SOP for Temperature Recording in Raw and Packing Material and Finished Goods Stores
1.0 BJECTIVE:
To describe the procedure for Temperature recording in Raw and Packing material stores and Finished Goods Stores.
2.0 SCOPE:
This Standard Operating Procedure (SOP) covers the procedure for recording temperature by using thermo hygrometer in dispensing room & solvent room area, and recording of temperature by using data logger in controlled temperature room, RM ambient storage, PM ambient storage, finished goods store.
3.0 RESPONSIBILITY:
3.1 Store Personnel to follow the SOP
3.2 Store In-charge to ensure compliance
4.0 PROCEDURE:
4.1 Thermo hygrometers / data loggers are kept on its designated “Hot Point” at the respective areas except dispensing room.
4.1.1 Temperature recording in Dispensing Room.
4.1.2 Frequency: Prior to the start of dispensing activities.
4.1.3 Record the current temperature and humidity as displayed in thermo hygrometer in sequential logbook for dispensing as per Annexure II.
4.1.4 Limit of temperature in dispensing area during dispensing activity is not more than 300 C and limit of relative humidity is not more than 60% or as specified In respective BMR.(Batch Manufacturing Record)
4.1.5 If the temperature and humidity crosses the specified limit inform engineering department for rectification.
4.2 Temperature recording in controlled temperature room and finished goods Stores.
4.2.1 Frequency: daily between 13.00hrs to 14.00hrs. (on working days)
4.2.2 Limit of temperature in controlled temperature room and Finished Good Store is NMT25 Deg. C .
4.2.3 Record the current temperature as displayed in “Data logger”, in log book as per annexure –I.
4.2.4 In-case if temperature of controlled temperature room & finished goods stores exceeds 25 Deg. C for more than 48 hours, Inform maintenance department through QA department for corrective action.
4.3 Temperature recording in solvent room.
4.3.1 Frequency: daily between 13.00 hrs to 14.00 hrs. (on working days)
4.3.2 Record the current temperature as displayed in “Thermo hygrometer” in log book as per annexure-I
4.3.3 No temperature limit is specified for the area and recording done only for observation.
4.4 Temperature recording RM & PM ambient storage area.
4.4.1Temperature recording of this area is automatically recorded in data logger.
4.4.2 Take the printout of data logger every first week of the month as per current version of its SOP.
4.4.3 Data shall be reviewed and signed by the department person and keep Xerox copy of it in department and original to be submitted in Q.A. department for verification.
4.5 In-case if plant is shut down for more than 48 hours, inform maintenance department through QA department for recording temperature in holidays in controlled temperature and finished goods store.
4.6 Ensure the Thermo hygrometer / data logger in the respective areas is calibrated prior it’s calibration due date by maintenance personnel. During calibration period, separate calibrated hygrometer is issued by maintenance and shall be used for temperature and relative humidity recording.
Note: USP controlled Room Temperature excursion permitted to 15 – 30 Deg. C
5. ANNEXURE:
Annexure-I Temperature Record Log Book
Annexure-II Log book for dispensing of raw material