Standard Operating Procedure for Ointment Filling System in Ocular Dosage Form Manufacturing
1) Purpose
The purpose of this SOP is to provide a standardized procedure for the operation, cleaning, and maintenance of the ointment filling system to ensure the consistent and sterile filling of ocular ointments.
2) Scope
This SOP applies to all ointment filling systems used in the manufacturing of ocular dosage forms, including ointments, within the pharmaceutical manufacturing facility.
3) Responsibilities
The responsibilities include the proper operation, monitoring, cleaning, and maintenance of the ointment filling system. Production personnel are responsible for operating the system and maintaining accurate records. Quality control personnel are responsible for verifying the filling process and ensuring compliance with SOPs.
4) Procedure
4.1 Preparation for Ointment Filling
- Ensure that the ointment filling area is clean, well-organized, and free from contaminants.
- Verify that all equipment, utensils, and materials needed for ointment filling are available and in good condition.
- Calibrate the ointment filling system according to the manufacturer’s instructions to ensure accurate filling volumes.
- Record the batch number, product name, and quantity of ointment to be filled in the batch production log.
4.2 Ointment Filling Process
- Preparation of Filling Equipment
- Assemble the filling system components as per the manufacturer’s instructions.
- Sanitize all parts that come into contact with the
- Load the prepared ointment into the hopper of the filling system.
- Start the filling system and begin filling the containers (tubes, jars, etc.) with the ointment.
- Monitor the filling process to ensure accurate and consistent filling volumes.
- Perform in-process checks for fill weight/volume at regular intervals.
- Once the containers are filled, proceed to seal or cap them according to the product specifications.
- Ensure that the sealing/capping equipment is properly set up and functioning.
- Inspect the sealed/capped containers for integrity and proper closure.
- Take samples of the filled ointment containers for quality control testing, including weight, fill volume, and sterility.
- Record the results of the quality control tests in the batch production log.
- If any parameters are out of specification, investigate and take corrective actions before proceeding.
- Label the filled and sealed containers with the batch number, product name, and other required information.
- Package the labeled containers according to the packaging SOP.
- Store the packaged containers in a designated area under controlled conditions.
4.3 Cleaning and Maintenance
- Clean the ointment filling system and all associated equipment thoroughly after each batch according to the cleaning SOP.
- Inspect the system for any signs of wear or damage and perform necessary maintenance or repairs.
- Record all cleaning and maintenance activities in the equipment logbook.
4.4 Documentation
- Record the details of the ointment filling process, including fill volumes, in-process checks, and quality control results, in the batch production log.
- Ensure that all records are signed and dated by the personnel responsible for the filling.
- Attach a copy of the batch production log to the batch production record for traceability.
4.5 Review and Approval
- The quality assurance department should regularly review filling procedures and records to ensure compliance with SOPs and regulatory requirements.
- Any discrepancies or deviations should be investigated, documented, and resolved promptly.
- Review and update the SOP as necessary to reflect any changes in procedures, regulations, or industry standards.
5) Abbreviations, if any
SOP: Standard Operating Procedure
CAPA: Corrective and Preventive Actions
6) Documents, if any
- Batch production log
- Batch production record
- Equipment logbook
7) Reference, if any
GMP Guidelines for Pharmaceutical Manufacturing
8) SOP Version
Version 1.0