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Quality Assurance B Pharm Notes - Calibration and Validation, Warehousing, Complaints and Document Maintenance, Quality Control and Good Laboratory Practices
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Quality Assurance and Quality Management Concepts - B Pharm Notes Unit 1

1. Definition and concept of Quality control, Quality assurance and GMP
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2. Total Quality Management (TQM)
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3.ICH Guidelines:purpose, participants, process of harmonization, Brief overview of QSEM, with special emphasis on Q-series guidelines, ICH stability testing guidelines
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4. Quality by design (QbD): Definition, overview, elements of QbD program, tools


5. ISO 9000 & ISO14000: Overview, Benefits, Elements, steps for registration
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6. NABL accreditation: Principles and procedures
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