Pharmaceutical Quality Assurance : Unit 1 Notes : Bpharm

Download high-quality and well-structured Bpharm 6th-Semester notes in pdf format. The notes are in easy language and easy to remember covering all the topics of the syllabus.

Unit 1

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.

Pharmaceutical Quality Assurance : Unit 1 Notes : Bpharm

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Pharmaceutical Quality Assurance – Unit 2
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Pharmaceutical Quality Assurance – Unit 4
Pharmaceutical Quality Assurance – Unit 5

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