DRA GOOD PHARMACEUTICAL PRACTICE: Mastering Good Pharmaceutical Practices

M.Pharmacy, 1st Semester, 2023 (2022-2023) - Previous Year's Question Paper

DRA101T Drug Regulatory Affairs

Maharshi Dayanand University

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HK Technical PGIMS

110 2 Report Feb 15, 2023

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DRA GOOD PHARMACEUTICAL PRACTICE: Mastering Good Pharmaceutical Practices M.Pharmacy 1st Semester 2023 (2022-2023) Previous Year's Question Papers/Notes Download - HK Technical PGIMS

Quality Assurance MPharmacy ICH Guidelines Quality by Design M.Pharm Syllabus Good Pharmaceutical Practices cGMP GLP Pharmaceutical Audits GDP Regulatory Compliance

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DRA GOOD PHARMACEUTICAL PRACTICE: Mastering Good Pharmaceutical Practices

Core Regulatory Frameworks Covered:
Quality Systems:
cGMP, GLP, GAMP, and Quality by Design (QbD) principles
Total Quality Management (TQM) and audit procedures
ICH guidelines and steering committee roles
Operational Excellence:
Site Master File requirements
Batch manufacturing records
Stability testing principles
Validation protocols (retrospective, steam)
Supply Chain Integrity:
Good Distribution Practices (GDP)
Cold chain management
FIFO (First In First Out) inventory control
Compliance & Documentation:
SOP development and implementation
Out-of-Specification (OOS) handling
Training documentation standards

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