Książki

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.

Pharmaceutical Calibration, Validation and Qualification: A Comprehensive Approach

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