Pharmaceutical Quality Assurance - Unit 1

Syllabus

Quality Assurance and Quality Management concepts: Definition and concept of Qualitycontrol, 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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