What a pharmaceutical label inspection must prove
A pharmaceutical label inspection has to prove three things: the required batch number and expiry are present, the barcode is not printed damaged, and regulatory text is not missing. Looking like the last roll is not enough. The exact items follow this job’s quality agreement.
A pharmaceutical label inspection has to prove three things: the required batch number and expiry are present, the barcode is not printed damaged, and the artwork is not missing regulatory text. Proving that it “looks like the last roll” is not enough. The exact items follow this job’s quality agreement.
Why it is judged this way
A little dirt on a decorative motif is not the same grade as a missing stroke in the batch number. The camera has to keep the regions apart: regulatory text and the barcode stay tight, and the background may be loose. A release record needs at least the work order, the roll number, and which template version was used.
What to compare
| What you see | Call it | Do not |
|---|---|---|
| A missing stroke in the batch number or the expiry | Cannot be released | Put it at the same grade as background dirt |
| The barcode quiet zone is occupied | Cannot be released | Let it pass because a handheld scanner still reads |
| A very small paper spot in the background | Follow the dirt table | Invent a millimetre number when there is no table |
Check at a job change or a new roll
- Before the roll is opened, confirm the batch-number rule matches this template version.
- Take a sample with a missing stroke in the batch number and confirm it alarms.
- The release record writes the work order, the roll number, and the template version.
