Pharmaceutical Quality Assurance: ISO Standards, QbD, Validation & Sterile Manufacturing B.Pharmacy 6th Semester 2025 (2024-2025) Previous Year's Question Papers/Notes Download - HK Technical PGIMS

Previous year question paper of quality assurance 6th sem

This B.Pharm Quality Assurance exam paper covers critical topics like ISO standards, QbD (Quality by Design), validation protocols, and sterile manufacturing requirements, essential for pharmaceutical professionals.

Key Highlights:

1. Quality Standards & Guidelines:

   • ISO 9000/14000: Benefits, features, and environmental management.

   • QbD Elements: Design space, critical quality attributes (CQAs), and risk assessment.

   • QSEM & Q-Series Guidelines: ICH frameworks for quality assurance.

2. Validation & Documentation:

   • Instrument Qualification: UV-Vis spectrophotometer, pH meter protocols.

   • Batch/Master Formula Records: Significance and maintenance.

   • Non-Clinical Lab Studies: Audit protocols and disqualification criteria.

3. Sterile Manufacturing & Waste Management:

   • Plant Layout: Environmental controls (HVAC, cleanrooms).

   • Waste Disposal: Regulatory compliance and best practices.