Standard Operating Procedure for Storage and Handling of Lyophilized Products
1) Purpose
This SOP outlines the procedure for the proper storage and handling of lyophilized products to ensure product stability, integrity, and compliance with regulatory requirements.
2) Scope
This SOP applies to all personnel responsible for the storage and handling of lyophilized products, including warehouse staff, laboratory technicians, and QA personnel.
3) Responsibilities
- Warehouse Personnel: Responsible for ensuring that lyophilized products are stored under specified conditions to maintain their stability.
- Laboratory Technicians: Responsible for handling lyophilized products during testing and reconstitution procedures.
- QA Personnel: Responsible for ensuring that storage and handling procedures comply with GMP and regulatory guidelines.
4) Procedure
4.1 Storage Conditions
4.1.1 Temperature Control
- 4.1.1.1 Store lyophilized products at the specified temperature range (e.g., 2-8°C, room temperature, or as specified in the product documentation) to maintain product stability.
- 4.1.1.2 Monitor storage areas with calibrated temperature monitoring devices to ensure consistent temperature conditions are maintained.
4.1.2 Humidity Control
- 4.1.2.1 Ensure the storage area is kept at low humidity to prevent moisture ingress, which could affect the integrity of lyophilized products.
4.2 Handling Procedures
4.2.1 Product Inspection
- 4.2.1.1 Inspect each lyophilized product vial for signs of damage, improper sealing, or discoloration before use or shipment.
- 4.2.1.2 Discard or quarantine
any product that shows signs of damage or contamination.
4.2.2 Transportation
- 4.2.2.1 Use appropriate containers to maintain temperature and protect the product from environmental factors during transport.
- 4.2.2.2 Label each container with handling instructions, including temperature requirements and fragility warnings.
4.3 Documentation
Record all storage and handling activities in the Lyophilized Product Storage Logbook, including any deviations from specified conditions. Ensure that all entries are reviewed and verified by QA personnel.
5) Abbreviations
- GMP: Good Manufacturing Practice
6) Documents
- Lyophilized Product Storage Logbook
7) References
- Pharmacopoeial guidelines for storage and handling of lyophilized products
8) SOP Version
Version 1.0
Annexure
Lyophilized Product Storage Logbook Template
| Date | Product Name | Batch No. | Storage Conditions | Temperature Monitoring | Operator Initials | QA Verification |
|---|---|---|---|---|---|---|
| DD/MM/YYYY | Product Name | Batch Number | Conditions (e.g., 2-8°C) | Pass/Fail | Operator Name | QA Initials |