Standard Operating Procedure for Storage Conditions for Finished Products
1) Purpose
The purpose of this SOP is to define the procedures for the storage of finished pharmaceutical products to maintain their integrity, stability, and quality throughout the storage period.
2) Scope
This SOP applies to all personnel involved in the storage and handling of finished products within the pharmaceutical manufacturing facility.
3) Responsibilities
3.1 Warehouse Personnel
- Store products according to specified conditions and requirements.
- Monitor storage conditions regularly.
3.2 Quality Assurance (QA) Personnel
- Verify storage conditions and conduct periodic inspections.
- Investigate and address any deviations from storage requirements.
4) Procedure
4.1 Storage Environment
- Designate storage areas based on product characteristics (e.g., temperature-sensitive).
- Ensure storage areas are clean, dry, and free from pests.
4.2 Storage Conditions
- Monitor and control temperature and humidity levels as per product specifications.
- Protect products from light exposure and other environmental factors.
4.3 Handling Procedures
- Use appropriate handling equipment and techniques to prevent damage.
- Follow FIFO (First In, First Out) method to minimize expired or obsolete stock.
4.4 Documentation and Recordkeeping
- Maintain accurate records of product storage conditions and monitoring activities.
- Document any deviations and corrective actions taken.
5) Abbreviations, if any
SOP: Standard Operating Procedure; QA: Quality Assurance; FIFO: First In, First Out
6) Documents, if any
- Storage Temperature and Humidity Logs
- Incident and Deviation Reports
- Product Inventory Records
7) Reference, if any
ICH Q1A (R2): Stability Testing of New Drug Substances and Products
USP General Chapter <1079>: Good Storage and Distribution Practices for Drug Products
8) SOP Version
Version 1.0