chapter 1 Regulatory Basis for Process Validation / chapter 2 Prospective Process Validation and Paul Von Doehren / chapter 3 Retrospective Validation / chapter 4 Sterilization Validation / chapter 5 Validation of Solid Dosage Forms / chapter 6 Validation for Medical Devices / chapter 7 Validation of Biotechnology Processes / chapter 8 Transdermal Process Validation / chapter 9 Validation of Lyophilization / chapter 10 Validation of Inhalation Aerosols / chapter 11 Process Validation of Pharmaceutical Ingredients / chapter 12 Qualification of Water and Air Handling Systems / chapter 13 Equipment and Facility Qualification / chapter 14 Validation and Verification of Cleaning Processes / chapter 15 Validation of Analytical Methods and Processes / chapter 16 Computer System Validation: Controlling the Manufacturing Process / chapter 17 Integrated Packaging Validation / chapter 18 Analysis of Retrospective Production Data Using Quality Control Charts / chapter 19 Statistical Methods for Uniformity and Dissolution Testing / chapter 20 Change Control and SUPAC / chapter 21 Process Validation and Quality Assurance / chapter 22 Validation in Contract Manufacturing / chapter 23 Terminology of Nonaseptic Process Validation / chapter 24 Harmonization, GMPs, and Validation