Standard Operating Procedure for Storage and Handling of Lyophilized Products
1) Purpose
This SOP outlines the correct methods for storing and handling lyophilized products to preserve product stability and ensure compliance with regulatory standards.
2) Scope
This SOP applies to personnel responsible for the storage and handling of lyophilized products in warehouses, laboratories, and QA departments.
3) Responsibilities
- Warehouse Personnel: Responsible for ensuring lyophilized products are stored under the specified conditions to maintain stability.
- Laboratory Technicians: Responsible for handling lyophilized products during testing, reconstitution, and analysis.
- QA Personnel: Responsible for verifying that storage conditions meet regulatory guidelines and maintaining documentation.
4) Procedure
4.1 Storage Conditions
4.1.1 Temperature Requirements
- 4.1.1.1 Store lyophilized products in controlled environments based on product-specific storage requirements (e.g., 2-8°C or room temperature).
- 4.1.1.2 Monitor storage areas using calibrated temperature monitoring devices and ensure compliance with product specifications.
4.1.2 Humidity Control
- 4.1.2.1 Ensure that storage areas maintain low humidity levels to prevent moisture ingress, which could affect the stability of lyophilized products.
4.2 Handling Procedures
4.2.1 Inspection and Labeling
- 4.2.1.1 Inspect vials before handling, verifying proper sealing and checking for any signs of damage or contamination. Discard or quarantine compromised vials.
- 4.2.1.2 Ensure all products are labeled with appropriate storage conditions, batch number, and expiration date.
4.2.2 Transportation
- 4.2.2.1 Transport lyophilized
products using appropriate containers that maintain temperature and humidity control, preventing damage or contamination.
4.3 Documentation
All storage and handling activities must be documented in the Lyophilized Product Storage Logbook. Ensure that any deviations are reported and resolved, and that QA personnel verify all records.
5) Abbreviations
- QA: Quality Assurance
6) Documents
- Lyophilized Product Storage Logbook
7) References
- Pharmacopoeial guidelines for storage and handling of pharmaceutical 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 |