SOP for Temperature Mapping of Warehouse

PURPOSE

To lay down the procedure for temperature and humidity mapping of the warehouse and retained sample room.

SCOPE

This procedure is applicable for temperature and humidity mapping in the warehouse and retained sample room at PharmaInfo Limited.

RESPONSIBILITY

QA Personnel: 

• To prepare, review, and approve the temperature mapping protocol.

Warehouse Personnel

• To follow the procedure as outlined.
• Review the Temperature mapping protocol.

Warehouse/QA Manager

• To ensure compliance with and effective implementation of the laid down procedures.

DEFINITIONS

Temperature Mapping: Temperature mapping is the process of determining the temperature profile of a particular temperature-controlled environment or process such as a freezer, refrigerator, incubator, stability chamber, or warehouse by measuring multiple points in a defined area over a specified study duration.

PROCEDURE

• Before starting the Temperature Mapping activity, ensure that all respective air handling units and air conditioners should be “ON” for 24 hours.
• Temperature and humidity mapping is to be carried out using the calibrated data loggers.
• Identify positions and number the locations for temperature and humidity mapping such that it covers every corner and center of the room.
• The temperature mapping exercise for RM Stores is 7 days, PM Store, FG Store, Controlled sample room & Cool room are 3 days.
• Program the data loggers and set the print interval at 30 minutes.
• Start the mapping after stabilization of the displayed temperature and humidity.
• Place the data loggers at identified locations for RM Store, PM Store, FG Store, Controlled sample room, and Cool room. Leave the data loggers without any disturbance.
• After the mapping process is successful place the Thermohygrometer at the identified hottest point and perform daily temperature and humidity monitoring as per Area monitoring SOP.
• If there are major changes to the design of the warehouse full temperature mapping should be done.

• Temperature mapping should be done for 3 seasons as follows: December for the rain season, for winter mapping, and for summer.
• Temperature mapping shall always be done as per Annexure 1 temperature mapping protocol and thereafter temperature mapping report shall be compiled as per Annexure 2.

ANNEXURES

Annexure No. 1: Temperature mapping protocol

Annexure No. 2: Temperature mapping report

ABBREVIATIONS

SOP – Standard operating procedure

RM – Raw material

PM – Packing material

FG – Finished Goods

QA – Quality assurance

REVISION HISTORY

Nil

ALSO READ: Temperature Mapping in Pharmaceuticals