SOP For Recording Temperature and Humidity of Stability Chamber

1. OBJECTIVE:

The purpose of this SOP is to lay down a procedure for recording temperature and humidity of stability chamber.

2. SCOPE: 

This SOP is applicable Stability chambers in Quality Control Department at manufacturing facility.

3. RESPONSIBILITY:

1. Analyst / Section Head or his designee shall be responsible for follow the SOP.
2. The Head of Quality Control Department or his designee shall be responsible and implementation of the SOP.
3. PROCEDURE:
   1. Temperature and humidity monitoring of stability chamber shall be done through data logger with the software.
   2. The stability chamber shall be kept continuously ON for 24 hrs. The data logger will be used for daily 24 hours continuous reading.
   3. Record the Temperature and humidity from the controller and scanner every 10 minutes.
   4. Print out of temperature and humidity shall be taken on the daily basis at morning. The person who has taken the printout shall check and put his sign with date on print out. These printouts shall be verified by authorised person.
   5. In case of Holiday, the printout shall be taken on next working day.
   6. The excursions in temperature and humidity shall be reviewed.

4. Following criteria’s shall be considered while reviewing the spikes in the predefined temperature and RH conditions.
   1. Long Term Stability Chamber (25°C ± 2°C & 60% ± 5% RH) 
      1. If the temperature is out of range up to ± 2°C than the specified limit but it remain within ± 10°C not exceeding twenty four hour continuously.
      2. If the RH is out of range ± 5 % than the specified limit but remain within ± 10 % not exceeding twenty four hour continuously.
   2. Accelerated stability Chamber (40°C ± 2°C & 75% ± 5% RH)
      1. If the temperature is out of range up to ± 2°C than the specified limit but it remain within ± 10°C not exceeding twenty four hour continuously.
      2. If the RH is out of range ± 5 % than the specified limit but remain within ± 10 %    not exceeding twenty four hour continuously.
   3. Stability Chamber (30±2°C and 75%±5% RH)
      1. If the temperature is out of range up to ± 2°C than the specified limit but it remain within ± 10°C not exceeding twenty four hour continuously.
      2. If the RH is out of range ± 5 % than the specified limit but remain within ± 10 % not exceeding twenty four hour continuously.
5. The observed spikes as explained above in the set condition shall be considered acceptable and the reviewer shall sign off with comments.
6. In case, observed spikes or excursions are beyond as explained above, then deviation shall be initiated, the impact evaluation shall be jointly performed by QA and QC; however the mean kinetic temperature shall be evaluated immediately to evaluate any immediate action. The recommendations of joint investigation shall be duly documented and shall be given special emphasis while analyzing the next due station of all charged samples in the affected stability chambers.
7. In case of power failure, stability chambers shall run on generator. 
8. In case power failure due to government notification for no supply of power for a duration more than 12 hours or in case of  any major breakdown for a duration more than a day Stability in-charge shall raise a deviation stating the reason and list comprising details of samples and there age and shall forward it to Head QA.
9. Head-QA shall evaluate the lapse time (The duration in number of days during which period the samples under on-going stability study were exposed to ambient condition due to non-functioning of stability chamber). Depending on the lapse time, the Head QA shall recommend extension in stability program for number of days of lapse time plus one day as per their appropriate storage condition.
10. The amended stability calendar shall be followed for the remaining age of stability samples charged in the stability chambers affected due to power failure / major breakdown.   
11. In case of over shoot / under shoot of temperature or relative humidity, buzzer installed in stability chamber will alarmed. This will be immediately attended by Manager QC or designee. He will immediately intimate to engineering department for necessary corrective action.
12. In case of any breakdown in the normal functioning of stability chambers inform maintenance department to rectify immediately. Maintenance department shall contact the manufacturer of stability chamber if problem cannot be rectified by maintenance department.
13. Calibration of Stability Chamber shall be performed by the manufacturer of chamber or in-house, once in a year (± 01 month) or after major maintenance.
14. Manual Monitoring:
    1. In case any major breakdown/fault observed in the data logger, manual monitoring shall be done as below. 
    2. Manual monitoring of Temperature and Humidity of stability chamber shall be monitored and record in the format as Annexure – I.
    3. Record the temperature and Humidity of the stability chamber twice in a day at morning and at evening.
    4. Temperature and Humidity for the particular chamber shall be comply within the limit.
15. TRAINING:

Trainer : Head – Quality Control 

Trainees           : Quality Control chemist / Sectional Heads

6. DISTRIBUTION:

Controlled Copy No.1:  Head of Department – Quality Assurance

Controlled Copy No. 2:  Head of Department – Quality Control

Original Copy :  Head – Quality Assurance

7. ANNEXURE:

Annexure –I: Temperature and Humidity recording of Stability Chamber.

8. REFERENCES:

Nil

9. REVISION HISTORY:

Sr.No.	Revision No.	Change Control Number	Details of Revision	Reasons(s) for Revision
1	00	———–	New SOP	New SOP