In this post Standard Operating Procedure of Reconciliation and destruction of leftover coded packing materials in Pharmaceuticals is describe.
1.0 OBJECTIVE:
To lay down the procedure for Reconciliation and destruction of leftover coded packing materials.
2.0 SCOPE:
This procedure is applicable for Reconciliation and destruction of leftover coded packing
materials.
3.0 RESPONSIBILITY:
Officer /Executive/Assistant Manager
Head Production: To ensure execution & compliance. Head QA: To ensure the compliance.
4.0 PROCEDURE:
4.1 Batch wise reconciliation shall be done as per the respective BPR.
4.2 Count/weigh the rejected material after completion of packing operation and collect in
separate poly bag for destruction with rejected label affix on it.
4.3 Record the rejects in the BPR. (Rejects will include all wrong printing, smudging for
primary and secondary packing material or rejected due to on-line detection of any defect.).
4.4 Enter the details in the ‘Reconciliation of Packing Material’ table in the BPR.
4.5 Follow the below mentioned procedure for destruction of various packing materials.
Aluminum Foil, PVC/ PVDC/Triplex Film:
4.6 On completion of the batch, weigh and record the foil rejections on the respective BPR.
4.6.1 Ensure that foil carry forward /Return the unused good quantity of Aluminum foil, PVC/PVDC
cold form laminate etc. to warehouse as per -
4.6.2 SOP-Return of unused left over packing materials to store.
Collect all the rejected printed packing material (Printed aluminum Film, PVC/ PVDC film) and
transfer it to scrap area for destruction. Collect the material in poly-bag, tie it
4.6.3 properly and label for waste disposal.
4.7 Labels, Cartons, Leaflets and Catch Covers:
4.7.1 In case of cartons/ labels/catch covers rejected during overprinting, shall be kept in poly
bag with tie code and status label till packaging is completed.
4.7.2 On completion of batch count and record quantity of the rejected and unused (Overprinted or
blank) materials in BPR.
4.7.3 Destroy these materials by tearing into pieces and transfer to scrap areas per waste
disposal procedure.
4.8 Corrugated boxes:
4.8.1 On completion of batch, count and record quantity of corrugated boxes. Deface and tear
4.8.2 these shipper and transfer to scrap area as per waste disposal procedure.
Transfer the above material to scrap yard and record it into the scrap transfer record.
4.8.3 Ensure that the boxes, labels, cartons, inserts, catch covers are torn into pieces. Ensure
that the scrap is not containing any product.
5.0 ANNEXURE(S):
Nil
6.0 REFERENCE (S):
SOP: Return of unused leftover packing materials to Store.
7.0 ABBREVIATION (S) /DEFINITION (S):
BPR : Batch Packing Record
PVDC : Poly Vinyl dichloride
PVC : Poly Vinyl chloride
HDPE : High Density Polyethylene
LDPE : Low Density Polyethylene
SOP : Standard Operating Procedure