SOP for disposal of rejected primary and secondary packing materials
Pharma Editor
November 28, 2016
Production
3,771 Views
- Objective:
- To lay down a procedure for Disposal of rejected primary & secondary packing materials.
- Scope
- This SOP is applicable on procedure for Disposal of rejected primary & secondary packing materials for Production dry powder Injection facility.
- Responsibility
- Officers or above – Production.
- Accountability
- Production Head.
- Abbreviations
- SOP : Standard Operating Procedure.
- WFI : Water for Injection.
- Procedure
- Disposalof Primary Packing Materials :-
- After completion of day’s work collect the rejected vials (Moulding defects, crack & broken vials) in a separate poly bag.
- Count & checkthe collected vials & enter the quantity in Primary Packing Material Destruction Record in Batch Production Record.
- Crushthe rejected vials and transfer the glass pieces in a poly bag.
- After completion of day’s work collect the rejected rubber stoppers (Shape defects, dirty rubber stoppers) in a separate poly bag.
- Count & checkthe collected rubber stoppers & enter the quantity in Primary Packing Material Destruction Record in Batch Production Record.
- After completion of day’s work collect the rejected aluminum seals (Shape defects, dirty & spot) in a separate poly bag.
- Count & checkthe collected aluminum seals & enter the quantity in Primary Packing Material Destruction Record in Batch Production Record.
- After verification of production supervisor / officer send the rejected vials, rubber stoppers and aluminum seals to the scrap area for further destruction.
- Disposal of Secondary Packing Materials:
- After completion of day’s work collect the rejected secondary packing materials (Labels, unit cartons, multi cartons, inserts (literature) & corrugated boxes) in separate poly bags.
- Count & checkthe rejected packing materials (Labels, cartons & corrugated boxes) & enter the quantity in secondary Packing Material Destruction Record in Batch Production Record.
- Check that all the Printed Packing Material is torn after counting.
- Collect,countand check the rejected WFI ampoules and puncture them after checking. Record the total quantity of rejected ampoules in the secondary packing material destruction record in Batch Production Record.
- Collect, count & check the rejected corrugated boxes and tornthem after checking. Record the total quantity of rejected corrugated boxes in the Secondary Packing Material Destruction record in Batch Production Record.
- After verification of production supervisor / officer send the rejected Labels, cartons, inserts, corrugated boxes & ampoules to the scrap area for further destruction.
- Sendthe empty corrugated boxes of decartoned material, rejected rubber stereos and release paper of label roll to the Scrap area for further destruction.
- Forms and Records (Annexures)
- Not Applicable
- Distribution
- Master copy – Quality Assurance
- Controlled copies- Quality Assurance, Production, Quality Control
- History
| Date |
Revision Number |
Reason for Revision
|
| – |
00 |
New SOP |
