Pharmaceutical calibration, validation and qualification : a comprehensive approach / Shiv Shankar Shukla, Ravindra Kumar Pandey, Beena Gidwani, Gunjan Kalyani.
Shukla, Shiv Shankar, author.; Pandey, Ravindra Kumar, author.; Gidwani, Beena, author.; Kalyani, Gunjan, author.
2023
RS192
Available Online

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Title
Pharmaceutical calibration, validation and qualification : a comprehensive approach / Shiv Shankar Shukla, Ravindra Kumar Pandey, Beena Gidwani, Gunjan Kalyani.
Author
Shukla, Shiv Shankar, author.
ISBN
9789811990021 (electronic bk.)
9811990026 (electronic bk.)
9789811990014
9811990018
DOI
https://doi.org/10.1007/978-981-19-9002-1
Published
Singapore : Springer, 2023.
Language
English
Description
1 online resource (215 pages) : illustrations (black and white).
Item Number
10.1007/978-981-19-9002-1 doi
Call Number
RS192
Dewey Decimal Classification
615.1/9
Summary
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 interesting and timely topics like the Validation of herbals considering the increasing reliance on herbal medicines. It includes a section of validation of dosage forms, which is an essential topic for any pharmaceutical scientist. The chapters provide lucid illustrations, figures, flowcharts and other diagrams to facilitate understanding. A final section on 'expert opinion' provides a rundown about the global scenario to the readers. The book serves as a complete reference material for students, researchers and industry experts in the field of pharmaceutical sciences, medicinal chemistry and pharmacology.
Bibliography, etc. Note
Includes bibliographical references.
Access Note
Access limited to authorized users.
Digital File Characteristics
text file PDF
Source of Description
Description based on print version record.
Added Author
Pandey, Ravindra Kumar, author.
Gidwani, Beena, author.
Kalyani, Gunjan, author.
Available in Other Form
Pharmaceutical calibration, validation and qualification.
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Online Access
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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.

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