SOP for Recording of Temperature in Production Department : Pharmaceutical Guidelines

SOP for Recording of Temperature in Production Department

Standard operating procedure to record the temperature in Production area.

1.0  OBJECTIVE:

       To lay down a procedure for recording of Temperature in Production Department.

2.0  SCOPE:

       This SOP shall be applicable for recording Temperature in Production Department.

3.0  RESPONSIBILITY:

3.1  Execution              : Operator
3.2  Checking               : Production Pharmacist & Above

4.0  ACCOUNTABILITY:

       HOD-Production / Assigned Designee

5.0  PROCEDURE:

5.1  Production person shall ensure that all the AHU of the respective production area are “ON”.
5.2  Production person shall note down the temperature by using digital thermometer twice in a day.
5.3  Specific time for noting temperature shall be 8.00 to 9.30 am & 12.00 to 13.30.
5.4  If any abnormalities are observed during the recording, Production person shall inform to Production Head.
5.5  Production Head shall inform the observed abnormalities to HOD QA & QC, Unit Head and Engineering Head for further rectification and action.
NOTE: Temperature is important from the point of view of
·    To avoid degradation of products.
·    To avoid damage to hard gelatin capsule shells.
·    Ensure the thermometer / temperature indicator is calibrated.

6.0  ABBREVIATIONS:

6.1  SOP: Standard Operating Procedure
6.2  Q.A.: Quality Assurance
6.3  HOD: Head of The Department



Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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