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: Operator3.2 Checking: Production Pharmacist & Above
4.0 ACCOUNTABILITY
HOD-Production / Assigned Designee5.0 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 Procedure6.2 Q.A.: Quality Assurance
6.3 HOD: Head of The Department
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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"
ReplyDeleteAm I right ?
Yes. Shift twice if you use Hygrometer Device
ReplyDelete