SOP for Daily Temperature and RH Recording in Dispensing Area

OBJECTIVE

To lay down a procedure for Daily temperature and R.H. recording in the dispensing area.

SCOPE

This procedure applies to the Warehouse department in the Pharmaceutical Manufacturing Facilities of XYZ Limited.

RESPONSIBILITY

The Warehouse supervisor is responsible for the implementation of the process.

The Warehouse in-Charge his designee has to ensure compliance.

PROCEDURE

• On the rear side of the department, the temperature indicator is fixed along with the record sheet.
• A particular person is assigned the responsibility by the Department in-charge of the daily recording. In his/her absence the Department in-charge himself/herself shall do the recording.

• Daily at 9.A.M.,1.P.M.& 5 P.M. the current temperatures & humidity, as shown in the Digital Hygro-thermometer, shall be correctly read and recorded in the format which is attached below the temperature & humidity indicator.

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• In Annexure-1 there should be a date, time, temperature, humidity, and the signature of the person recording.
• The Department in-charge shall check daily the temperature & humidity records.
• The temperature of the department to be maintained between 20℃ to 30℃.

• The humidity of the department to be maintained between 40% to 70%.
• If the authorized person finds an unusual deviation in the readings he/she should immediately bring to the notice of the Department in charge.

REFERENCE

Nil.

ABBREVIATION

Q.A: Quality Assurance

Q.C: Quality Control

SOP: Standard Operating Procedure

No. : Number

W.H: Warehouse

℃: Degree centigrade

% : Percentage

ANNEXURE

Annexure No.- 1 -- Daily temperature recording in the dispensing area

REVISION CARD

Nil

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