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  • Writer's pictureLast Bench Pharmacist

B Pharm Pharmaceutical Quality Assurance Unit 1 PDF Notes


Buckle up, B-Pharmers! B Pharm Pharmaceutical Quality Assurance Unit 1 PDF Notes is your crash course in ensuring drug safety and efficacy. We'll dissect key concepts like "quality control" and "quality assurance", understanding how they work together with "Good Manufacturing Practices" (GMPs) to guarantee top-notch medicines. Get ready to explore "Total Quality Management" (TQM), a philosophy that puts quality at the heart of everything. We'll also navigate the world of "ICH Guidelines", international agreements ensuring drug quality across borders. Plus, we'll delve into "Quality by Design" (QbD), an approach that builds quality into drugs from the start. Don't forget "ISO standards" that set benchmarks for quality management, and "NABL accreditation", a mark of excellence for testing labs. This unit lays the groundwork for your journey to becoming a guardian of quality, ensuring patients receive safe and effective medications every time.


B Pharm Pharmaceutical Quality Assurance Notes
B Pharm Pharmaceutical Quality Assurance Notes

B Pharm Pharmaceutical Quality Assurance Unit 1 PDF Notes


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



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