Temparature Mapping Protocol

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PROTOCOL FOR TEMPERATURE & RELATIVE HUMIDITY MAPPING

Protocol No. Page No. 1 of 8
PROTOCOL FOR TEMPERATURE AND RELATIVE

HUMIDITY MAPPING
Area Name

SR. NO. CONTENTS PAGE NO.
1.0 Protocol approval 3
2.0 Objective 4
3.0 Scope 4
4.0 Responsibility 4
5.0 Execution team 4
6.0 Remapping criteria 5
7.0 Acceptance criteria 5
8.0 Methodology 5
8.1 Selection of data logger 6
8.2 Determination data logger location 6
8.3 Mapping procedure 6-7
8.4 Evaluation of temperature mapping results 7
8.5 Example for mounting of data logger (diagram) 7
9.0 Documentation 8
10.0 Deficiency & corrective action 8
11.0 Summary & conclusion 8
12.0 Abbreviation 8
13.0 Revision history 8
14.0 Reference 8

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 following authorities.
This performance qualification protocol of temperature & relative humidity mapping has been reviewed
and approved by the following authorities:
FUNCTION NAME DEPARTMENT SIGNATURE DATE
PREPARED BY ENGINEERING
QUALITY
REVIEWED BY
ASSURANCE
REVIEWED BY WAREHOUSE
QUALITY
APPROVED BY
ASSURANCE

2.0 OBJECTIVE:
The objective of this protocol is to verify the uniform temperature and humidity distribution in the material
storage area of the warehouse within specified range (NMT 25˚C and RH NMT 60 %) 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: Engineering shall be responsible for preparation, review of protocol and
its execution.
4.2 Reviewing of protocol:
4.2.1 Quality Assurance 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 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 preparing the layout and area for the temperature
mapping study, coordination and & compilation of mapping data after study.
5.3 QA department shall be responsible for reviewing 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 within NMT 30°C & NMT 80 % RH.
7.2 The print interval for data logger should not be more than 5 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.
Table -1
Environmental Mapping study criteria

S.N. Area Name
condition Empty condition Loaded Condition Seasonal
Temperature- 10mapping
Days For
RM Staging and Amoxy
1 NMT 25˚C 7 days 10 days all three
store (Approved RM)
RH-NMT 60 % seasons
Temperature-
Quarantine and under
2 NMT 25˚C 7 days 10 days NA
test
RH-NMT 60 %
Temperature-
3 FG store 7 days 10 days NA
NMT 25˚C
Temperature-
4 Foil store NMT 25˚C 7 days 10 days NA
RH-NMT 60 %
Temperature-
5 Empty bottle store NMT 25˚C 7 days 10 days NA
RH-NMT 60 %
Under test
quarantine ,approved Temperature- 10 Days For
6 material, quarantine, NMT 25˚C 7 days 10 days all three
dried material RH-NMT 60 % seasons
quarantine
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 5 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 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:
PMIS : Protocol for miscellaneous item
13.0 Revision history:
Whenever protocol need to be revised, it shall be foll owed change control procedure and reason for revision shall be
maintained as per below table.
Sr. No. Protocol Number Detail of revision

01
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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PROTOCOL FOR TEMPERATURE & RELATIVE HUMIDITY MAPPING

PROTOCOL FOR TEMPERATURE AND RELATIVE

PROTOCOL FOR TEMPERATURE & RELATIVE HUMIDITY MAPPING

SR. NO. CONTENTS PAGE NO.

1.0 Protocol approval 3

5.0 Execution team 4

6.0 Remapping criteria 5

7.0 Acceptance criteria 5

8.1 Selection of data logger 6

8.2 Determination data logger location 6

8.3 Mapping procedure 6-7

8.4 Evaluation of temperature mapping results 7

8.5 Example for mounting of data logger (diagram) 7

10.0 Deficiency & corrective action 8

11.0 Summary & conclusion 8

13.0 Revision history 8

PROTOCOL FOR TEMPERATURE & RELATIVE HUMIDITY MAPPING

1.0 PROTOCOL APPROVAL:

FUNCTION NAME DEPARTMENT SIGNATURE DATE

PROTOCOL FOR TEMPERATURE & RELATIVE HUMIDITY MAPPING

PROTOCOL FOR TEMPERATURE & RELATIVE HUMIDITY MAPPING

6.0 Remapping Criteria:

Environmental Mapping study criteria

PROTOCOL FOR TEMPERATURE & RELATIVE HUMIDITY MAPPING

8.1 Selection of Data logger:

PROTOCOL FOR TEMPERATURE & RELATIVE HUMIDITY MAPPING

PROTOCOL FOR TEMPERATURE & RELATIVE HUMIDITY MAPPING

Diagram: Location for data logger

Sr. No. Protocol Number Detail of revision

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