Pharmaceutical Quality Assurance Unit 1 Notes
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