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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 empty capsule storage area.

SCOPE
This procedure applies for Warehouse department in Pharmaceutical Manufacturing Facilities of XYZ Limited.

RESPONSIBILITY
The Warehouse Supervisor is responsible for implementation of the process.
The Warehouse in-Charge has to ensure the compliance.

PROCEDURE
  • On the rear side of department, temperature indictor is 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.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 indictor.
  • In the Annexure-1 there should be 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 find unusual deviation in the readings he/she should immediately bring to the notice of the Department in charge

REFERENCE(s)
Nil.

ABBREVIATION(s)
Q.A : Quality Assurance
Q.C : Quality Control
SOP : Standard Operating Procedure
No. : Number
W.H : Warehouse
ºC : Degree centigrade
% : Percentage

ANNEXURE(s)
Annexure No. – 1 - Daily temperature and relative humidity record recording in empty capsule storage area

 
REVISION CARD
Nil

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