Procedure for Temperature Mapping of Storage Areas
1) Purpose
The purpose of this SOP is to outline the procedure for conducting temperature mapping studies in storage areas to ensure uniformity and stability of temperature conditions for stored pharmaceutical products.
2) Scope
This SOP applies to all storage areas within the facility where pharmaceutical products are stored under controlled temperature conditions, requiring periodic temperature mapping to comply with regulatory requirements and internal specifications.
3) Responsibilities
Facility Engineering: Responsible for conducting temperature mapping studies.
Quality Assurance (QA) Department: Responsible for oversight and review of temperature mapping procedures and results.
4) Procedure
4.1 Study Planning:
4.1.1 Define study objectives, including identification of critical storage areas and temperature ranges.
4.1.2 Develop a temperature mapping protocol outlining sampling points, duration of monitoring, and acceptance criteria.
4.2 Equipment Preparation:
4.2.1 Calibrate temperature monitoring devices (e.g., data loggers, thermocouples) before deployment.
4.2.2 Ensure adequate number of monitoring devices to cover all critical areas within the storage facility.
4.3 Temperature Mapping:
4.3.1 Place temperature monitoring devices at predefined locations within each storage area.
4.3.2 Monitor and record temperature data continuously over the specified mapping period.
4.3.3 Maintain environmental conditions (e.g., door openings, HVAC settings) as per normal operating procedures during mapping.
4.4 Data
4.4.1 Retrieve temperature data from monitoring devices and compile into a comprehensive dataset.
4.4.2 Analyze temperature distribution and uniformity across the storage areas.
4.4.3 Compare recorded temperatures against defined acceptance criteria and regulatory guidelines.
4.5 Reporting:
4.5.1 Prepare a Temperature 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 temperature 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
Temperature Mapping Report
Calibration Certificates for Temperature 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
