Standard Operating Procedure for Packaging Line for Inserts in Ocular Dosage Form Manufacturing

1) Purpose

The purpose of this SOP is to establish a standardized procedure for the operation, cleaning, and maintenance of the packaging line specifically designed for inserts, ensuring efficient and compliant packaging practices.

2) Scope

This SOP applies to the entire packaging line dedicated to inserts within the pharmaceutical manufacturing facility.

3) Responsibilities

Production personnel are responsible for operating the packaging line and ensuring that inserts are packaged securely and correctly. Maintenance personnel are responsible for cleaning, maintaining, and calibrating the packaging equipment.

4) Procedure

4.1 Preparation for Packaging

1. Ensure the packaging area is clean, organized, and free from contaminants.
2. Verify the availability and condition of all packaging materials, including inserts, pouches, labels, and cartons.
3. Set up the packaging line according to the product specifications and batch records.
4. Record the batch number, product name, and quantity of units to be packaged in the batch production log.

4.2 Packaging Line Operation

1. Setup and Calibration
   1. Perform initial setup and calibration of the packaging line to ensure proper alignment and settings.
   2. Load the packaging components (inserts, pouches, labels) into the line according to the batch record instructions.
2. Insert Packaging and Sealing
   1. Initiate the packaging and sealing process and monitor the line for proper operation.
   2. Verify each packaged insert for completeness and conformity to product specifications.
3. Labeling and Cartoning
   1. Transfer the packaged inserts to the labeling station and apply labels according to regulatory and batch requirements.
   2. Inspect labeled inserts for accuracy and adherence to labeling SOPs.
   3. Place labeled inserts into cartons and seal the cartons according to batch record instructions.

4.3 Quality Control Checks

1. Take samples of packaged units for quality control testing, including visual inspection and packaging integrity.
2. Record the results of quality control tests in the batch production log.
3. If any units fail quality control tests, investigate and take corrective actions before proceeding.

4.4 Cleaning and Maintenance

1. Clean the packaging line and all associated equipment thoroughly after each batch according to the cleaning SOP.
2. Perform routine maintenance checks and ensure all parts are properly maintained and calibrated.
3. Document all cleaning and maintenance activities in the equipment logbook.

4.5 Documentation

1. Record the details of the packaging line operation, including settings, in-process checks, and quality control results, in the batch production log.
2. Ensure all records are signed and dated by the personnel responsible for the packaging operation.
3. Attach a copy of the batch production log to the batch production record for traceability.

4.6 Review and Approval

1. The quality assurance department should review packaging procedures and records periodically to ensure compliance with SOPs and regulatory requirements.
2. Any discrepancies or deviations should be investigated, documented, and resolved promptly.
3. Review and update the SOP as necessary to reflect changes in procedures, regulations, or industry standards.

5) Abbreviations, if any

SOP: Standard Operating Procedure

QC: Quality Control

6) Documents, if any

1. Batch production log
2. Batch production record
3. Equipment logbook

7) Reference, if any

GMP Guidelines for Pharmaceutical Manufacturing

8) SOP Version

Version 1.0