VALIDATION TEAM:
| Designation | Name | Signature | Date |
| QA Officer | |||
| Production Chemist | |||
| Production Manager | |||
| QA Manager |
| Name of Visual Inspector | |
| Date of Commencement | |
| Date of Completion | |
| Training Done | Yes No |
| Date of Training | |
| Used Capsules Shell | Oval Oblong |
| Used Colour of Capsules | |
| Signature of Visual Inspector / Date |
- IDENTIFICATION OF REJECTED CAPSULES:
Date: _______________
| Type of Rejected Capsules | Observation | Remark |
| Banana Shape | Yes No | |
| Empty Capsules | Yes No | |
| Leak Capsules | Yes No | |
| Under sized Shape | Yes No | |
| Over size Capsules | Yes No | |
| D-Shaped Capsules | Yes No |
- MAXIMUM DURATION OF INSPECTION ON DIFFER DAYS
Date: _______________
| Time | Qty. Used for Observation | Rejected Capsules | Remarks |
| For 1 Hours | |||
| For 2 Hours | |||
| For 3 Hours | |||
| For 4 Hours |
Date: ______________
| Time | Qty. Used for Observation | Rejected Capsules | Remarks |
| For 1 Hours | |||
| For 2 Hours | |||
| For 3 Hours | |||
| For 4 Hours |
Date: _____________
| Time | Qty. Used for Observation | Rejected Capsules | Remarks |
| For 1 Hours | |||
| For 2 Hours | |||
| For 3 Hours | |||
| For 4 Hours |
- MAXIMUM SPEED OF INSPECTION ON DIFFER DAYS
Date: _______________
| No. of Capsules check | Rejected Capsules | Time Duration | Capsule / Hours | Remarks | |
| Average of Capsule / Hours |
Date: ______________
| No. of Capsules check | Rejected Capsules | Time Duration | Capsule / Hours | Remarks | |
| Average of Capsule / Hours |
Date: ______________
| No. of Capsules check | Rejected Capsules | Time Duration | Capsule / Hours | Remarks | |
| Average of Capsule / Hours |
- QUALITY OF INSPECTION ON DIFFER DAYS
Date: _______________
| No. of Capsules check | Rejected Capsules | Time Duration | Observed Rejected Capsules | Remarks | |
| 1000 Capsules | 10 Capsules | ||||
| 1000 Capsules | 10 Capsules | ||||
| 1000 Capsules | 10 Capsules |
Note: Minimum 9 rejected capsules should be recovered.
Date: ______________
| No. of Capsules check | Rejected Capsules | Time Duration | Observed Rejected Capsules | Remarks | |
| 1000 Capsules | 10 Capsules | ||||
| 1000 Capsules | 10 Capsules | ||||
| 1000 Capsules | 10 Capsules |
Note: Minimum 9 rejected capsules should be recovered.
Date: ______________
| No. of Capsules check | Rejected Capsules | Time Duration | Observed Rejected Capsules | Remarks | |
| 1000 Capsules | 10 Capsules | ||||
| 1000 Capsules | 10 Capsules | ||||
| 1000 Capsules | 10 Capsules |
Note: Minimum 9 rejected capsules should be recovered.
Remarks: ________________ is validated / does not validate for visual inspection of Softgel capsules.
