Standard Operating procedure on SOP on Temperature Mapping in RM, PM, FG, and Control sample Area
1.0 Objective: To Lay down the Procedure for Temperature Mapping in PM, RM, FG, and Control Sample area (Storage Area).
2.0 Scope: 2.1 This SOP shall apply to all storage areas in Pharmaceutical industries.
3.0 Reference: In –House
4.0 Responsibility:
4.1 RM, PM, and FG Store Supervisor to follow this SOP.
4.2 Executive-QA. to the issuance of this SOP.
4.3 Executive-Engineering is responsible for the Implementation of this procedure.
5.0 Accountability:
5.1 Head-Quality Assurance responsible for overall compliance with this SOP.
6.0 Procedure:
General Consideration: Enter the respective area and ensure that all doors of the respective area are tightly Closed. Ensure that the HVAC is in running condition.
6.1 Check the temperature & % relative humidity from different room locations during temperature mapping by an external agency.
6.2 Frequency of the temperature and humidity mapping in a storage area once a year.
6.3 Check the rooms to know the hot and cold spots. Then, place the humidity checker in the right place for regular checks.
6.4 The temperature check should cover all places where products are kept, either in three levels or in a zigzag way. Cover every spot where items are stored.
6.5 Cover the whole area.
6.6 Find the hottest spot for the data loggers/sensors for everyday use.
6.7 Use as many checkers as possible to get the best coverage.
6.8 Make sure to cover everything from top to bottom, left to right, and front to back.
6.9 Remember, spots near doors, walls, and ceilings might feel outside weather more.
6.10 Consider everything like doors, windows, air vents, and sunlight.
6.11 Keep the checkers less than 6 meters apart.
6.12 The check should last for at least 3 days (72 hours). Set the data loggers/sensors to record the temperature every hour.
6.13 Put data loggers/sensors where the temperature changes a lot. Record the highest and lowest temperatures.
6.14 Set the data loggers/sensors to record the temperature every hour for 72 hours.
6.15 Write down the data loggers/sensors details ID at the back. Also, mark where each checker should go.
6.16 Show where each data logger/sensor should go and give it an ID number.
6.17 Put the data loggers/sensors where you planned and write down when you start and stop.
6.18 When done, stop the data loggers/sensors and get the data. Print it out.
6.19 Attach the printed data and graphs to your report.
6.20 Check if the temperature is equally distributed using the graphs. Attach them to your report.
6.21 If any place is too hot or too cold, mark it. Ensure that no product is placed there.
6.22 The respective Dept. (RM, PM, FG & Control sample) Supervisor shall check the temperature, and %age of relative humidity of the area two times a day (or As per company Procedure).
6.23 The temperature and humidity shall be recorded as per “Monitoring of Temperature and RH SOP“.
7.0 Abbreviations:
SOP: Standard Operating Procedure
QA: Quality Assurance
PM: Packing material
RM: Raw material
FG: Finished goods
DEPT.: Department
-
by
-
