Standard Operating Procedure for Filling Line for Ointments 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 filling line specifically designed for ointments, ensuring efficient and compliant production practices.

2) Scope

This SOP applies to the entire filling line dedicated to ointments within the pharmaceutical manufacturing facility.

3) Responsibilities

Production personnel are responsible for operating the filling line and ensuring that ointments are filled accurately and securely. Maintenance personnel are responsible for cleaning, maintaining, and calibrating the filling equipment.

4) Procedure

4.1 Preparation for Filling

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

4.2 Filling Line Operation

1. Setup and Calibration
   1. Perform initial setup and calibration of the filling line to ensure accurate filling volumes and settings.
   2. Load the filling components (containers, closures) into the line according to the batch record instructions.
2. Filling Process
   1. Initiate the filling process and monitor the line for proper operation and fill volumes.
   2. Verify each filled container for accuracy and conformity to product specifications.
3. Capping and Sealing
   1. Transfer the filled containers to the capping station and apply closures according to regulatory and batch requirements.
   2. Inspect capped containers for proper closure and adherence to capping SOPs.

4.3 Quality Control Checks

1. Take samples of filled containers for quality control testing, including visual inspection and fill volume verification.
2. Record the results of quality control tests in the batch production log.
3. If any containers fail quality control tests, investigate and take corrective actions before proceeding.

4.4 Cleaning and Maintenance

1. Clean the filling 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 filling 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 filling 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 filling 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