SOP for Daily Temperature & RH Recording in Empty Capsule Storage Area

OBJECTIVE

To lay down a procedure for Daily temperature and R.H. recording in an empty capsule storage area.

SCOPE

This procedure applies for the Warehouse department in the Pharmaceutical Manufacturing Facilities of pharmaInfo Limited.

RESPONSIBILITY

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

The Warehouse in charge 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.& 4 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.

ALSO READ: SOP for Daily Temperature and RH Recording in Dispensing Area

• 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 15ºC to 25ºC.

• The humidity of the department to be maintained between 35% to 65%.
• If the authorized person finds 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

ºC : Degree centigrade

% : Percentage

ANNEXURE

Annexure No. – 1: Daily temperature and relative humidity record recording in empty capsule storage area

REVISION HISTORY

Nil

ALSO READ: SOP for Transfer and Receipt of Finished Goods From Production to Warehouse