Full Description
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.
Contents
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.
