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 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.

Discusses all aspects of qualification, validation, calibration, verification and documentation Covers validation of dosage forms, analytical validation and equipment qualification Provides a bird's-eye view with detailed algorithms and protocols under one cover

Auteur
Dr. Shiv Shankar Shukla is presently a Professor in Columbia Institute of Pharmacy, Raipur, Chhattisgarh, India. He did his Doctorate from University Institute of Pharmacy, Pt. Ravi Shankar Shukla University. His thrust area is Method development, Chemical fingerprinting and Pharmaceutical analysis. He has various publications in journals of international and national repute. He has authored three books, Inflammation: Natural Resources and Its Applications in the Series: Springer Briefs in Immunology and Finger Printing Analysis & Quality Control Methods of Herbal Medicines and Insight on Genotoxicity in CRC Press Taylor & Francis Group, United Kingdom. He has written various book chapters published in books from reputed publishing houses.

Dr. Ravindra Kumar Pandey is presently a Professor in Columbia Institute of Pharmacy, Raipur, Chhattisgarh, India. He did his Doctorate from University Institute of Pharmacy, Pt. Ravi Shankar Shukla University. His thrust area is Herbal Drug development and Pharmacognosy. He has various publications in journals of international and national repute. He has authored three books, Inflammation: Natural Resources and Its Applications in the Series: Springer Briefs in Immunology and Finger Printing Analysis & Quality Control Methods of Herbal Medicines and Insight on Genotoxicity in CRC Press Taylor & Francis Group, United Kingdom. He has written various book chapters published in books from reputed publishing houses.

Dr. Beena Gidwani is presently an Associate Professor, Columbia Institute of Pharmacy, Raipur, Chhattisgarh, India. She did her postdoctoral studies under the Scheme of DST-SERB-NPDF and PhD from the University Institute of Pharmacy, Pt. Ravishankar Shukla University, Raipur (C.G.). She has various publications to her credit in various journals of international and national repute. She has authored two books, Techniques for Preparation of Host-Guest Inclusion Complexes: Techniques of Complexation in LAP LAMBERT Academic Publishing and Insight on Genotoxicity in CRC Press Taylor & Francis Group, United Kingdom, and two book chapters in reputed publishing houses.

Mr. Gunjan Kalyani is presently an Assistant Professor in Columbia Institute of Pharmacy, Raipur, Chhattisgarh, India. He did his postgraduate studies from the Chhattisgarh Swami Vivekanand Technical University (CSVTU), Bhilai, Chhattisgarh. His research area of interest includes Pharmaceutical analysis, Ethnomedicine and Medical anthropology. He has several publications to his credit in various journals of international and national repute. He has authored one book entitled Insight on Genotoxicity in CRC Press Taylor & Francis Group, United Kingdom, and two book chapters in reputed publishing houses.

Contenu
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.