Any pharmaceutical good or product which, when not stored or transported within predefined environmental conditions or within pre-defined time limits, it might be degraded to the extent that it no longer performs as originally intended.
Here we describe how to carry out a systematic mapping procedure in any cold room, freezer rooms or other temperature-controlled store.
It does not cover mapping of small scale cold chain equipment such as refrigerators of freezers. Generally speaking
All new temperature-controlled storage areas must be temperature-mapped as part of a fully documented verification process, before taking in intended purpose. Subsequent mapping exercises must also be carried out on a periodic basis – for example, every three years.
Temperature mapping of storage area shall be recommended as per following…..
Data logger location:
Every 5 -10 meter in length while if height is 3.6 meter then three data logger shall be placed at floor level ,middle (1.2 meter) & top level (3 meter ).
Temperature mapping of storage area shall be recommended as per following…..
Data logger location:
Every 5 -10 meter in length while if height is 3.6 meter then three data logger shall be placed at floor level ,middle (1.2 meter) & top level (3 meter ).
If height is more than 3.6 meter (6 meter) then one data logger floor level, 1.8 meter, 3.6 meter & 5.4 meter.
Data logger logging time: 1- 15 minutes interval with sufficient memory for the intended study.
Data logger should be 3-point calibration certificate and have a guaranteed error of no more than ± 0.5°C at each calibration point.
Data logger should be 3-point calibration certificate and have a guaranteed error of no more than ± 0.5°C at each calibration point.
Mapping Periods:
It should be run for a minimum of 7 to 10 consecutive days for warehouses and other ambient storage areas in loaded condition, while in empty condition it should be minimum 24 hours.
Template for Temperature mapping protocols & Reports : download from below given link.
1.0 PROTOCOL APPROVAL:
Signing of this approval page of temperature & Relative humidity mapping Protocol indicates agreement with the temperature & relative humidity mapping approach described in this document. If modification to the temperature & relative humidity mapping approach becomes necessary, an addendum shall be prepared and approved. The temperature & relative mapping protocol cannot be used for execution unless approved by the authorities.
2.0 OBJECTIVE:
The objective of this protocol is to verify the uniform temperature and humidity distribution in the storage area within specified range in Empty condition, loaded condition and seasonal mapping.
3.0 SCOPE:
This protocol for the temperature & relative humidity mapping defines the procedural aspects to be followed while carrying out the monitoring which includes prerequisites. Also it defines the acceptance criteria, remapping criteria. This protocol is applicable for temperature & relative humidity in warehouse area at ………………..
4.0 Responsibility:
4.1 Preparation of Protocol: Quality assurance shall be responsible for preparation, review of protocol and its execution.
4.2 Reviewing of protocol:
4.2.1 Engineering department shall be responsible review of protocol and arrangement of external agency for mapping study and provide suitable services for temperature mapping.
4.2.3 Warehouse department shall be responsible for review of protocol and execution support.
4.3 Approval of Protocol:
Finally protocol shall be approved by head quality assurance unless protocol can’t be used for execution.
5.0 Execution Team:
5.1 Execution team shall be responsible for execution of protocol, execution team comprises of engineering, warehouse & quality assurance department.
5.2 Engineering department shall be responsible for arranging external agency for the temperature mapping study and coordinated for mapping data after study.
5.3 QA department shall be responsible for reviewing & compilation of mapping data.
6.0 Remapping Criteria:
Re-mapping shall be carried out whenever there shall be changes in:
6.1 Any major modification
6.2 Change in storage condition
6.3 Periodic re mapping shall be carried out once in three year.
7.0 Acceptance Criteria:
7.1 Temperature & % RH at all the selected locations should be as per requirements.
7.2 The print interval for data logger should not be more than 10 minutes.
7.3 Calibrated data logger shall be used for mapping.
8.0 Methodology:
Mapping study shall be carried out for the warehouse area mentioned as per table -1.
Before starting the temperature mapping in warehouse area following point shall be covered.
8.1 Selection of Data logger:
The calibrated data logger shall be selected for mapping study in warehouse area. Data logger must have three point calibrations. In general there should be one calibration point below the low end of the range, one calibration point in the middle of the range, and one calibration point above the high end of the range and each data logger should be annually calibrated. At the time of installation of data logger, all details shall be verified and calibration certificate and its traceability certificate shall be attached with report. However one type of data logger shall be used for mapping study.
8.2 Determination data logger location:
Mapping area shall be evaluated with respect to length, width & height and same shall be converted into drawing which shows arrangement of storage pallets.
Length and width: Data logger should be arranged in a grid fashion along the width and length of the area so that the area is reasonably covered, with data logger locations every 5-10 meters.
If mapping area is less than 5-10 meters then at least eight data logger shall be placed inside the area.
Height: At each point on the grid, arrange data loggers vertically as follow:
If the ceiling height is 3.6 meters or less, arrange data loggers directly above one another at high, middle and low level (e.g. one data logger at floor level, one at 1.2 meters and one at 3.0 meters height).
If the ceiling height is greater than the 3.6 meters, arrange data loggers in vertical arrays at the bottom, middle (multiple) and top of the space. For instance, for a storage area six meters in height, data loggers shall be placed in each grid location at heights of 0.3 meters (Bottom), 1.8 meters (Middle), 3.6 meters (Middle) and 5.4 meters (Top).
The details of data logger location with respect to identification number and mounting height shall be recorded in respective report.
8.3 Mapping procedure:
Ensure the recording interval of each device is the same and should be set between 10 minutes interval and its start time should be same.
Each data logger shall be mounted exactly as per location fixed in drawing. The position & fasten of the data loggers shall be in that manner so that they should not be damaged or displaced during the course of routine operations.
Ensure the air handling unit of the respective area is in running condition and all functional parameters like data loggers are function properly.
Temperature mapping of warehouse area for all three seasons at loaded condition mainly done in [summer (Apr. – Jun.), monsoon (Jul. – Sep.) & (winter (Oct. –Jan.)].
At the end of the study data logger shall be collected and data shall be down loaded and consolidate the data for study and minimum, maximum & average data shall be recorded in respective report of each area.
Hot and cold spot shall be verified for the routine monitoring of temperature and relative humidity.
8.4 Evaluation of temperature mapping results:
At the end of temperature mapping study temperature fluctuations shall be identified and minimum and maximum temperatures that occur in the mapped area during the study period shall be recorded in respective report.
8.5 Example for mounting of data logger:
Data logger shall be mounted as per below sketch diagram and isometric drawing with mounted data logger shall be attached with report.
Diagram: Location for data logger
Data logger
9.0 Documentation:
Separate report shall be prepared for warehouse area and the calibration status and mounting of data logger shall be recorded in space provided in respective report and calibration certificate with its traceability certificate shall be attached with respective report.
Separate report shall be prepared in case of remapping, with sub sequent report number.
10.0 Deficiency & corrective action
If any discrepancy observed during study same shall be recorded in space provided in respective report and same corrective action shall be taken in respective reports.
11.0 Summary & conclusion
Summary shall be written by hand in space provided in respective report minimum, maximum & average temperature data shall be tabulated and based on summary report conclusion shall be made in respective reports.
Based on summary & conclusion, report shall be approved by quality assurance head along with department head.
12.0 Abbreviation:
13.0 Revision history:
14.0 Reference
WHO Technical Report Series, No. 961, 2011, Annex 9: Model guidance for the storage and transport of time and temperature–sensitive pharmaceutical products. January 2014,
In house.
It should be run for a minimum of 7 to 10 consecutive days for warehouses and other ambient storage areas in loaded condition, while in empty condition it should be minimum 24 hours.
Template for Temperature mapping protocols & Reports : download from below given link.
1.0 PROTOCOL APPROVAL:
Signing of this approval page of temperature & Relative humidity mapping Protocol indicates agreement with the temperature & relative humidity mapping approach described in this document. If modification to the temperature & relative humidity mapping approach becomes necessary, an addendum shall be prepared and approved. The temperature & relative mapping protocol cannot be used for execution unless approved by the authorities.
2.0 OBJECTIVE:
The objective of this protocol is to verify the uniform temperature and humidity distribution in the storage area within specified range in Empty condition, loaded condition and seasonal mapping.
3.0 SCOPE:
This protocol for the temperature & relative humidity mapping defines the procedural aspects to be followed while carrying out the monitoring which includes prerequisites. Also it defines the acceptance criteria, remapping criteria. This protocol is applicable for temperature & relative humidity in warehouse area at ………………..
4.0 Responsibility:
4.1 Preparation of Protocol: Quality assurance shall be responsible for preparation, review of protocol and its execution.
4.2 Reviewing of protocol:
4.2.1 Engineering department shall be responsible review of protocol and arrangement of external agency for mapping study and provide suitable services for temperature mapping.
4.2.3 Warehouse department shall be responsible for review of protocol and execution support.
4.3 Approval of Protocol:
Finally protocol shall be approved by head quality assurance unless protocol can’t be used for execution.
5.0 Execution Team:
5.1 Execution team shall be responsible for execution of protocol, execution team comprises of engineering, warehouse & quality assurance department.
5.2 Engineering department shall be responsible for arranging external agency for the temperature mapping study and coordinated for mapping data after study.
5.3 QA department shall be responsible for reviewing & compilation of mapping data.
6.0 Remapping Criteria:
Re-mapping shall be carried out whenever there shall be changes in:
6.1 Any major modification
6.2 Change in storage condition
6.3 Periodic re mapping shall be carried out once in three year.
7.0 Acceptance Criteria:
7.1 Temperature & % RH at all the selected locations should be as per requirements.
7.2 The print interval for data logger should not be more than 10 minutes.
7.3 Calibrated data logger shall be used for mapping.
8.0 Methodology:
Mapping study shall be carried out for the warehouse area mentioned as per table -1.
Before starting the temperature mapping in warehouse area following point shall be covered.
8.1 Selection of Data logger:
The calibrated data logger shall be selected for mapping study in warehouse area. Data logger must have three point calibrations. In general there should be one calibration point below the low end of the range, one calibration point in the middle of the range, and one calibration point above the high end of the range and each data logger should be annually calibrated. At the time of installation of data logger, all details shall be verified and calibration certificate and its traceability certificate shall be attached with report. However one type of data logger shall be used for mapping study.
8.2 Determination data logger location:
Mapping area shall be evaluated with respect to length, width & height and same shall be converted into drawing which shows arrangement of storage pallets.
Length and width: Data logger should be arranged in a grid fashion along the width and length of the area so that the area is reasonably covered, with data logger locations every 5-10 meters.
If mapping area is less than 5-10 meters then at least eight data logger shall be placed inside the area.
Height: At each point on the grid, arrange data loggers vertically as follow:
If the ceiling height is 3.6 meters or less, arrange data loggers directly above one another at high, middle and low level (e.g. one data logger at floor level, one at 1.2 meters and one at 3.0 meters height).
If the ceiling height is greater than the 3.6 meters, arrange data loggers in vertical arrays at the bottom, middle (multiple) and top of the space. For instance, for a storage area six meters in height, data loggers shall be placed in each grid location at heights of 0.3 meters (Bottom), 1.8 meters (Middle), 3.6 meters (Middle) and 5.4 meters (Top).
The details of data logger location with respect to identification number and mounting height shall be recorded in respective report.
8.3 Mapping procedure:
Ensure the recording interval of each device is the same and should be set between 10 minutes interval and its start time should be same.
Each data logger shall be mounted exactly as per location fixed in drawing. The position & fasten of the data loggers shall be in that manner so that they should not be damaged or displaced during the course of routine operations.
Ensure the air handling unit of the respective area is in running condition and all functional parameters like data loggers are function properly.
Temperature mapping of warehouse area for all three seasons at loaded condition mainly done in [summer (Apr. – Jun.), monsoon (Jul. – Sep.) & (winter (Oct. –Jan.)].
At the end of the study data logger shall be collected and data shall be down loaded and consolidate the data for study and minimum, maximum & average data shall be recorded in respective report of each area.
Hot and cold spot shall be verified for the routine monitoring of temperature and relative humidity.
8.4 Evaluation of temperature mapping results:
At the end of temperature mapping study temperature fluctuations shall be identified and minimum and maximum temperatures that occur in the mapped area during the study period shall be recorded in respective report.
8.5 Example for mounting of data logger:
Data logger shall be mounted as per below sketch diagram and isometric drawing with mounted data logger shall be attached with report.
Diagram: Location for data logger
Data logger
9.0 Documentation:
Separate report shall be prepared for warehouse area and the calibration status and mounting of data logger shall be recorded in space provided in respective report and calibration certificate with its traceability certificate shall be attached with respective report.
Separate report shall be prepared in case of remapping, with sub sequent report number.
10.0 Deficiency & corrective action
If any discrepancy observed during study same shall be recorded in space provided in respective report and same corrective action shall be taken in respective reports.
11.0 Summary & conclusion
Summary shall be written by hand in space provided in respective report minimum, maximum & average temperature data shall be tabulated and based on summary report conclusion shall be made in respective reports.
Based on summary & conclusion, report shall be approved by quality assurance head along with department head.
12.0 Abbreviation:
13.0 Revision history:
14.0 Reference
WHO Technical Report Series, No. 961, 2011, Annex 9: Model guidance for the storage and transport of time and temperature–sensitive pharmaceutical products. January 2014,
In house.
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