Warehouse

Temperature and humidity monitoring

Temperature and humidity monitoring

OBJECTIVE 

The procedure of temperature and humidity monitoring in the storage and dispensing area.

SCOPE 

This SOP is applicable for monitoring temperature and humidity in the storage area/ dispensing area.

RESPONSIBILITY 

Warehouse personnel shall be responsible to follow the procedure mentioned in this SOP.

ACCOUNTABILITY 

Warehouse In-Charge   and QA Head shall be accountable for the compliance of the procedure mentioned in this SOP

ATTACHMENTS 

Temperature and humidity limits for Warehouse areas

Temperature and humidity monitoring record

PROCEDURE 

Digital hygrometers are placed in the areas where temperature and humidity have to be monitored.

Ensure that the hygrometers are calibrated.

Hygrometers are fixed to the point where the highest temperature is observed during the temperature mapping.

Record the observed temperature and humidity at the beginning of the day (8.00 – 9.00), in the afternoon (15.00 – 16.00), and in the evening (20.00 – 21.00) in Attachment -II.

Temperature and humidity parameters should be within an acceptable range (ref. Attachment I).

If the temperature rises up to 24.5°C, warehouse personnel should inform the engineering department that will take further action.

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Alvina

Alvina is the Author and founder of Guidelinepharma, she is a pharmaceutical professional having more than 20 years of rich experience in pharmaceutical field. During her career, she works in the quality assurance department with multinational companies i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, and Nectar life Science Ltd. During his experience, she faces many regulatorily audits i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda, Kenya, Tanzania, Zimbabwe. She is currently leading a regulatory pharmaceutical company as a Head Quality. You can join him by Email, Facebook, Google+, Twitter, and YouTube