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 suppositories and labeling materials along with batch records.
2. Inspect the labeling unit for cleanliness and ensure proper functioning of labeling mechanisms, sensors, and controls.
3. Ensure all safety protocols are followed, including checking emergency stop mechanisms.

4.2 Labeling Process

1. Set up the labeling unit according to suppository size and label specifications.
2. Load suppositories into the labeling machine feeder.
3. Initiate the labeling process and monitor for correct placement and adherence of labels.

4.3 Cleaning and Maintenance

1. After completing the labeling process, clean the unit thoroughly to remove any adhesive residues.
2. Inspect and lubricate labeling mechanisms and components 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