Operation and Maintenance of Suppository Labeling Unit

1) Purpose

The purpose of this SOP is to outline the procedures for operating and maintaining the suppository labeling unit in the manufacturing process.

2) Scope

This SOP applies to all personnel involved in the operation, cleaning, and maintenance of the suppository labeling unit in the manufacturing facility.

3) Responsibilities

It is the responsibility of production operators, maintenance staff, and quality control personnel to follow this SOP to ensure proper operation and maintenance of the suppository labeling unit.

4) Procedure

4.1 Preparation

1. Verify the availability of labeled suppositories and batch records.
2. Inspect the labeling unit for cleanliness and ensure proper functioning of label dispensers, alignment controls, and barcode scanners.
3. Ensure all safety protocols are followed, including checking label stock and ink levels.

4.2 Labeling Process

1. Set up the labeling machine according to suppository size and label specifications.
2. Feed suppositories into the labeling unit and initiate the labeling process.
3. Monitor the labeling process to ensure accurate placement and adherence of labels.

4.3 Cleaning and Maintenance

1. After completing the labeling process, clean the labeling machine thoroughly to remove any adhesive residue.
2. Inspect and replace label dispensers and rollers as per maintenance schedule.
3. Document cleaning and maintenance activities in the logbook.

5) Abbreviations, if any

N/A

6) Documents, if any

Batch production record, Cleaning log, Suppository labeling unit specifications

7) Reference, if any

GMP guidelines, Manufacturer’s operating manual for suppository labeling unit

8) SOP Version

Version 1.0