Quality Assurance and Quality Management Concepts - B Pharm Notes Unit 1
Posted: 14 Mar 2021, 11:19
Quality Assurance and Quality Management Concepts - B Pharm Notes Unit 1
1. Definition and concept of Quality control, Quality assurance and GMP
2. Total Quality Management (TQM)
3.ICH Guidelines:purpose, participants, process of harmonization, Brief overview of QSEM, with special emphasis on Q-series guidelines, ICH stability testing guidelines
4. Quality by design (QbD): Definition, overview, elements of QbD program, tools
5. ISO 9000 & ISO14000: Overview, Benefits, Elements, steps for registration
6. NABL accreditation: Principles and procedures
1. Definition and concept of Quality control, Quality assurance and GMP
2. Total Quality Management (TQM)
3.ICH Guidelines:purpose, participants, process of harmonization, Brief overview of QSEM, with special emphasis on Q-series guidelines, ICH stability testing guidelines
4. Quality by design (QbD): Definition, overview, elements of QbD program, tools
5. ISO 9000 & ISO14000: Overview, Benefits, Elements, steps for registration
6. NABL accreditation: Principles and procedures