SOP for Daily Temperature & Relative Humidity Recording in Manufacturing Area

OBJECTIVE

To lay down a procedure for daily temperature and R.H. recording in the manufacturing areas.

SCOPE

This procedure applies for the production department in the Pharmaceutical Manufacturing Facilities of XYZ Limited.

RESPONSIBILITY

The concerned staff is responsible for implementation of the process.

The In-Charge is responsible for the execution and compliance of the procedure.

PROCEDURE

• On the rear side of the department, the temperature indictor fixed along with record sheet.
• A particular person is assigned the responsibility by the Department in charge for the daily recording. In his/her absence the Department in-charge himself/herself shall do the recording.
• Daily at 9:00 A.M., 1:00 P.M. & 5:00 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.

• The format should include the date, time, temperature, humidity, and the signature of the recording person.
• The Department in charge shall daily check the temperature & humidity recording.
• The temperature of the room is to be maintained between 200C to 300C.
• The R.H. of the room is to be maintained between 40% to 60%.
• If the authorized person finds unusual deviations in the readings, he/ she should immediately bring them to the attention of the department in charge.

ABBREVIATION

Q.A: Quality Assurance

SOP: Standard Operating Procedure

No.: Number

℃: Degree Celsius

% : Percentage

ANNEXURE

Annexure No. - 01 -- Daily Temperature and R.H. monitoring record in the manufacturing area.

REVISION HISTORY

Nil

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