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About The Book
The principles being taught in Quality Assurance are relevant with the behaviour observed during development / manufacturing of a drug formulation. The content of this book has been prepared primarily in accordance with the syllabus prepared by PCI for 6th semester of B.Pharm. Infact, it also provides the information beyond syllabus that is necessary to understand the practical application of concept or principle related to this subject.
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Content
1 Quality Assurance and Quality Management Concepts
2 ICH Guidelines
3 Quality by design (QbD)
4 ISO 9000 & ISO14000
5 Organization and personnel
6 Quality Control
7 Good Laboratory Practices
8 Complaints
9 Document maintenance in pharmaceutical industry
10 Calibration and Validation
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