Pharmaceutical Process Validation : an International.
Nash, Robert A.
Pharmaceutical Process Validation : an International. - 3rd ed. - Hoboken : CRC Press, 2003. - 1 online resource (905 pages). - Drugs and the Pharmaceutical Sciences . - Drugs and the pharmaceutical sciences. .
Includes bibliographical references and index.
Front Cover; Preface; Contents; Contributors; Introduction; Chapter 1. Regulatory Basis for Process Validation; Chapter 2. Prospective Process Validation; 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 SystemsChapter 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 AssuranceChapter 22. Validation in Contract Manufacturing; Chapter 23. Terminology of Nonaseptic Process Validation; Chapter 24. Harmonization, GMPs, and Validation; Index; Back Cover.
The third edition of this text contains additional chapters which cover troubleshooting procedures, validation in contract manufacturing and current harmonization trends.
1135542872 9781135542870
Pharmaceutical industry--Quality control.
Drugs--Standards--United States.
Quality control.
Drugs--Inspection--United States.
Drug Evaluation--standards
Drug Industry--standards
Pharmaceutical Process Validation : an International. - 3rd ed. - Hoboken : CRC Press, 2003. - 1 online resource (905 pages). - Drugs and the Pharmaceutical Sciences . - Drugs and the pharmaceutical sciences. .
Includes bibliographical references and index.
Front Cover; Preface; Contents; Contributors; Introduction; Chapter 1. Regulatory Basis for Process Validation; Chapter 2. Prospective Process Validation; 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 SystemsChapter 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 AssuranceChapter 22. Validation in Contract Manufacturing; Chapter 23. Terminology of Nonaseptic Process Validation; Chapter 24. Harmonization, GMPs, and Validation; Index; Back Cover.
The third edition of this text contains additional chapters which cover troubleshooting procedures, validation in contract manufacturing and current harmonization trends.
1135542872 9781135542870
Pharmaceutical industry--Quality control.
Drugs--Standards--United States.
Quality control.
Drugs--Inspection--United States.
Drug Evaluation--standards
Drug Industry--standards