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Handbook of Validation in Pharmaceutical Processes

Edited by: James Agalloco , Phil DeSantis , Anthony Grilli , Anthony Pavell

Print publication date:  October  2021
Online publication date:  October  2021

Print ISBN: 9780367754297
eBook ISBN: 9781003163138
Adobe ISBN:

10.1201/9781003163138
 Cite  Marc Record

Book description

Revised to reflect significant advances in pharmaceutical production and regulatory expectations, Handbook of Validation in Pharmaceutical Processes, Fourth Edition examines and blueprints every step of the validation process needed to remain compliant and competitive. This book blends the use of theoretical knowledge with recent technological advancements to achieve applied practical solutions. As the industry's leading source for validation of sterile pharmaceutical processes for more than 10 years, this greatly expanded work is a comprehensive analysis of all the fundamental elements of pharmaceutical and bio-pharmaceutical production processes. Handbook of Validation in Pharmaceutical Processes, Fourth Edition is essential for all global health care manufacturers and pharmaceutical industry professionals.

Key Features:

  • Provides an in-depth discussion of recent advances in sterilization
  • Identifies obstacles that may be encountered at any stage of the validation program, and suggests the newest and most advanced solutions
  • Explores distinctive and specific process steps, and identifies critical process control points to reach acceptable results
  • New chapters include disposable systems, combination products, nano-technology, rapid microbial methods, contamination control in non-sterile products, liquid chemical sterilization, and medical device manufacture

Table of contents

Prelims Download PDF
Chapter  1:  Why Validation? Download PDF
Chapter  2:  Facility Design for Validation Download PDF
Chapter  3:  Modular Facilities—Meeting the Need for Flexibility Download PDF
Chapter  4:  Commissioning and Qualification Download PDF
Chapter  5:  Design and Qualification of Controlled Environments Download PDF
Chapter  6:  Validation of Pharmaceutical Water Systems Download PDF
Chapter  7:  Validation of Critical Utilities Download PDF
Chapter  8:  Calibration and Metrology Download PDF
Chapter  9:  Temperature Measurements Download PDF
Chapter  10:  Change Control Download PDF
Chapter  11:  Microbiology of Sterilization Processes Download PDF
Chapter  12:  Biological Indicators for Sterilization Download PDF
Chapter  13:  Steam Sterilization in Autoclaves Download PDF
Chapter  14:  Validation of Terminal Sterilization Download PDF
Chapter  15:  Steam Sterilization-in-Place Download PDF
Chapter  16:  Validation of Dry Heat Sterilization and Depyrogenation Download PDF
Chapter  17:  Depyrogenation by Inactivation and Removal Download PDF
Chapter  18:  Ethylene Oxide Sterilization Download PDF
Chapter  19:  Validation of Chlorine Dioxide Sterilization Download PDF
Chapter  20:  Liquid Phase Sterilization Download PDF
Chapter  21:  Vapor Phase Sterilization and Decontamination  Download PDF
Chapter  22:  Validation of the Radiation Sterilization of Pharmaceuticals Download PDF
Chapter  23:  Validation of Sterilizing-Grade Filters Download PDF
Chapter  24:  Disinfecting Agents Download PDF
Chapter  25:  Cleaning and Disinfecting Laminar Flow Workstations, Bio Safety Cabinets and Fume Hoods Download PDF
Chapter  26:  Contamination Control for Incoming Components to Classified Areas Download PDF
Chapter  27:  Aseptic Processing of Sterile Dosage Forms Download PDF
Chapter  28:  Manual Aseptic Processes Download PDF
Chapter  29:  Aseptic Processing for Sterile Bulk Pharmaceutical Chemicals Download PDF
Chapter  30:  Qualification and Validation of Advanced Aseptic Processing Technologies Download PDF
Chapter  31:  Total Particle Counts Download PDF
Chapter  32:  Environmental Monitoring Download PDF
Chapter  33:  Validation of Container Preparation Processes Download PDF
Chapter  34:  Validation of Lyophilization Download PDF
Chapter  35:  Validation of Primary Packaging, Inspection and Secondary Packaging Processes Download PDF
Chapter  36:  Validation of Active Pharmaceutical Ingredients Download PDF
Chapter  37:  Cell Culture Process Validation Including Cell Bank Qualification Download PDF
Chapter  38:  Validation of Recovery and Purification Processes Download PDF
Chapter  39:  Validation of Process Chromatography Download PDF
Chapter  40:  Single-Use Technologies and Systems Download PDF
Chapter  41:  Considerations for Process Validation for Cell and Gene Therapies Download PDF
Chapter  42:  Validation of Solid Dosage Finished Goods Download PDF
Chapter  43:  Validation of Oral/Topical Liquids and Semi-Solids Download PDF
Chapter  44:  Validation of Non-Sterile Packaging Operations Download PDF
Chapter  45:  Cleaning Validation for the Pharmaceutical, Biopharmaceutical, Cosmetic, Nutraceutical, Medical Device and Diagnostic Industries Download PDF
Chapter  46:  Validation of Training Download PDF
Chapter  47:  Vendor Qualification and Validation Download PDF
Chapter  48:  Validation for Clinical Manufacturing Download PDF
Chapter  49:  Validation of New Products Download PDF
Chapter  50:  Retrospective Validation Download PDF
Chapter  51:  Validation and Six Sigma Download PDF
Chapter  52:  Validation and Contract Manufacturing Download PDF
Chapter  53:  Computerized Systems Validation Download PDF
Chapter  54:  Risk Based Validation of a Laboratory Information Management System (LIMS) Download PDF
Chapter  55:  Control Systems Validation Download PDF
Chapter  56:  Process Analytical Technology (PAT) Download PDF
Chapter  57:  Validation of Analytical Procedures and Physical Methods Download PDF
Chapter  58:  Validation of Microbiological Methods Download PDF
Chapter  59:  Rapid Methods for Pharmaceutical Processing and Their Validation Download PDF
Chapter  60:  Extractables and Leachables in Drug Products Download PDF
Chapter  61:  Evolution and Implementation of Validation in the United States Download PDF
Chapter  62:  Validation in Europe—What Are the Differences? Download PDF
Chapter  63:  Japanese Approach to Validation Download PDF
Chapter  64:  Organization of Validation in a Multinational Pharmaceutical Company Download PDF
Chapter  65:  Validation in a Small Pharmaceutical Company Download PDF
Chapter  66:  Regulatory Aspects of Process Validation in the United States Download PDF
Chapter  67:  The Future of Validation Download PDF
Index Download PDF
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