SOP for Conduct Temperature Mapping in Stores : Pharmaceutical Guidelines

SOP for Conduct Temperature Mapping in Stores

Standard operating procedure of temperature mapping in stores to identify the location of the worst point at which the thermometer and hygrometer for daily monitoring needs to be placed.

1.0 OBJECTIVE

To lay down a procedure for conduct a temperature mapping exercise in store.

2.0 SCOPE

This SOP shall be applicable to Cold Storage, Foil Store, BSR and R.M. Store where Raw Materials, Packing Material and Finished Products are stored under specified temperature conditions.

3.0 RESPONSIBILITY

Stores Person/ QA Person.

4.0 ACCOUNTABILITY

Head of Department

5.0 PROCEDURE

5.1 Before starting Temp. Mapping activity, ensure that all respective air handling unit and cold storage should be “ON” for 24 hours, RM Stores seven days, BSR and Foil Store for three days.
5.2 Place 16 calibrated probes for RM Store, 8 calibrated probes for BSR and Foil Store and 6 calibrated probes for Cold Storage at different places as shown in schematic diagram in a respective area.
5.3 After appearing stable temperature, start the recording of temp. at every half hours for the respective area and respective days.
5.4 After completion of the activity, find out the hottest zone in the area and place the thermometer and hygrometer in the respective zone.
5.5 Record the daily monitoring of temperature and humidity as per the schedule in respective format.

6.0 ABBREVIATIONS

6.1 SOP – Standard operating procedure
6.2 RM – Raw material
6.3 PM – Packing material
6.4 QA – Quality assurance

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Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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