Pharmaceutical Calibration, Validation and Qualification: A Comprehensive Approach

ISBN-13: 9789811990014 / Angielski / Twarda / 2023 / 215 str.

Shiv Shankar Shukla; Ravindra Kumar Pandey; Beena Gidwani

Opis

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.

Spis treści

Part I Calibration

1.        

Introduction to Calibration

2.        

Errors and Uncertainties in Calibrations

3.        

Calibration Methods and Procedures

4.        

Calibration Software Support

Part II Qualification

5.        

Objectives of Qualification

6.        

Approach to the Qualification process 

7.        

Implementation and Monitoring of Qualifications

Part III Verification

8.        

Objectives of Verification

9.        

Methods of Verification

10.    

Role of Verification

11.    

Improvement in Software Quality

Part IV Validation

12.    

General Principles of Validation

13.    

Process Validation and its Types

14.    

Regulatory Basis for Process Validation

15.    

Pharmaceutical Facility Validation

16.    

Pharmaceutical Equipment Validation

17.    

Software Validation

18.    

Validation Planning

Part V Analytical Validation

19.    

Validation of Analytical Methods

20.    

Harmonization, GMPs, and Validation

21.    

Cleaning Validation for the Pharmaceutical, Biopharmaceutical, Nutraceuticals

22.    

Statistical Tools and Approaches to Validate Analytical Methods

Part VI Validation of Dosage forms

23.    

Validation of Solid Dosage Forms

24.    

Validation of Liquid Dosage Forms

25.    

Validation of Semi Solid Dosage Forms

26.    

Validation of Parenteral

27.    

Validation of Inhaled formulations

28.    

Validation of Biotechnology Processes

Part VII Validation of Herbals

29.    

Approach for Herbal Standardization

30.    

Regulatory Compliance of Herbal Medicines

31.    

Quality based Validation of Herbal Medicines

32.    

Novel Approaches for the Validation of Herbals

Part VIII Documentation

33.    

Process Documentation and related approaches

34.    

QUATRE Approach

35.    

Documentation Management and Evaluation

36.    

Change Control

Part IX

Expert Opinion with special emphasis on comparison of the validation criteria concerning the main pharmaceutical authorities around the globe

 

O autorze

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.