1 Indian Pharmaceutical Industry
2 The Concept of Quality Assurance , Quality Control And Good Manufacturing Practices
3 Correlation of QA , QC , And GMP
4 Good Manufacturing Practice (GMP)
5 Good Laboratory Practice (GLP)
7 New Drug Application (NDA)
8 Abbreviated New Drug Application
9 Regulatory Agencies
About the Book :
It gives us an immense pleasure to present a book entitled “Steps in Quality Assurance in Pharmaceuticals’’. Need to write this book is ever increasing the data on the subject matter of quality assurance.
The text may be used for a semester or annual pattern, depending on the desired depth of coverage. All topics may not be necessary for a one-semester course; selection of material could depend on the course objectives and subsequent curriculum. A full-year course may use the entire book with detailed discussion and additional readings as desired. For pharmacy students, an understanding of the basic concepts in this book will be followed by courses in quality assurance. For graduate students, this book will provide a broad context in which they study and investigate problems in their chosen pharmaceutical specialty. Although this book is written as a text, it will also be an asset to scientists, pharmacists, researchers, teachers and other pharma professionals who need a simple overview of the concept of quality assurance, quality control and good manufacturing practices.