| Edition |
Third edition. |
| Description |
1 online resource (xvi, 737 pages) : illustrations |
| Bibliography |
Includes bibliographical references and index. |
| Contents |
Why validation? -- Organizing for validation -- Validation and facility design -- Validation of environmental control systems used in parenteral facilities -- Validation of critical utilities -- The validation of pharmaceutical water systems -- Calibration and metrology -- Temperature measurements -- Qualification and change control -- Microbiology and sterilization processes -- F, D, and z values -- Steam sterilization in autoclaves -- Validation of terminal sterilization -- Steam sterilization-in-place technology and validation -- Dry heat sterilization and depyrogrenation validation and monitoring -- Validation of ethylene oxide sterilization processes -- Validation of chlorine dioxide sterilization -- Validation of the radiation sterilization of pharmaceuticals -- Isolator decontamination -- Validation of sterilizing-grade filters -- Cleaning and disinfction in the control of pharmaceutical cleanrooms -- Aseptic processing for dosage form manufacture : organization and validation -- Validation of aseptic processing for bulk pharmaceutical chemicals -- Validation of manual aseptic processes -- Monitoring of nonviable particles -- Viable environmental microbiological monitoring -- Validation of container preparation processes -- Validation of lyophilization -- Qualification concerns for isolator systems -- Validation of solid dosage finished goods -- Validation of oral/topical liquids and semisolids -- Validation of packaging operations -- Validation of bulk pharmaceutical chemicals -- Validation of recovery and purification processes -- Validation of process chromatography -- Cell culture process validation -- Cleaning validation for the pharmaceutical, biopharmaceutical, cosmetic, nutraceutical, medical device, and diagnostic industries -- Validation of training -- Vendor qualification and validation -- Validation for clinical manufacturing -- Validation of new products -- Retrospective validation -- Validation and six sigma -- Validation and contract manufacturing -- Process analytical technology and validation -- Computerized systems validation -- Validation of control systems -- Risk-based validation of a laboratory information management system -- Validation of laboratory information systems -- Validation of analytical procedures and physical methods -- Validation of microbiological methods -- Implementation of validation in the United States -- The European approach to validation : a microbiological perspective -- Japanese regulatory requirements -- Managing validation in a multinational company -- Validation in a small pharmaceutical company -- Regulatory aspects of validation -- Validation : what's next? |
| Note |
Description based on print version record. |
|
GMD: electronic resource. |
| Subject |
Sterilization.
|
|
Pharmaceutical technology -- Quality control.
|
|
Pharmaceutical technology -- Standards.
|
|
Technology, Pharmaceutical.
|
|
Quality Control.
|
|
Sterilization -- methods.
|
| Added Author |
Agalloco, James P., 1948-
|
|
Carleton, Frederick J., 1925-
|
|
