Standard Operating Procedure for Storage Conditions of Aerosol Products
1) Purpose
The purpose of this SOP is to establish guidelines for the proper storage of aerosol products in the pharmaceutical industry. This ensures product stability, integrity, and compliance with regulatory requirements during storage.
2) Scope
This SOP applies to the warehouse and storage areas at [Company Name], responsible for storing aerosol products according to specified conditions and guidelines.
3) Responsibilities
Warehouse Manager: Oversees storage operations and ensures adherence to SOP.
Quality Assurance (QA) Personnel: Monitor storage conditions and conduct periodic checks.
Production Personnel: Ensure proper labeling and segregation of products.
4) Procedure
4.1 Storage Conditions:
4.1.1 Store aerosol products in designated storage areas with controlled temperature and humidity.
4.1.2 Ensure storage areas are clean, dry, and free from contaminants.
4.2 Labeling and Identification:
4.2.1 Label each stored batch with product details, batch number, and expiry date.
4.2.2 Maintain clear identification and segregation of different products.
4.3 Handling Procedures:
4.3.1 Handle aerosol products with care to prevent damage or leakage.
4.3.2 Follow procedures for handling hazardous materials if applicable.
4.4 Storage Monitoring:
4.4.1 Monitor storage conditions regularly using calibrated equipment (e.g., temperature loggers).
4.4.2 Record temperature and humidity data as per defined frequencies.
4.5 Security and Access Control:
4.5.1 Implement security measures to prevent unauthorized access to storage areas.
4.5.2 Restrict access to authorized personnel only.
4.6 Documentation:
4.6.1 Maintain records of storage conditions, including monitoring logs and temperature excursions.
4.6.2 Document any deviations from specified storage conditions and corrective actions taken.
5) Abbreviations, if any
SOP: Standard Operating Procedure
QA: Quality Assurance
6) Documents, if any
Storage Monitoring Logs
Temperature and Humidity Records
Batch Manufacturing Record (BMR)
7) Reference, if any
ICH Q1A: Stability Testing Guidelines
FDA Guidelines on Good Storage Practices
8) SOP Version
Version 1.0
