Monitoring of Temperature, Relative humidity & Pressure differential in different area.

1.0.            OBJECTIVE:

To describe a systemic procedure for monitoring of Temperature, Relative Humidity & Pressure differential in different areas.

2.0.            SCOPE:

This procedure is applicable in each area where Product or Product material such as Raw material, Product bulk,  Semi-finish or Finish product is going to be exposed  or it’s storage to be done.

3.0.            RESPONSIBILITY:

3.1.           QA Officer / Executive shall be responsible for Issuance of the Temperature, Relative Humidity and Pressure Differential record(s); and review after completion of the month.

3.2.            Chemist / Officer of respective department shall be responsible to monitor, recording and submission of the Temperature, Relative Humidity and Pressure Differential records of their area(s).

3.3.            IP-QA Chemist / Officer shall be responsible for verification, collection and maintenance of the filled records of Temperature, Relative Humidity and Pressure Differential of the concern area(s).

3.4.            Engineering personnel shall be responsible to provide the environmental condition as required.  

3.5.            QA manager shall be responsible to ensure the monitoring activity as per GMP norms and approve the records.     

4.0.            PROCEDURE:

4.1.            Procedure for Temperature and % Relative Humidity Recording:

4.1.1.      Receive the Temperature and Relative Humidity Record from QA to record the temperature and Relative Humidity of the month and hang the format at the location which is selected to monitor the temperature and relative humidity.

4.1.2.      Ensure that the Digital thermometer is calibrated.

4.1.3.      Record the temperature and relative humidity in Annexure-I, after 20 minute of starting AHU and before starting any operation / activity in the area. Once the temperature and humidity are within acceptable range, start the production activity. Repeat record of temperature and humidity monitoring at every six hours interval throughout production activity.

4.1.4.      Temperature and Relative Humidity must be within the limit as maintained in Annexure-I. In case any deviation observed, then inform to Engineering department for maintenance of the system (AHU or Air condition) and also inform to QA.

4.1.5.      If the Area is under maintenance, then transfer the material / product to suitable storage condition and make an entry “Under Maintenance” with date and time in Annexure-I.

4.1.6.      Acceptance Criteria:

Temperature NMT 25c, Humidity NMT 55%,DP NMT 4 Pascal,Disp.booth 5to12mm of water.

4.2.            Procedure for Pressure Differential Recording:

4.2.1.      Ensure that the Magnehelic Gauges are calibrated.

4.2.2.      Record the pressure differential in Annexure-II after 20 minute of starting AHU and before starting any operation / activity in the area. Once the pressure differential is within acceptable range, start the production activity. Repeat record of pressure differential monitoring at every six hours interval throughout production activity.

4.2.3.      Pressure Differential must be within the limit . In case any deviation observed, then inform to Engineering department for maintenance of the system. And also inform to QA.

4.2.4.      If the Area is under maintenance, then transfer the material / product to suitable storage condition and make an entry “Under Maintenance” with time and date.

4.3.            Procedure for Submission / Issuance / Receiving of the record(s) / format(s) :

4.3.1.      At the last day of the month, manager of respective department shall review the Temperature and Relative Humidity and Pressure Differential record(s) and initials with sign and date.

4.3.2.      After review of record(s), Chemist / Officer of respective department shall be submitted the filled record(s) to QA department and receive new recording format of next month respectively with sign and date as per SOP-QA-001-01.

4.4.            Definition :

4.4.1.      Relative Humidity :

The ratio of actual water vapor of the air to the saturated water vapor pressure of the air at the same temperature expressed as a percentage. It is the ratio of the mass of moisture in the air, relative to the mass at 100% moisture saturation, at a given temperature.

4.5.            Reference :

4.5.1.      WHO guideline

5.0.            ANNEXUREURE:

Annexure-I      : Temperature and Relative Humidity Monitoring Record

Annexure-II    : Pressure Differential Monitoring Record

6.0.            REFERENCES:

NIL

7.0.            ABBREVIATION     :

Abbreviation used       Full form of abbreviation used

SOP                             Standard Operating Procedure

QA                              Quality Assurance

IP-QA                         In-process Quality Assurance

% RH                          Percent Relative Humidity

Hrs.                             Hours

AHU                           Air Handling Unit

WHO                          World Health Organization

8.0.            DISTRIBUTED TO:

Manufacturing

Warehouse

Quality assurance

Quality control

9.0.            REVISION HISTORY:

Revision No.	Change Control Number	Reason for the Modifications