Pharmaceutical process validation /
Pharmaceutical process validation /
edited by Robert A. Nash, Alfred H. Wachter.
- International Third edition, revised and expanded.
- xxxvi, 860 pages : Illustrations ; 24 cm
- Drugs and the pharmaceutical sciences ; 129 .
- Drugs and the pharmaceutical sciences ; v. 129. .
Includes bibliographical references and index.
Preface -- Contents -- Contributors -- Introduction -- Regulatory Basis for Process Validation -- Prospective Process Validation -- Retrospective Validation -- Sterilization Validation -- Validation of Solid Dosage Forms -- Validation for Medical Devices -- Validation of Biotechnology Processes -- Transdermal Process Validation -- Validation of Lyophilization -- Validation of Inhalation Aerosols -- Process Validation of Pharmaceutical Ingredients -- Qualification of Water and Air Handling Systems -- Equipment and Facility Qualification -- Validation and Verification of Cleaning Processes.
0824708385 (alk. paper)
Pharmaceutical industry--Quality control.
Drugs--Standards--United States.
Drug Evaluation--standards--United States.
Drug Industry--standards--United States.
Quality Control.
615.10685 / P
Includes bibliographical references and index.
Preface -- Contents -- Contributors -- Introduction -- Regulatory Basis for Process Validation -- Prospective Process Validation -- Retrospective Validation -- Sterilization Validation -- Validation of Solid Dosage Forms -- Validation for Medical Devices -- Validation of Biotechnology Processes -- Transdermal Process Validation -- Validation of Lyophilization -- Validation of Inhalation Aerosols -- Process Validation of Pharmaceutical Ingredients -- Qualification of Water and Air Handling Systems -- Equipment and Facility Qualification -- Validation and Verification of Cleaning Processes.
0824708385 (alk. paper)
Pharmaceutical industry--Quality control.
Drugs--Standards--United States.
Drug Evaluation--standards--United States.
Drug Industry--standards--United States.
Quality Control.
615.10685 / P