Standard Operating Procedure for Storage Tank
1) Purpose
The purpose of this SOP is to describe the procedure for the proper operation and maintenance of the Storage Tank used in the pharmaceutical manufacturing of otic dosage forms to ensure safe and efficient storage of materials.
2) Scope
This SOP applies to all personnel involved in the operation and maintenance of the Storage Tank in the pharmaceutical manufacturing facility.
3) Responsibilities
Operators: Responsible for correctly operating the Storage Tank as per this SOP.
Quality Control (QC) Personnel: Responsible for monitoring the quality of stored materials.
Maintenance Personnel: Responsible for maintaining the Storage Tank in proper working condition.
4) Procedure
4.1 Pre-operation Checks
4.1.1 Inspection
4.1.1.1 Inspect the Storage Tank for cleanliness and integrity before use.
4.1.1.2 Ensure that all valves, fittings, and connections are in good condition.
4.1.1.3 Verify that the tank is empty and properly labeled with contents and batch information.
4.1.2 Preparation
4.1.2.1 Clean and sanitize the Storage Tank and surrounding area.
4.1.2.2 Check and prepare for the receipt of materials into the tank.
4.1.2.3 Ensure that the tank is connected to utilities and ready for operation.
4.2 Material Receipt
4.2.1 Transfer Process
4.2.1.1 Receive materials into the Storage Tank according to approved procedures.
4.2.1.2 Record all incoming materials and batch information accurately.
4.2.1.3 Ensure proper sealing and labeling of the tank after material receipt.
4.2.2 Quality Checks
4.2.2.1 Perform visual inspection of materials upon receipt.
4.2.2.2 Sample materials for QC testing as per sampling plan.
4.2.2.3 Document all QC checks and results.
4.3 Post-operation
4.3.1 Maintenance
4.3.1.1 Regularly inspect and clean the Storage Tank.
4.3.1.2 Perform preventive maintenance tasks as recommended by the manufacturer.
4.3.1.3 Keep maintenance records and document any issues or repairs performed.
4.3.2 Material Issue
4.3.2.1 Issue materials from the Storage Tank as per production requirements.
4.3.2.2 Record all material issues and update inventory records.
4.3.2.3 Ensure proper resealing and labeling of the tank after material issue.
5) Abbreviations, if any
QC: Quality Control
SOP: Standard Operating Procedure
6) Documents, if any
Material receipt and issue records
Inventory logs for the Storage Tank
Calibration records for the tank
7) Reference, if any
Manufacturer’s manual for the Storage Tank
Pharmacopeial guidelines for pharmaceutical storage practices
8) SOP Version
Version 1.0
