by - OBJECTIVE
To describe the procedure for manual De-Blistering of defective Blisters
- SCOPE
This SOP is applicable for manual De-Blistering of defective Blisters in production area.
3.0 RESPONSIBILITY
Production Chemist & operator : To follow the procedure
4.0 ACCOUNTABILTY:
QA & Head Production : For system compliance
5.0 PROCEDURE:
5.1 Take care to wear hand gloves and nose mask while manual de-Blistering activity will perform.
5.2 Transfer defective strips to the respective area.
5.3 Remove capsule from defective strip by manual de-foiling.
5.4 De-foil the defective strip by manual mode and collected all capsule in separate poly bag.
5.5 Segregate De-foil capsule in recoverable and no recoverable capsule.
5.6 Recoverable capsule packed in concern batch and non-recoverable capsule destroyed Accordance to “Disposal of rejected in process and finish products”
6.0 TRAINING
Trainer : Head Production Department
Trainees : Staff and machine operator of production and QA chemist.
7.0 DISTRIBUTION
Master Copy : QA Department
Controlled Copy : Production Department
Display Copy : Production Department (If Required)
8.0 ATTACHMENTS
Nil.
- REFERENCES
In-house
10.0 ABBREVIATION
| Abbreviation | Extended Form |
| EG | Engineering |
| SOP | Standard Operating Procedure |
| QA | Quality Assurance |
| WH | Warehouse |
| NA | Not Applicable |
| MB | Microbiology |
11.0 REVISION HISTORY OF CHANGE
| Sr. No. | Date | Revision Details | Revision No. |
| 1 | NA | New SOP | 00 |
