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 is “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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