Standard Operating Procedure for Sealing 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 sealing line specifically designed for inserts, ensuring efficient and compliant production practices.
2) Scope
This SOP applies to the entire sealing line dedicated to inserts within the pharmaceutical manufacturing facility.
3) Responsibilities
Production personnel are responsible for operating the sealing line and ensuring that insert containers are sealed accurately and securely. Maintenance personnel are responsible for cleaning, maintaining, and calibrating the sealing equipment.
4) Procedure
4.1 Preparation for Sealing
- Ensure the sealing area is clean, organized, and free from contaminants.
- Verify the availability and condition of all materials, including containers, closures, and inserts.
- Set up the sealing line according to the product specifications and batch records.
- Record the batch number, product name, and quantity of units to be sealed in the batch production log.
4.2 Sealing Line Operation
- Setup and Calibration
- Perform initial setup and calibration of the sealing line to ensure accurate sealing parameters.
- Load the containers with inserts into the sealing line according to the batch record instructions.
- Sealing Process
- Initiate the sealing process and monitor the line for proper operation and seal integrity.
- Verify each sealed container
4.3 Quality Control Checks
- Take samples of sealed containers with inserts for quality control testing, including visual inspection and seal integrity verification.
- Record the results of quality control tests in the batch production log.
- If any containers with inserts fail quality control tests, investigate and take corrective actions before proceeding.
4.4 Cleaning and Maintenance
- Clean the sealing line and all associated equipment thoroughly after each batch according to the cleaning SOP.
- Perform routine maintenance checks and ensure all parts are properly maintained and calibrated.
- Document all cleaning and maintenance activities in the equipment logbook.
4.5 Documentation
- Record the details of the sealing line operation, including settings, in-process checks, and quality control results, in the batch production log.
- Ensure all records are signed and dated by the personnel responsible for the sealing operation.
- Attach a copy of the batch production log to the batch production record for traceability.
4.6 Review and Approval
- The quality assurance department should review sealing procedures and records periodically 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 changes in procedures, regulations, or industry standards.
5) Abbreviations, if any
SOP: Standard Operating Procedure
QC: Quality Control
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