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BP606T

PHARMACEUTICAL QUALITY ASSURANCE

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Unit I: Quality Assurance and Quality Management Concepts

Syllabus Topics to Learn

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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Subject Overview

Course Code BP606T
Syllabus Status 100% PCI Aligned
Total Units 5 Units
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