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About The Book
The content of this book goes beyond the syllabus by the Pharmacy Council of India for B. Pharm 6th semester as it tries to clear the concepts or principles in simple language. Quality Assurance is an essential subject especially for professionals in pharmaceutical industry. The principles being taught in this subject are related to the behavior observed during development/manufacturing of a formulation.
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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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