Quality Control
|
Finished Product Quality Control |
Raw Material Quality Check
|
Protocol Master |
| Record of Analysis - RM and PM |
Record of Analysis Bulk, Intermediate /Finish. |
| Microbiological
Analysis |
Certificate of Analysis Bulk, Intermediate / Finish. |
| Analytical Analysis |
Release order for Bulk, Intermediate / Finish. |
| Public Lab Analysis |
Rejection order for Bulk, Intermediate / Finish. |
| RM Register I |
Sample Register |
| RM Register II |
Control Sample Register. |
| Control Sample Register |
Testing Process |
| RM Stability Study Analysis |
Micro Biology Testing |
| Certificate of Analysis - RM and PM |
Moisture Contents |
| Certificate of Analysis - Finished Product |
Sterility Controls |
| Approved / Rejection Slip |
Quality Audit Records |
| Destruction of QC Sample |
Calibration Records |
| Finish Product Stability Study IPQC |
Periodical Quality Control Dash Board |
| Stock Register as per Schedule - U |
Environmental Monitoring |
| Re-testing and its records |
After Sterilization Control |
| Calibration |
Cleaning and Line Clearance |
| QC Protocol Recording |
Periodic QC |
| Compliance Reporting |
|