Standard Operating Procedure for Temperature Mapping in Storage Areas
1) Purpose
The purpose of this Standard Operating Procedure (SOP) is to establish a procedure for conducting temperature mapping in storage areas where pharmaceutical products, including Intramuscular (IM) and Subcutaneous (SC) injections, are stored to ensure that the environmental conditions meet specified requirements.
2) Scope
This SOP applies to all personnel involved in the temperature mapping of storage areas within the pharmaceutical manufacturing facility. It covers the procedures for planning, executing, and documenting temperature mapping studies.
3) Responsibilities
– Quality Assurance (QA) Department: Responsible for overseeing the temperature mapping study and ensuring compliance with regulatory guidelines.
– Facilities Department: Assists with the setup and monitoring of temperature mapping equipment.
– Production Department: Provides access to storage areas for the temperature mapping study.
4) Procedure
4.1 Planning
4.1.1 Define the objectives and scope of the temperature mapping study, including the storage areas to be mapped and the duration of the study.
4.1.2 Develop a temperature mapping protocol detailing the equipment, placement of sensors, and data collection methods.
4.2 Equipment
4.2.1 Select appropriate temperature data loggers or sensors that are calibrated and capable of recording accurate temperature data.
4.2.2 Ensure that all equipment is calibrated
4.3 Setup
4.3.1 Place temperature sensors at strategic locations within the storage area, including near doors, windows, and areas with known temperature variability.
4.3.2 Ensure that sensors are placed at different heights to capture temperature variations throughout the storage area.
4.4 Data Collection
4.4.1 Initiate the temperature mapping study by starting the data loggers or sensors.
4.4.2 Collect temperature data continuously over the defined study period, ensuring that sensors remain undisturbed.
4.5 Data Analysis
4.5.1 Retrieve the temperature data from the loggers or sensors at the end of the study period.
4.5.2 Analyze the data to identify any temperature excursions or areas of concern.
4.6 Documentation
4.6.1 Document all temperature data, including raw data and any observations, in the temperature mapping logbook or electronic database.
4.6.2 Ensure that all records are reviewed and approved by the QA department.
4.7 Reporting
4.7.1 Prepare a temperature mapping report summarizing the methodology, results, and any deviations observed.
4.7.2 Submit the report to the QA department for review and approval.
4.8 Corrective Actions
4.8.1 If temperature excursions are identified, initiate an investigation to determine the root cause.
4.8.2 Implement corrective actions as necessary and document all findings and actions taken.
5) Abbreviations, if any
– IM: Intramuscular
– SC: Subcutaneous
– QA: Quality Assurance
6) Documents, if any
– Temperature Mapping Logbook
– Temperature Mapping Reports
– Calibration Records
7) Reference, if any
– WHO Technical Report Series, No. 961, 2011 – Annex 9: Model Guidance for the Storage and Transport of Time- and Temperature-Sensitive Pharmaceutical Products
– FDA Guidance for Industry: Control of Temperature and Humidity During Storage, Transportation, and Distribution of Drug Products
8) SOP Version
Version 1.0