by 1.0 OBJECTIVE
To lay down a procedure for monitoring Temperature, Relative Humidity.
2.0 SCOPE
The SOP is applicable to monitoring the temperature & relative humidity in Production, and Warehouse department.
3.0 RESPONSIBILITY
Production Chemist : To follow the Procedure
Store Assistant : To follow the Procedure
QA Officer : To follow the Procedure
4.0 ACCOUNTABILITY
Head of Concerned Department : System Implementation
Head QA : Overall system compliance
5.0 Procedure
5.1 Check the calibration status of the Hygrometer.
5.2 Check the temperature and relative humidity displayed in the digital hygrometer or Dry & Wet Bulb Hygrometer.
5.3 Record the Temperature and Relative Humidity at starting of the shift + 30 min and after every 4 hours ± 30 minutes for production, warehouse till completion of the activity or end of shift Whichever is later.
5.4 Monitor the differential pressure of the areas by Magnehalic gauze
5.5 Refrigerator temperature is mapping by calibrated thermometer
6.0 TRAINING
Trainer : Head – Quality Assurance
Trainees : Staff of all the departments
7.0 DISTRIBUTION
Master Copy : Quality Assurance
Controlled Copy : Quality Assurance
Display Copy : Quality Assurance, Production & Warehouse (if Required)
8.0 ATTACHMENT
| Sr. No. | Annexure No. | Title | Format No. |
| 1 | NA | NA | NA |
9.0 REFERENCES
In-house
10.0 ABBREVIATION
| Abbreviation | Extended Form |
| EG | Engineering |
| SOP | Standard Operating Procedure |
| QA | Quality Assurance |
| WH | Warehouse |
| NA | Not Applicable |
| MB | Microbiology |
11.0 REVISION HISTORY OF CHANGE
| Sr. No. | Date | Revision Details | Revision No. |
| 1 | NA | New SOP | 00 |
