SOP for Closing the Packaging Line During Tea and Lunch Breaks
Contents
In short: This is an example SOP for the checks packaging staff make before leaving a packaging line for a tea or lunch break: machines off, product and packs secured and identified, and the area left safe. It is for packaging operators and supervisors. It is an illustrative template; adapt it to your own quality system, line and products.
Why a break needs a procedure
A short stoppage is a real mix-up risk. Loose tablets, strips, cartons and printed material left on a conveyor or table can end up in the next pack, or in another batch, when work restarts. EU GMP Chapter 5 asks that attention be given to minimising mix-ups, substitutions and cross-contamination during packaging (paragraph 5.49), and that the product name and batch number are displayed at each packaging station or line (paragraph 5.51). US 21 CFR 211.130 requires physical or spatial separation from operations on other drug products to prevent mix-ups and cross-contamination (211.130(a)), and areas to be inspected before use to confirm that previous products and unsuitable materials were removed (211.130(e)).
The detailed break checks below are example in-house practice. Neither guideline prescribes a specific list for a tea or lunch break.
1. Objective
To lay down the procedure for closing the packaging line during tea and lunch breaks.
2. Scope
This SOP applies to packaging lines at the manufacturing facility of [site name] during tea and lunch breaks.
3. Responsibility
- Packaging personnel: carry out the checks in this SOP.
- Head Packaging: ensure the procedure is implemented effectively.
4. Procedure
The checks below apply to the strip pack or blister pack line and are carried out each time the line is stopped for a break.
- Make sure no product is left between the sealing rollers and that all packs are removed from the conveyor of the strip pack or blister pack machine.
- Check that the vibrator of the strip pack or blister pack machine is switched off.
- Check that the vacuum pump of the blister pack machine is switched off.
- Check that the defoiling machine is switched off and that defoiled tablets and scrap are covered with a polybag.
- Check that the conveyor belt is switched off.
- Keep good packs, rejected packs and loose packs in their own containers and label each container.
- Make sure all filled cartons are overprinted and weighed on the carton weighing balance or check weigher.
- Check that loose shippers are partly taped, so they are not mistaken for closed shippers.
- Switch off lights and the air handling unit (AHU) before closing the department, where the site’s AHU control philosophy allows it.
The product name and batch number remain displayed at the line during the break.
Where the line is stopped for longer than a break, or the product or batch changes, follow the site’s line clearance procedure instead (see EU GMP Chapter 5, paragraph 5.50).
Restart after the break
Before restarting, the operator confirms that the line and containers are as left, and that labels, cartons and leaflets on the line belong to the running batch. Any doubt is reported to the supervisor and QA.
5. Training
Trainer: Head Packaging or designee. Trainees: packaging and QA staff.
6. Distribution
Controlled copy 1: Head QA. Controlled copy 2: Head Packaging. Original copy: Head QA.
7. Annexures
Nil.
8. Abbreviations
| Abbreviation | Meaning |
|---|---|
| SOP | Standard operating procedure |
| AHU | Air handling unit |
| QA | Quality Assurance |
9. Revision history
| Sr. No. | Revision No. | Change control No. | Details of revision | Reason for revision |
|---|---|---|---|---|
| 1 | 00 | - | New SOP | New SOP |
Frequently asked questions
Is a full line clearance needed for a tea break? Usually not when the same product and batch resume, but the checks above secure the line. A line clearance is expected before a different product or batch starts.
Why are the packs in the containers labelled? Unlabelled good, rejected and loose packs are easy to mix up on restart. Labelling keeps them identifiable to the batch and status.
Why are partly taped shippers mentioned? A half-taped shipper is visibly open, so it is not mistaken for a completed, checked shipper.
See also: Handling of incidents and deviations, SOP for handling of power failure in plant and Good documentation practices for BMR, BPR and packaging instructions.
References
- European Commission, EudraLex Volume 4, EU GMP Part I, Chapter 5: Production, paragraphs 5.49 to 5.51 (packaging operations, line clearance, display of product name and batch number), in operation since 1 March 2015.
- US FDA, 21 CFR 211.130 (packaging and labeling operations), as in the eCFR.
Related articles
Guidelines on Packaging for Pharmaceutical Products (WHO TRS 902)
Plain-language summary of the WHO guidelines on packaging for pharmaceutical products: functions, materials, closures, labels, QA and packaging-line controls.
SOP for Sampling of Packing Material: Example with AQL Tables
Example SOP for sampling primary, secondary and tertiary packing material in QC: quarantine checks, sample size tables, AQL visual inspection and defect classes.
Oral Solid Dosage Manufacturing: Schedule M Controls
India's revised Schedule M covers controls for tablets and capsules, from powder handling and compression to coating, printing, blister packing and batch records.