Regulatory Documentation Portfolio:
- Qualification Risk Assessment
- All department SOP’s & Formats
- Research and Development
- Product Development Lab
- Technology Transfer Department
- Analytical Department
- Corporate Quality Assurance
- Plant Quality Assurance
- Quality Control
- Microbiology Department
- Production department
- Engineering Department
- Maintenance Department
-
Ware House Department
- Raw Materials Ware House
- Finished Goods Ware House
- Distribution Finished Goods
- Analytical Development Protocol Report
- Lab Scale Batch Report
- Pilot Scale Batch Report
- Technology Transfer Dossier
- Risk Base Approach
- Protocol and Report
-
Scale –up Batch Record
-
Exhibit Batch record
-
Process Validation
-
Process Equipment Cleaning Validation
-
Facility Cleaning Validation
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