SOP for Dispensing of Packaging Material

In short: This example SOP explains how a warehouse issues (dispenses) packaging material such as cartons, foils, films, labels and bottles to production against a signed pick list, with batch-wise segregation, counting rules and a double check before handover. Adapt the steps and quantities to your own quality system.

Why controlled issue matters

Packaging errors, especially mix-ups of printed material, are a leading cause of product recalls. EU GMP Chapter 5 says packaging materials are to be issued for use only by authorised personnel following an approved, documented procedure, that printed materials are stored securely and that cut labels and loose printed items travel in separate closed containers (5.46). Each delivery or batch of printed or primary packaging material is to carry its own reference number (5.47). The packaging department then checks quantity, identity and conformity with the packaging instructions on delivery (5.52), and any significant or unusual discrepancy at reconciliation is investigated and accounted for before release (5.61). In the US, 21 CFR 211.122 requires written procedures for handling labelling and packaging materials, and 21 CFR 211.125 requires labelling issued for a batch to be tightly controlled, checked for identity against the master/batch record, and reconciled (issued, used, returned), with discrepancies outside narrow preset limits based on historical operating data investigated (211.125(c)).

Example SOP

Values and formats below are example in-house criteria; replace them with those of your own system.

1. Purpose

To define the procedure for issuing (dispensing) packaging materials to production.

2. Scope

All packaging materials issued to production for packing drug products at the manufacturing site, for example corrugated shippers, primary and secondary packaging material, aluminium foil, PVC/PVDC film, BOPP tape, inserts, bottles, caps and sticker labels.

3. References

In-house procedures; EU GMP Part I Chapter 5; 21 CFR 211.122 and 211.125.

4. Procedure

Obtain the work order issue (material pick-up list) generated by the ERP/software or manually, signed by the production person (Annexure 1).
Dispense only against that list. Collect material from the location codes on the list, on pallets or cage trolleys.
Check the net weight on the quarantine (approved) label for foil, PVC and PVDC film. For show boxes, inserts, sample boxes, thermocol boxes, HDPE bottles, caps and sticker labels, check the quantity stated on the label.
Before issuing primary or secondary packaging material, scan the barcode on the quarantine/approval coupon.
Arrange the material for one batch on one cage trolley; use a separate trolley for each batch. Print the “Dispensed Material” label (Annexure 4) and affix it to the trolley.
Cross-check all material against the pick-up list and against the outer label by opening each intact pack.
Put loose quantities in a transparent polybag after verifying by weighing or counting. Affix a status label (Annexure 2) on the polybag for traceability.
A store representative performs a final check of loose and intended quantities during dispensing.
Keep printed and dispensed packaging materials segregated at every step of issue so that mix-ups cannot occur.
Return the remaining quantity to its location with the status label (Annexure 3) and mark the box “LOOSE” with a permanent marker.
Ask the production person to cross-check the issued material and sign the pick-up list.
Hand over the confirmed work order copy (Annexure 5) to the packing officer, take their signature on the store copy, lock the material with a single-use cable tie and transfer it to the packing department.

5. Counting guideline

Sr. No.	Items	Counting procedure
1	Shippers, silica gel, coolant bags, BOPP tape	Physical counting
2	Show boxes, inserts, physician sample boxes, thermocol boxes, HDPE bottles, caps, aluminium poly-laminated bags	Intact packs by the quantity the supplier states on the pack; loose quantity by physical counting
3	Aluminium foil, PVC and PVDC film	By roll number on the issue order and the quarantine label on the roll
4	Sticker labels	By roll number on the issue order and the label on the roll

6. Annexures

Annexure formats (fields only; layout is site-specific):

Annexure 1, Material issue order / pick-up list: WO issue no., department, issue date, WO no./date, dispensed date, product, product code, BOM code, batch no., batch size, unit, operation, process.
Annexure 2, Loose material dispensed label: item code, item name, A.R. no., loose quantity, checked by (store sign/date).
Annexure 3, Remaining quantity label: item code, item name, A.R. no., remaining quantity, checked by (store sign/date).
Annexure 4, Dispensed material label: product, batch no., lot, stage, container no., dispensed by, dispensed date, WO issue no.
Annexure 5, Issue order (confirmed copy): same header fields as Annexure 1 with signatures of store and packing.

Records

Issue records and labels are batch records. Keep them at least 1 year after the expiry date of the respective product batch (EU GMP Part I Chapter 4 §4.11, or 5 years after QP certification if longer; 21 CFR 211.180(a)), longer if local law or the marketing authorisation requires.

Frequently asked questions

Why one cage trolley per batch? It prevents material of one batch being used for another and supports the batch-wise reconciliation expected by Chapter 5.

What happens to obsolete or unused coded packaging? Outdated or obsolete primary and printed packaging is destroyed and the disposal recorded (5.48); unused batch-coded material is destroyed after packing and recorded, with a documented procedure for any un-coded printed material returned to stock (5.62).

References

European Commission, EudraLex Volume 4, Part I, Chapter 5: Production, paragraphs 5.45–5.48, 5.52, 5.61, 5.62.
21 CFR 211.122 (materials examination and usage criteria) and 211.125 (labeling issuance), eCFR current.
EudraLex Volume 4, Part I, Chapter 4: Documentation, §4.11; 21 CFR 211.180(a).