Procedure for Humidity Mapping of Storage Areas
1) Purpose
The purpose of this SOP is to outline the procedure for conducting humidity mapping studies in storage areas to ensure uniformity and stability of humidity conditions for stored pharmaceutical products.
2) Scope
This SOP applies to all storage areas within the facility where pharmaceutical products are stored under controlled humidity conditions, requiring periodic humidity mapping to comply with regulatory requirements and internal specifications.
3) Responsibilities
Facility Engineering: Responsible for conducting humidity mapping studies.
Quality Assurance (QA) Department: Responsible for oversight and review of humidity mapping procedures and results.
4) Procedure
4.1 Study Planning:
4.1.1 Define study objectives, including identification of critical storage areas and humidity ranges.
4.1.2 Develop a humidity mapping protocol outlining sampling points, duration of monitoring, and acceptance criteria.
4.2 Equipment Preparation:
4.2.1 Calibrate humidity monitoring devices (e.g., hygrometers) before deployment.
4.2.2 Ensure adequate number of monitoring devices to cover all critical areas within the storage facility.
4.3 Humidity Mapping:
4.3.1 Place humidity monitoring devices at predefined locations within each storage area.
4.3.2 Monitor and record humidity data continuously over the specified mapping period.
4.3.3 Maintain environmental conditions (e.g., HVAC settings) as per normal operating procedures during mapping.
4.4 Data Analysis:
4.4.1 Retrieve humidity
4.4.2 Analyze humidity distribution and uniformity across the storage areas.
4.4.3 Compare recorded humidity levels against defined acceptance criteria and regulatory guidelines.
4.5 Reporting:
4.5.1 Prepare a Humidity Mapping Report summarizing study objectives, methodology, findings, and conclusions.
4.5.2 Submit the report to QA for review and approval.
4.5.3 Retain records of all humidity mapping documentation in accordance with facility procedures and regulatory requirements.
5) Abbreviations, if any
QA: Quality Assurance
HVAC: Heating, Ventilation, and Air Conditioning
6) Documents, if any
Humidity Mapping Report
Calibration Certificates for Humidity Monitoring Devices
7) Reference, if any
ICH Q1A(R2) – Stability Testing of New Drug Substances and Products
FDA Guidance for Industry – Storage and Distribution of Drug Products
8) SOP Version
Version 1.0