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Pharmaceutical Process Validation : an International.

By: Contributor(s): Material type: TextTextSeries: Drugs and the pharmaceutical sciencesPublication details: Hoboken : CRC Press, 2003.Edition: 3rd edDescription: 1 online resource (905 pages)Content type:
Media type:
Carrier type:
ISBN:
  • 1135542872
  • 9781135542870
Subject(s): Additional physical formats: Print version:: Pharmaceutical Process Validation : An International.Online resources:
Contents:
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.
Summary: The third edition of this text contains additional chapters which cover troubleshooting procedures, validation in contract manufacturing and current harmonization trends.
Holdings
Item type Current library Call number Status Date due Barcode
Ebook TUS: Midlands, Main Library Athlone Online Available

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.

Print version record.

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