Pharmaceutical Calibration, Validation and Qualification: A Comprehensive Approach

This up-to-date and unique monograph covers the different aspects of pharmaceutical validation, calibration, qualification and documentation. It discusses the various methods and processes under all these heads. It includes eight major sections and exhaustively covers each topic.The book includes in...

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Autors principals: Shukla, Shiv Shankar (Autor), Pandey, Ravindra Kumar (Autor), Gidwani, Beena (Autor), Kalyani, Gunjan (Autor)
Autor corporatiu: SpringerLink (Online service)
Format: Electrònic eBook
Idioma:anglès
Publicat: Singapore : Springer Nature Singapore : Imprint: Springer, 2023.
Edició:1st ed. 2023.
Matèries:
Accés en línia:https://doi.org/10.1007/978-981-19-9002-1
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Taula de continguts:
  • Chapter 1. Introduction to Calibration
  • Chapter 2. Errors and Uncertainties in Calibrations
  • Chapter 3. Calibration Methods and Procedures
  • Chapter 4. Calibration Software Support
  • Chapter 5. Objectives of Qualification
  • Chapter 6. Approach to the Qualification process
  • Chapter 7. Objectives, Methods and Roles of Verification
  • Chapter 8. Improvement in Software Quality
  • Chapter 9. General Principles of Validation
  • Chapter 10. Process Validation and its Types
  • Chapter 11. Pharmaceutical Equipment Validation
  • Chapter 12. Cleaning Validation for the Pharmaceutical, Biopharmaceutical, Nutraceuticals
  • Chapter 13. Validation of Pharmaceutical Dosages Form – Validation of Tablets, Capsules, Liquids and Semisolids
  • Chapter 14. Approach for Herbal Standardization
  • Chapter 15. Regulatory requirements for herbal medicines in India
  • Chapter 16. Expert Opinion on the Basis of the Content.