Standard Operating Procedure for Liquid Filling Machine 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 liquid filling machine to ensure accurate and consistent filling of liquid ocular dosage forms.

2) Scope

This SOP applies to all liquid filling machines used in the manufacturing of ocular dosage forms within the pharmaceutical manufacturing facility.

3) Responsibilities

Production personnel are responsible for operating the liquid filling machine and ensuring the correct filling parameters are set and maintained. Quality control personnel are responsible for verifying the accuracy and integrity of filled liquid containers and compliance with SOPs.

4) Procedure

4.1 Preparation for Liquid Filling

1. Ensure the liquid filling area is clean, organized, and free from contaminants.
2. Verify the availability and condition of all equipment, tools, and materials needed for the filling process.
3. Set up the liquid filling machine according to the product specifications and batch records.
4. Record the batch number, product name, and quantity of liquid dosage forms to be filled in the batch production log.

4.2 Liquid Filling Process

1. Preparation of Liquid Filling Equipment
   1. Calibrate the liquid filling machine to ensure accurate volume dispensing.
   2. Prime the machine with the appropriate liquid formulation and adjust the filling parameters (speed, volume, etc.).
2. Filling Operation
   1. Load the containers (bottles, vials, etc.) into the liquid filling machine conveyor or fixture.
   2. Initiate the filling process and monitor the machine for proper operation.
   3. Verify the filled volumes and ensure accurate dispensing of the liquid dosage forms.
3. Quality Control Checks
   1. Take samples of filled liquid containers for quality control testing, including fill volume and visual inspection.
   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. Finalization and Storage
   1. Complete the liquid filling process and remove the filled containers from the machine.
   2. Label the filled containers with the batch number, product name, and other required information.
   3. Transfer the filled containers to the designated storage area under controlled conditions.

4.3 Cleaning and Maintenance

1. Clean the liquid filling machine 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.

4.4 Documentation

1. Record the details of the liquid filling process, including filling parameters, 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.

4.5 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