Monitoring of Stability Chambers

1.0 OBJECTIVE

To lay down the procedure for Monitoring of Stability Chambers in Analytical Research department.

2.0 SCOPE

This SOP is applicable for Monitoring of Stability Chambers in Company Name.

3.0 BACKGROUND

NIL

4.0 RESPONSIBILITY

4.1 QC-Chemist

4.2 QC-Executive

4.3 QC-Head          

5.0 PROCEDURE

5.1 Stability samples shall be stored in an appropriate chambers where temperature and relative humidity are controlled at 

A) 25 ±2°C & 60 ±5%RH (or) Appropriate conditions.

B) 30 ±2°C & 65± 5%RH (or) Appropriate conditions.

C) 40 ±2°C & 75 ±5%RH (or) Appropriate conditions.

D) 30 ±2°C & 75 ±5%RH (or) Appropriate conditions.

5.2 Monitoring of chambers:

5.2.1 Every day  analytical research personnel shall check 

A) Temperature and Relative Humidity of each chamber. 

B) Alarm logs of each chamber.

5.2.2 Analytical Research personnel shall take printouts of the Temp. and RH data of stability chambers. After checking the printouts, he / she shall put signature and date and shall get the documents reviewed by group leader or his designee. In case of holiday printouts shall be taken and reviewed on the next working day.

5.2.3 Printouts shall be taken by following the respective stability chamber SOP.

5.2.4 Printouts shall be filed in the respective files and shall be retained for one year.

5.2.5 In case of any abnormality, follow procedure as mentioned in 5.3 or 5.4 or 5.5 as applicable.

5.2.6 Monitoring details of Stability chambers shall be entered in the respective“ Log book for Chamber Monitoring” (Annexure-1).

5.3 Handling of Minor excursions

5.3.1 Minor excursions due to door opening and during sampling are acceptable as these will  not have any significant impact on stability study , but not exceeding 1 hour.

5.4  Handling of Moderate excursions

5.4.1 Moderate excursions are the abnormal excursions may be due to Malfunctioning or Mishandling of the equipment / instrument and can be rectified immediately, but not exceeding 24 hours.

5.4.2 If any Moderate excursions are observed, the same shall be informed immediately to Head Analytical Research through “Intimation of Abnormal Event” (Annexure-2).

Note: Abnormal events shall be recorded immediately upon observation.

5.4.3 The Head Analytical Research shall investigate the root cause and take necessary remedial measures. 

5.4.4 Head Analytical Research shall record the remedial measures taken in the “Intimation of Abnormal Event ”  (Annexure-2). The same shall be executed / verified by Analytical Research personnel to ensure completion of corrective action and re-setting the chamber to the original condition.

5.4.5  Numbering of “Intimation of Abnormal Event (s) :

5.4.5.1 Each  abnormal event shall be assigned with a specific number and the numbering  system shall be as follows: 

5.4.5.2 Analyst (or) Group leader shall allot number for abnormal event(s).

5.4.5.3 Abnormal event report number shall consist of 11 characters.

5.4.5.4 The first two characters are “AR” denoting Analytical Research.

5.4.5.5 Next two characters are “AE” denoting “ Abnormal Event”

5.4.5.6 Fifth character shall be “-“ (Dash).

5.4.5.7 The next two characters are numerical denoting the last two digits of current year. 

5.4.5.8 The  next character shall be “-“ (Dash) 

5.4.5.9 The next three characters are numerical indicating the serial numbers.

5.4.5.10 The first report in the year 2015 shall have the following number “ARAE-15-001”.

5.4.6 Intimation of abnormal event should be entered in “Register for Abnormal Event”. (Annexure-3).

5.5 Handling of major excursions

5.5.1 Major excursions may occur due to failure of the equipment / instrument which exceeds defined tolerance for more than 24 hours.

5.5.2 All the major excursions shall be investigated through Incident investigation procedure as per SOP “Reporting, investigating and Disposing of incidents and deviations” and its impact on stability study shall be assessed.

5.5.3 The Analytical Research personnel shall initiate the “Incident Report”.    

5.5.4 Analytical Research personnel shall assess the impact of the major excursions on Stability study.

5.5.5 During assessment of impact on stability study, Analytical Research personnel shall review Mean Kinetic Temperature for the previous one year period for long term and intermediate stability study, and previous six months for Accelerated stability study.

5.5.6 In case the temperature condition during excursion period is substantially low for reasonable period of time, possibility of extending study period may also be considered. 

5.5.7 Based on the nature of the event, Incident shall be forwarded to Head-Analytical Research for event related investigation. 

5.5.8 Head Analytical Research shall provide his comments. The same report or in a separate page and in-turn shall forward the “Incident Report” to the Head-QA for disposition.

5.5.9 Head-QA, after disposition of the report, shall provide a copy to the Analytical department for filling with relevant documents.

6.0 REFERENCES

NIL

7.0 VERSION HISTORY

8.0 ANNEXURES