chapter 31|12 pages

Validation of Oral/Topical Liquids and Semisolids

chapter 32|14 pages

Validation of Packaging Operations

chapter 33|12 pages

Validation of Bulk Pharmaceutical Chemicals

chapter 34|18 pages

Validation of Recovery and Purification Processes

chapter 35|8 pages

Validation of Process Chromatography

chapter 36|10 pages

Cell Culture Process Validation

chapter 37|28 pages

Cleaning Validation for the Pharmaceutical, Biopharmaceutical, Cosmetic, Nutraceutical, Medical Device, and Diagnostic Industries

chapter 38|10 pages

Validation of Training

chapter 39|20 pages

Vendor Qualification and Validation

chapter 41|6 pages

Validation of New Products

chapter 42|10 pages

Retrospective Validation

chapter 43|6 pages

Validation and Six Sigma

chapter 44|12 pages

Validation and Contract Manufacturing

chapter 45|24 pages

Process Analytical Technology and Validation

chapter 46|12 pages

Computerized Systems Validation

chapter 47|10 pages

Validation of Control Systems

chapter 48|12 pages

Risk-Based Validation of a Laboratory Information Management System

chapter 49|14 pages

Validation of Laboratory Information Systems

chapter 50|10 pages

Validation of Analytical Procedures and Physical Methods

chapter 51|6 pages

Validation of Microbiological Methods

chapter 52|6 pages

Implementation of Validation in the United States

chapter 53|6 pages

The European Approach to Validation—A Microbiological Perspective

chapter 54|12 pages

Japanese Regulatory Requirements

chapter 55|8 pages

Managing Validation in a Multinational Company

chapter 56|6 pages

Validation in a Small Pharmaceutical Company

chapter 57|6 pages

Regulatory Aspects of Validation

chapter 58|4 pages

Validation—What’s Next?

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