SOP on Monitoring of Temperature and Relative humidity.

1.0 Objective:
To lay down a procedure for SOP on Monitoring of Temperature and Relative
humidity.

2.0 Scope:
This procedure is applicable to the Quality Control-Microbiology Laboratory      
.

3.0 Responsibility: 
3.1 Microbiologist/s.

3.2 Head-Microbiology.

4.0 Accountability:
4.1 Head-QA. 

5.0 Procedure:
5.1 Temperature and Relative humidity shall be observed with the help of calibrated 

        digital hygrometer. 

5.2 Temperature and Relative humidity shall be recorded once in a shift.

5.3 In case of sterility testing area,Temperature and Relative humidity shall be 

        recorded once in a day.

5.4 If the Temperature and Relative humidity exceeds the set limit, inform to 

        Engineering Department for rectification.

5.5 Record the temperature of controlled area of Microbiology laboratory as per 

        current version.

5.6 Maintain the Temperature and Relative humidity of sterility testing area of 

        Microbiology laboratory in the current version.

5.7 Calibration of hygrometer shall once in a year by external party.

6.0 Abbreviations:
6.1 SOP     - Standard Operating Procedures.

6.2 HOD - Head of Department. 

6.3 QA - Quality Assurance. 

6.4 API - Active Pharmaceutical Ingredient.

6.5 QC - Quality Control. 

6.6 MB - Microbiology.

6.7 %            - Percentage.

6.8 ºC           - Degree centigrade.