Standard Operating Procedure for Storage Conditions of Transdermal Patches
1) Purpose
The purpose of this SOP is to define the procedures for storing transdermal patches to ensure they maintain their integrity, potency, and quality throughout their shelf life.
2) Scope
This SOP applies to the storage of all transdermal patches manufactured and stored within the facility, including raw materials, in-process materials, and finished products.
3) Responsibilities
The Warehouse Manager is responsible for ensuring the proper storage conditions of transdermal patches. All personnel involved in storage and handling must comply with this SOP.
4) Procedure
4.1 General Storage Requirements
- 4.1.1 Store transdermal patches in a clean, dry, and well-ventilated area.
- 4.1.2 Maintain storage areas free from pests, contaminants, and exposure to direct sunlight.
- 4.1.3 Segregate different types of products to avoid cross-contamination.
- 4.1.4 Ensure all storage shelves, racks, and pallets are clean and suitable for the storage of pharmaceutical products.
4.2 Temperature and Humidity Control
- 4.2.1 Store transdermal patches at controlled room temperature (15°C to 25°C) unless otherwise specified by the product label or manufacturer.
- 4.2.2 Monitor and record the temperature and humidity of the storage area daily using calibrated devices.
- 4.2.3 Maintain relative humidity (RH) between 30% and 65%.
- 4.2.4 If deviations occur, take corrective actions and document the incident.
4.3 Special
- 4.3.1 Some transdermal patches may require refrigeration or freezing. Store such products according to the manufacturer’s instructions.
- 4.3.2 Use temperature-controlled storage units (e.g., refrigerators, freezers) for products requiring specific temperature conditions.
- 4.3.3 Monitor and document the temperature of refrigerated and frozen storage units daily.
4.4 Handling and Transportation
- 4.4.1 Handle transdermal patches with care to avoid physical damage.
- 4.4.2 Use appropriate containers and packaging materials for transporting patches to maintain storage conditions during transit.
- 4.4.3 Verify that transport vehicles are suitable and maintain the required storage conditions during transit.
4.5 Inventory Management
- 4.5.1 Rotate stock using the First-In-First-Out (FIFO) principle to ensure older stock is used before new stock.
- 4.5.2 Perform regular inventory checks to ensure accurate stock levels and identify expired or damaged products.
- 4.5.3 Dispose of expired or damaged transdermal patches according to the facility’s waste disposal procedures.
4.6 Documentation
- 4.6.1 Record all storage conditions and monitoring data in the storage logbook.
- 4.6.2 Maintain records of temperature and humidity monitoring, corrective actions, and inventory checks.
- 4.6.3 Retain documentation as per regulatory requirements.
5) Abbreviations, if any
RH: Relative Humidity
FIFO: First-In-First-Out
6) Documents, if any
Storage Logbook
Temperature and Humidity Monitoring Records
Inventory Records
7) Reference, if any
ICH Q1A(R2): Stability Testing of New Drug Substances and Products
WHO Technical Report Series No. 992: Annex 5 – Stability Testing of Active Pharmaceutical Ingredients and Finished Pharmaceutical Products
8) SOP Version
Version 1.0
