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

chapter 1|4 pages

Why Validation?

chapter 2|6 pages

Organizing for Validation

chapter 3|16 pages

Validation and Facility Design

chapter 5|8 pages

Validation of Critical Utilities

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 19|10 pages

Isolator Decontamination

chapter 20|16 pages

Validation of Sterilizing-Grade Filters

chapter 24|6 pages

Validation of Manual Aseptic Processes

chapter 25|18 pages

Monitoring of Nonviable Particles

chapter 28|18 pages

Validation of Lyophilization

chapter 30|14 pages

Validation of Solid Dosage Finished Goods

chapter 32|14 pages

Validation of Packaging Operations

chapter 33|12 pages

Validation of Bulk Pharmaceutical Chemicals

chapter 35|8 pages

Validation of Process Chromatography

chapter 36|10 pages

Cell Culture Process Validation

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 49|14 pages

Validation of Laboratory Information Systems

chapter 51|6 pages

Validation of Microbiological Methods

chapter 54|12 pages

Japanese Regulatory Requirements

chapter 57|6 pages

Regulatory Aspects of Validation

chapter 58|4 pages

Validation—What’s Next?