by - OBJECTIVE
To describe the procedure for disposal of rejected in- process and finished products (drug / Food
Product ).
- SCOPE
This SOP is applicable for the procedure of destruction of finished products & rejection during in Process of production activity.
3.0 RESPONSIBILITY
Production Chemist & operator : To follow the procedure
4.0 ACCOUNTABILTY
QA & Head Production : For system compliance
5.0 PROCEDURE
5.1 Procedure in manufacturing sections.
5.1.1 All drums or container after use shall be sent to scrap yard after defacing/crossing marking the label or printing.
5.1.2 All discarded empty poly bags (used for Capsules, raw materials, etc.) shall be collected in a waste bin. These poly bags shall be collected by housekeeping person and sent to scrap yard.
5.1.3 Torn / Defected status labels strings cling film adhesive tapes/used cleaning cloth shall be collected in waste bin. Housekeeping person shall collect the material and send it to scrap yard.
5.1.4 Rejected in-process products shall be destroyed by dispersing / dissolving in sufficient quantity of water and then draining it of in washing room.
5.1.5 Disposal of rejected capsules during the initial run from encapsulation machine or from any non-conformance necessitating rejection shall be destroyed by dissolving / dispersing in water and then draining it of in washing room.
5.1.6 Gelatin net generated during the encapsulation shall be collected in poly bags & sent to scrap yard for disposal.
5.2 Procedure in packaging section.
5.2.1 Rejected packaging material / excess overprinted packaging materials like labels, cartons, etc, after counting shall be collected in poly bags, labeled “For Destruction” in its status label.
5.2.2 After completion of the batch these materials shall be destroyed by tearing it in to small pieces or
Cut by scissors record in BPR of respective product under packing material and batch reconciliation.
5.2.3 Remove the capsules from the rejected blisters & collect in two poly bags. One for good capsules another for rejection during blistering.
5.2.4 Disposal of rejected capsules during the initial run of blister machine or from any non-conformance necessitating rejection shall be destroyed by dissolving / dispersing in water and then draining it of quantity of rejects shall be mentioned in yield reconciliation record.
5.2.5 Collect emptied blister in shipper and empty cartons in poly bags.
5.2.6 Cut the emptied blister to ensure mutilation using scissors/cutters.
5.2.7 Tear off the rejected empty cartons by hand or by shredding machine.
5.2.8 Collect the cuttings of cartons, aluminum & PVC foil in poly bags and transfer to scrap yard for further disposal.
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
| Sr.No | Annexure No. | Title | Format No. |
| 1 | NA | NA | NA |
- 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 |
