📌 Temperature and Humidity Validation/Mapping in Storage Area

Overview:
Temperature and humidity mapping is a critical activity in pharmaceutical warehouses, cold rooms, and storage areas to ensure that medicinal products are stored under controlled conditions as per regulatory requirements (e.g., ICH, WHO, FDA).

Key Points:

• Objective: To verify that the storage environment maintains required temperature (e.g., 15–25°C or 2–8°C for cold storage) and humidity ranges.

• Mapping Process: Placement of calibrated data loggers or sensors at multiple locations (corners, center, near doors, near HVAC vents) to capture variations.

• Duration: Typically conducted for 7–14 days, covering different operational scenarios (loaded/unloaded, summer/winter).

• Analysis: Identify hot spots, cold spots, and areas of high humidity.

• Validation Report: Includes methodology, results, deviations, acceptance criteria, and conclusion.

• Requalification: Performed periodically (e.g., annually) or when significant changes occur (e.g., relocation, modification of HVAC system).

Importance:

• Ensures product quality and stability.

• Complies with GDP (Good Distribution Practices).

• Provides regulatory evidence of controlled storage conditions.

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