Quality Management System
We provide technical guidance to design, prepare and implement Quality Management System as per US FDA, EU GMP, PIC/s, WHO, NSF & ISO Guidelines.
Key Pillars of Quality Management System Areas Follows:
- Quality Assurance System
- Production System
- Facilities and Equipment
- System Laboratory Control
- System Material System
- Packaging & Labeling Control System
Key Documents of Quality Management System:
Standard Operating Procedure (SOPs)
- Quality Assurance,
- Quality Control,
- Engineering,
- Warehouse,
- Purchase,
- Human Resource,
- Research & Development &
- Manufacturing department.
Validation & Qualification Documents
- Validation Master Plan
- Site Master File
- Facility qualification
- Cleaning Validation Protocol
- Equipment Qualification
- Instrument Qualification
- HVAC Qualification
- Water System Validation
- Compressed Air System Validation
- Nitrogen System Validation
- Stability Studies
- Process Validation
- Analytical Method Validation
- Technology Transfer
- Aseptic Processing of Sterile Products