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SOP for Recording of Temperature in Production Department

Standard operating procedure to record the temperature in Production area.
2024-04-17T12:10:58Z PrintOnline CoursesQuestion Forum 2 comments
✔ Technical Review by: | Last Verified:2024-04-17T12:10:58Z

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
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is a prominent Pharmaceutical Quality Assurance expert, consultant and the founder of Pharmaguideline. With over 22 years of hands-on experience in cGMP-compliant manufacturing environments, he specializes in establishing validation protocols, sterile area controls and data integrity systems. Ankur routinely interprets international regulatory frameworks (including FDA, EMA and ICH guidelines) to help global pharmaceutical professionals ensure strict regulatory compliance and operational excellence. Connect with Ankur on LinkedIn. Need Help: Ask Question

2 comments: Post Yours! Read Comment Policy ▼

  1. Ahmed Awad22 November

    I understood that Recording temperature is twice per working shift ; the first time is at shift start , while the second time is at shift "middle"

    Am I right ?

    ReplyDelete
  2. Anonymous23 March

    Yes. Shift twice if you use Hygrometer Device

    ReplyDelete

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