Regulatory Affairs
Regulatory Affairs
- Master Project Quality Plan
- Project Quality Risk Assessment documents
- Equipment Quality Risk Assessment documents
- Process Quality Risk Assessment documents
- Quality Impact Assessment documents for assessing equipment as Direct, Indirect and No Impact on Quality
- Quality Manual & Training Manuals
- Site Master File
- Change Control System
- Deviation Control System
- Incident Control System
- Out of Specification System
- Market Complaints and Product Recall Handling System
- Internal Audit / Self Inspection
- Manufacturing Activities Monitoring System
- Analytical Assurance & Monitoring System
- Microbiology Assurance monitoring system
- Engineering Assurance Monitoring System
- Documentation System
- CAPA System
- Annual Product Review System
- Management Review System
- Calibration Policy and Master Calibration Schedule
- Development of Training Schedule for all Plant Personnel
- Standard Operating Procedures for Production Process, Quality Control, Warehouse, Engineering
