SOP for Temperature and Humidity Control in Stability Room

OBJECTIVE

To lay down a procedure for Temperature and humidity control in the Stability Room.

SCOPE

This procedure applies to the pharmaceutical manufacturing facilities of XYZ Limited.

RESPONSIBILITY

The Quality Control Chemist is responsible for the implementation of the process.

The Quality Control Manager is responsible for the execution of the procedure.

PROCEDURE

• On the rear side of the Stability room, a thermometer and hygrometer are along with a record sheet.
• A particular Q.C. staff is assigned the responsibility for daily recordings. In her/his absence the Q. C. Manager himself/herself shall do the recording.

• Daily at 2.00 pm the Humidity and Temperature shall be recorded.
• In the format, there should be a date, time, and signature of a person reading the temperature.

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• The Department in charge shall check daily the Temperature and Humidity records.
• The temperature of the stability room should be between 28oC-32oC; the Humidity should be maintained between 70% - 80%.
• If the authorized person finds any unusual deviation in reading he/she should immediately bring it to the notice of the Quality Control Manager.

REFERENCE

Nil.

ANNEXURE

Annexure: Temperature and humidity record

ABBREVIATION

SOP : Standard Operating Procedure

Q.A : Quality Assurance

No. : Number

Q.C : Quality control

% : Percentage

℃ : Degree centigrade

REVISION HISTORY

Nil

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