Pharmaceutical quality assurance unit-1st handwritten notes of 6th semester
Quality Assurance and Quality Management concepts: Definition and concept of Quality control, Quality assurance and GMP Total Quality Management (TQM): Definition, elements, philosophies ICH Guidelines: purpose, participants, process of harmonization, Brief overview of QSEM, with special emphasis on Q-series guidelines, ICH stability testing guidelines Quality by design (QbD): Definition, overview, elements of QbD program, tools ISO 9000 & ISO14000: Overview, Benefits, Elements, steps for registration NABL accreditation : Principles and procedures
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Index of Unit-1st
- Quality Assurance and Quality Management concepts: Definition and concept of Quality
- control, Quality assurance and GMP
- Total Quality Management (TQM): Definition, elements, philosophies
- ICH Guidelines: purpose, participants, process of harmonization, Brief overview of QSEM,
- with special emphasis on Q-series guidelines, ICH stability testing guidelines
- Quality by design (QbD): Definition, overview, elements of QbD program, tools
- ISO 9000 & ISO14000: Overview, Benefits, Elements, steps for registration
- NABL accreditation : Principles and procedures
