Standard Operating Procedure for Storage of Finished Products
1) Purpose
The purpose of this SOP is to define the procedures for the proper storage of finished injection products to maintain their quality and integrity.
2) Scope
This SOP applies to all personnel involved in the storage of finished products at [Company Name] for intramuscular, subcutaneous, and intravenous injection products.
3) Responsibilities
The responsibilities of this SOP include:
– Warehouse Personnel: Handling and storing finished products according to the SOP.
– Quality Control (QC) Department: Monitoring storage conditions.
– Quality Assurance (QA) Department: Reviewing and approving storage procedures and records.
4) Procedure
4.1 Preparation for Storage
4.1.1 Ensure the storage area is clean, organized, and meets environmental requirements (e.g., temperature, humidity).
4.1.2 Verify that storage equipment (e.g., refrigerators, freezers) is functioning correctly and calibrated.
4.2 Storage of Finished Products
4.2.1 Store finished products in designated areas according to their storage requirements (e.g., temperature-controlled storage).
4.2.2 Ensure products are stored off the floor and away from walls to allow proper air circulation.
4.2.3 Label storage areas clearly to indicate the type and batch number of products stored.
4.3 Monitoring of Storage Conditions
4.3.1 Monitor and record storage conditions (e.g., temperature, humidity) at regular intervals.
4.3.2
4.3.3 Investigate and document any deviations from specified storage conditions and take corrective actions.
4.4 Inventory Management
4.4.1 Maintain an inventory log to track the quantity and location of stored finished products.
4.4.2 Conduct regular inventory checks to ensure accuracy and integrity of stored products.
4.5 Documentation
4.5.1 Maintain records of storage conditions, inventory logs, and any deviations or corrective actions.
4.5.2 Ensure all records are signed and dated by the responsible personnel.
5) Abbreviations, if any
– QA: Quality Assurance
– QC: Quality Control
6) Documents, if any
– Storage Condition Logs
– Inventory Logs
– Deviation Reports
7) Reference, if any
– Good Manufacturing Practices (GMP) Guidelines
– International Organization for Standardization (ISO) Standards
8) SOP Version
Version 1.0