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GullySystem
A practical guide

How old carton versions reach a pharma packing line

Ganesh HSStrategy and Technology, GullySystem
Practical advice · 4 min read

In this guide 6 sections
The short answer

Old cartons reach the line because stores still hold printed stock of a withdrawn artwork. Nobody tags that stock by version. Line clearance checks the batch but not the carton’s revision. Closing the gap takes version-tagged stock, a block on withdrawn items and a clearance step that reads the revision.

Where the old version hides

A carton changes for a reason: a new strength statement, a revised storage line, an updated manufacturer address or a label claim withdrawn after a regulatory query. The new artwork is approved. The old printed stock does not vanish.

It sits in the packing material store in bundles. It waits on a trolley left in the corridor, or in a returned lot from the printer. Half-used stacks linger on the line itself. A tired operator can pick up any of them at the next changeover.

Plants around Baddi, Barotiwala and Mehatpur run several products across shared lines, so a stray bundle has many chances to move.

  • Bundles in the packing material store
  • Returned or surplus lots from the printer
  • Half-used stacks left at the line
  • Pallets in the staging area near the filling hall
  • Leaflets stored apart from their cartons

Why stock by item code alone fails

Most stores track a carton by item code and quantity. When artwork changes, the code often stays the same, because the product has not changed. The system then shows one number for old and new together.

A storekeeper issuing against a batch packing order sees plenty of stock and issues the oldest bundle first. That is first in, first out, which is correct for most materials and exactly wrong when the oldest bundle is a withdrawn design.

The fix starts in the master data. Give each artwork revision its own code or a mandatory version field, and let stock balance show by version.

Make artwork approval reach the store

The approval of a new artwork usually lives in the regulatory affairs file and an email thread. The store never sees it. Connect the two: when a revision is approved, a date is set after which the previous version is blocked.

That block must do something. Old stock should move to a quarantine location and be marked for return to the printer or for destruction. Take it off the list of items the system can issue.

Record who authorised the destruction, the quantity and the witness. Destruction records are the first thing an inspector asks for after a mix-up.

  • Artwork revision and approval date
  • Cut-off date for the previous version
  • Quarantine location for withdrawn stock
  • Destruction record with quantity and witness

Line clearance has to read the revision

Line clearance is the check before a new batch starts: the line is empty of the last product’s cartons, leaflets, labels and rejects. Many checklists ask whether the line is clear. Few ask what revision of the carton is about to enter.

Add the question. The packing supervisor and the QA reviewer each compare two things. One is the revision printed on the issued carton, usually a small code near the fold. The other is the revision on the batch packing record.

Scan or sign, but make it a visible step with two names. Reconcile quantities at the end: issued, used, rejected and returned must add up, and any gap blocks batch release until explained.

Start with one product and one afternoon

Pick the product whose artwork changed most recently. Walk the store with the artwork list and count every bundle by revision. You will likely find at least one stray.

Write down how it got there. Was it a late approval, a printer overrun, a return from the line? That answer tells you which gate to build first.

Then tag what you have, block what is withdrawn and add the revision check to the next clearance form.

Carton revision control worksheet

A single worksheet holding a table: product, carton item code, current revision, previous revision, approval date, cut-off date, quantity by store location, action taken and signature. A second block lists line clearance questions with space for packing supervisor and QA initials.

Open a blank worksheet to print

Questions owners ask

How does a withdrawn carton end up on the packing line?

Printed stock of the old artwork stays in the store or at the line, while stock records show one number for all revisions. An operator picks the oldest bundle at changeover.

What should line clearance check about cartons?

It should check the revision printed on the carton against the batch packing record, in addition to checking that the line is empty. Two people should sign the comparison.

Should each artwork revision have its own item code?

Often yes. A separate code, or a required version field, lets the stock balance show old and new apart and lets the system block issue of the withdrawn version.

What records prove a withdrawn carton was destroyed?

Keep a destruction note with item code, revision, quantity, date, the person who authorised it and a witness. File it with the artwork change record.

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