Standard Operating Procedure for Issuance / Dispensing of Packaging Material (Packing Materials) like Corrugated box, Primary Packaging Material (PPM), Secondary Packing Material, Aluminum Foils, BOPP tape, PVC Foils, etc. which is required to pack the drug product.
Procedure for Packing Material Dispensing / Issuance
1.0 PURPOSE:
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- The purpose of this SOP is to define the procedure for the issuance of packing materials.
2.0 SCOPE:
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- This procedure is applicable to all packing materials to be issued to production for the packaging of drug product in the pharmaceutical manufacturing plants.
3.0 REFERENCES – SOP FOR ISSUANCE OF PACKING MATERIAL:
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- In house.
4.0 RESPONSIBILITIES:
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- The warehouse Officer/designee shall be responsible to follow the procedure of issuance of packaging materials.
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- Warehouse head to ensure that packing department get the material in time.
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- Production department to check the dispensed packing material against the work order issue.
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- Warehouse Officer/designee to ensure correct packing material to be issued to production.
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- Warehouse Officer/designee shall issue packing material in cage trolley by locking it with a one-time usable cable tie.
5.0 ABBREVIATIONS:
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- AR. No. : Analytical Report Number
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- BOPP: Biaxially Oriented Polypropylene
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- HDPE: High-Density Polyethylene
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- PVC: Poly Vinyl Chloride
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- PVDC: Poly Vinyl Di-Chloride
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- W.O.I: Work Order Issue
6.0 PROCEDURE FOR ISSUANCE OF PACKING MATERIAL:
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- Get the packing Metis/ERP/Other Software/Manually generated work order issue (Material pick up list) from the production department duly signed by production person.
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- Material is dispensed as per Metis/ERP/Other Software/Manually generated work order issue (Material pick up list) as per (Annexure 1).
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- Collect the packaging material as per the location code mentioned on the work order issue (Material pick up list) on pallets/cage trolley.
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- Check net weight on quarantine label in case of aluminium foil, PVC and PVDC film and in case of show boxes, inserts, sample boxes, thermo col boxes, HDPE bottles, caps and sticker labels check the quantity mention on quarantine label.
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- Ensure that before issuing of primary and secondary packaging material, first scan the barcode printed on the quarantine coupons.
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- Arrange issued primary and secondary packing material for a batch in the cage trolley. Use separate cage trolley for different batches. Print the “Dispensed Material” Metis/ERP/Other Software/Manually generated label as per (Annexure 4) affix on cage trolley.
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- Counter check all the materials against the work order issue (Pick up List).
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- Counter check all the materials against the outer label by opening each intact pack.
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- Dispense the loose quantity of packing materials in transparent polybag. Ensure the quantity by verification i.e. weighing or by counting.
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Affix or put a status label (Annexure 2) on the polybag for easy traceability.
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- Final check-up of the loose quantity, as well as the intended quantity, shall be verified by packaging material store representative during dispensing.
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- Segregation of dispensing printed packaging materials or the dispensed packaging material shall be ensured at all steps of issuance.
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- Remaining quantity transfer on the same location with the status label affixed on the box as per (Annexure 3) and written “LOOSE” with permanent marker on the box.
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- Call production person to cross-check the issued material and take the signature on unconfirmed material pick up the list after his verification.
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- Handover Metis/ERP/Other Software/Manually generated confirmed work order copy (Annexure 5) to packing officer and take signature on store copy and transfer material to packing department after locking it with a one-time usable cable tie.
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Note: Use the following guideline to packing materials-
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| Sr. No. | Items | Counting procedure |
| 1 | Shippers, Silica gel, Coolant bags & BOPP tape. | By physical counting |
| 2 | Show boxes, Inserts, Physician sample boxes, Thermocol Boxes, HDPE bottles, and caps/Aluminium poly laminated bags. | Intact packet wise by arriving quantity mentioned by the supplier/manufacturer on the packet. Loose qty. by physical counting. |
| 3 | Aluminum foil, PVC & PVDC films. | As per the roll no. mentioned on the packing material issue order and quarantine label affixed on the roll. |
| 4 | Sticker Labels | As per the roll no. mentioned on the packing material issue order and quarantine label affixed on the roll. |
7.0 ANNEXURES:
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Material Pick-up List (Annexure 1).
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| Material Issue Order |
| W O Issue No. : Department : W O Issue Date : |
| W O No. : W O Date : |
| Dispensed Date : |
| Product : |
| Product Code : BOM Code : Batch No. : |
| Batch Size : Unit : Operation : Process : |
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Loose Material Dispensed Label (Annexure 2).
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| ITEM CODE : ____________________ ITEM NAME : ____________________ A.R. NO. : ____________________ LOOSE QTY. : ____________________ CHECKED BYSTORE SIGN/DATE: ____________________ |
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Remaining Quantity Label (Annexure 3).
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| ITEM CODE : ____________________
ITEM NAME : ____________________ A.R. NO. : ____________________ REMAINING QUANTITY: ____________________ CHECKED BYSTORE SIGN/DATE : __________________ |
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Dispensed Material (Annexure 4).
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DISPENSED MATERIAL
———————————————————————————————————
Product :
Batch No. : Lot :
Stage :
Container No. :
Material Dispensed By :
Material Dispensed Date: Work Order Issue No. :
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Issue Material Order (Annexure 5).
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Issue Order
W O Issue No. : Department: W O Issue Date :
W O No. : W O Date :
Dispensed Date :
Product :
Product Code : BOM Code : Batch No. :
Batch Size : Unit : Operation : Process :