PHARMA DEVILS

QUALITY ASSURANCE DEPARTMENT

TEMPERATURE MAPPING PROTOCOL FOR FG STORE

TABLE OF CONTENTS

S.No. ITEM DESCRIPTION PAGE No.

1.0 PROTOCOL APPROVAL 2
2.0 OVERVIEW 3
2.1 Objective 3
2.2 Purpose 3
2.3 Scope 3
2.4 Responsibility 3-4
2.5 Execution Team 5
2.6 Risk analysis 6
3.0 PREREQUISITES 6
4.0 ACCEPETANCE CRITERIA 6
5.0 REVALIDATION CRITERIA 6
6.0 TEMPERATURE MAPPING PROCEDURE 7-8
7.0 DIAGRAM OF AREA SHOWING LOCATIONS 8
8.0 DATA LOGGER / SENSOR LOCATION NUMBER AND NAME 8
9.0 TEST INSTRUMENT CALIBRATION DETAILS 9
10.0 DISCREPANCIES AND CORRECTIVE ACTION TAKEN 10
11.0 LIST OF ANNEXURES 11
12.0 ABBREVATION SHEET 12
13.0 SUMMARY AND CONCLUSION 13
14.0 FINAL REPORT 14
 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

TEMPERATURE MAPPING PROTOCOL FOR FG STORE

1.0 PROTOCOL APPROVAL:

Signing of this approval page of Protocol indicates agreement with the validation approach described in this
document. If modification to the validation approach becomes necessary, an addendum shall be prepared
and approved. The protocol cannot be used for execution unless approved by the following authorities.
This protocol of Temperature/humidity mapping has been reviewed and approved by the following persons:

FUNCTION NAME DESIGNATION DEPARTMENT SIGNATURE DATE

PREPARED QUALITY
BY ASSURANCE
QUALITY
REVIEWED ASSURANCE
BY ENGINEERING
STORE
HEAD
APPROVED OPERATION
BY QUALITY
ASSURANCE
 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

TEMPERATURE MAPPING PROTOCOL FOR FG STORE

2.0 OVERVIEW:
2.1 Objective:
The objective of this protocol is to develop a plan for monitoring of temperature and humidity
of FG store area and to identify the minimum and maximum temperature and humidity
observed and also to identify the location for monitoring of temperature/humidity on daily basis
where the more fluctuation observed and also to demonstrate the reproducibility of the
temperature humidity in the area. The mapping shall be performed in line of WHO TRS 961.
2.2 Purpose:

The purpose of this protocol is to establish documentary evidence to ensure that the temperature
humidity inside the FG store area maintained & is suitable for storing the Finished goods.

2.3 Scope:

The protocol describes the procedure, documentation, acceptance criteria & revalidation criteria
to be used. This protocol shall be used for the mapping of FG store area.

2.4 Responsibility:

In accordance with protocol, following functions shall be responsible for the Temperature
humidity mapping of the FG store area.

Execution Team (Comprising members from Production, Engineering and Quality

Assurance) and their responsibilities are following:
 Prepares the temperature/humidity mapping protocol.

 Ensures that the protocol is in compliance with current policies and procedures on
system validation.
 Distributes the finalized protocol for review and approval signatures.
 Execution of protocol.

 Review of protocol, the completed data package and the final report.

 The data logger/sensor shall be placed by the Engineering Persons

 The printout of temperature/humidity mapping data shall be reviewed by production,

engineering and QA person.
 In case of any failure of Temperature/humidity observed the production person shall
inform to engineering and QA and engineering persons shall take corrective action.
 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

TEMPERATURE MAPPING PROTOCOL FOR FG STORE

Head – production/ Engineering:

 Review of protocol, the completed data package and the final report.

 Assist in the resolution of validation deficiencies.

Head – Operation / Quality Assurance:

 Review and Approval of protocol, the completed qualification data package and the final
report.
 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

TEMPERATURE MAPPING PROTOCOL FOR FG STORE

2.5 Execution Team:

The satisfactory mapping of the room shall be verified by executing the studies described in this
protocol. The successfully executed protocol document indicates that the Temperature/humidity
is maintained in the room throughout the mapping period.

Execution team is responsible for the execution of temperature mapping of room. All executors
involved with this protocol shall sign within the prescribed format given below:

NAME DEPARTMENT DESIGNATION SIGNATURE DATE

 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

TEMPERATURE MAPPING PROTOCOL FOR FG STORE

2.6 Risk analysis:

The FG store area was created for storing of the Finished goods. The product is not exposed in this
area and only stored after packing. As such the risk to product is low and if unfortunately
temperature/humidity is out of limit for longer time during storage may lead to product abnormality.
The risk analysis shall be carried out in line with HACCP tool as per the manual.

The risk hazard analysis and control point identified as per Annexure I.

The risk evaluation has been done as per Annexure II.

Conclusion of risk analysis:

All the risk related to FG store area temperature and humidity mapping and excursion evaluated by
HACCP tool (Hazard analysis and critical control point) and has been concluded that the risk which is
identified during analysis are found high but adequate control point in place.

3.0 PREREQUISITES:
 Calibrated data logger and sensors or wireless data logger.
 All Standard Operating Procedure shall be verified if any.
 All the measuring parameters shall be verified.

4.0 ACCEPTANCE CRITERIA:

The temperature and humidity in the room should be maintained throughout activity and should
be in between temperature 22± 3°C and humidity 40-60 %.

5.0 REVALIDATION CRITERIA:

 Change/Modification in FG store area

 Change in storage condition.
 Change/modification in HVAC system.
 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

TEMPERATURE MAPPING PROTOCOL FOR FG STORE

6.0 TEMPERATURE MAPPING PROCEDURE:
 AHU shall be in running condition upto the end of study and operate the HVAC system to get the
Temperature 22± 3 °C and humidity 40- 60 % in the area.
 Calibrated wireless data logger/sensor shall be used for temperature/humidity mapping process.
 The total area of FG store area is 191.700 m2. FG store area shall be divided in equal squares of 5
meter. At least one probe shall be kept in each square identifying the critical spot. Reason for
identifying the location shall be recorded. Place 8 numbers of temperature/humidity data
logger/sensor in room as per attached drawing and Table no.08. As per 5 meter criteria only 8 data
logger is required hence 8 data logger are considered for temperature mapping.
 Data logger/sensor shall be placed within 5 m of the area in the respective room.
 Risk analysis shall be performed for the number of sensor selected and placement of the sensor.
 The temperature/humidity data logger/sensor shall be placed at different working heights and at
different locations so as to get the data of actual temperature / humidity maintained throughout the
room. The data logger shall be placed in such a way that, the highest, lowest, middle stacking
height shall be covered.
 Switch on the data logger and check the working of data logger.
 Set the print interval time of mapping data i.e. 05 minutes.
 Start the mapping and check the data logger/sensor reading on daily basis twice in a day
frequency and same shall be recorded for continues Seven days and record the observation in
Annexure III.
 If temperature is beyond the acceptance limit, immediately rectify the situation and record in
discrepancy section and take corrective action.
 At the end of the study remove the data logger and note down the data logger ID from where data
logger removed in section No. 09.
 Stop the mapping on data logger and capture the data from data logger and identify the following
details.
 Note down the minimum, maximum and mean temperature/humidity.
 Decision to put the digital hygrometer for routine monitoring shall be taken on the location where
maximum fluctuation observed in room & hot Zone.
 Finally observed location shall be taken for the routine monitoring on the basis of temperature
 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

TEMPERATURE MAPPING PROTOCOL FOR FG STORE

mapping study and marking is to be done for identified location observed in room.

7.0 DIAGRAM OF AREA SHOWING THE LOCATIONS:

The diagram of the location of temperature/humidity mapping in the area.

8.0 DATA LOGGER / SENSOR LOCATION NUMBER AND NAME

Area name Location Location name Location height

No. from the floor (in
mm)
T1 Right side of entry door, Middle of wall/rack 2200
T2 Right side of entry door, Bottom of rack/wall 800
T3 Right side of entry door, Top of wall/rack 6000
T4 Right side of entry door, Middle of wall/rack 2800
FG store area
T5 In front wall/rack of entry door 3200
T6 Left side of entry door, bottom of wall/rack 600
T7 Left side of entry door, Middle of wall/rack 1500
T8 Hanging in the Middle of wall/rack 600
 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

TEMPERATURE MAPPING PROTOCOL FOR FG STORE

9.0 Test Instrument Calibration Details:
Location Channel Instrument ID Calibration Detail Instrument ID
No. / number No. (Before (After
Name mapping) Calibration Calibration Checked By Mapping)
Done on due on sign / Date
T1
T2
T3
T4
T5
T6
T7
T8
Data
NA
logger

Remarks: (If Any) ---------------------------------------------------------------------------------------------------------

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Reviewed By / Date:
 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

TEMPERATURE MAPPING PROTOCOL FOR FG STORE

10.0 DISCREPANCIES AND CORRECTIVE ACTION TAKEN:

Discrepancies:

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Corrective Action Taken:

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Deviation Accepted By: Deviation Approved By:

(Sign/Date) (Sign/Date)
 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

TEMPERATURE MAPPING PROTOCOL FOR FG STORE

11.0 LIST OF ANNEXURES:

Annexure No. Document Title

Remarks (if any):

_______________________________________________________________________________________

_____________________________________________________________________

______________________________________________________________________________

Done By & Date: Verified By & Date:

 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

TEMPERATURE MAPPING PROTOCOL FOR FG STORE

12.0 ABBREVIATIONS SHEET:
Following Abbreviations are used in the Temperature mapping protocol of Finished Goods Store Area
SR. No. ABBREVIATION DESCRIPTION

1. Sr. Serial

2. QAD Quality Assurance Department

3. MIS Miscellaneous

4. No. Number

5. °C Degree Centigrade

6. % RH Relative humidity

7. HVAC Heating ventilation and Air Conditioning

8. i.e. That Is

9. T Temperature

10. I.D. Identity

11. QA Quality Assurance

12. RM Raw material

 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

TEMPERATURE MAPPING PROTOCOL FOR FG STORE

13.0 SUMMARY & CONCLUSION:

SUMMARY:

CONCLUSION:

Prepared By (Sign/Date): Checked By (Sign/Date) :

 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

TEMPERATURE MAPPING PROTOCOL FOR FG STORE

14.0 FINAL REPORT APPROVAL:

It has been verified that mapping required for FG store area has been completed as per the predefined
protocol. The data required for this protocol completion has been attached to this protocol or included in the
qualification summary report. Verified that all amendments and discrepancies are documented, approved and
attached to this protocol.
Signature in the block below indicates that all items in this mapping report of FG store area has been
reviewed and found to be acceptable and that all variations or discrepancies have been satisfactorily
resolved.

FUNCTION NAME DESIGNATION DEPARTMENT SIGNATURE DATE

QUALITY
REVIEWED ASSURANCE
BY ENGINEERING
STORE
HEAD
APPROVED OPERATION
BY QUALITY
ASSURANCE
 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

TEMPERATURE MAPPING PROTOCOL FOR FG STORE

Annexure I
HAZARD ANALYSIS AND CRITICAL CONTROL PARAMETERS
Sr. PROCESS STEP HAZARD RISK CRITICAL JUSTIFICATION CORRECTIVE AND ESTABLISHMENT OF
No LIMIT/FREQUENCY PREVENTIVE ACTION VERIFICATION
1 Dispensed If temperature does not Low Specified limit is 22 ± 3 ° c / 50+ The temperature mapping is Personal entering into SOP of temperature
material hold area maintained in the area 5%.The frequency of monitoring carried out to check the Dispensed material hold monitoring is in place.
there is a possibilities of during mapping is 5 minutes for temperature area are well trained in Protocol based study for
degradation of product continuous Seven days. Routine accuracy/distribution avoid GMP practices. temperature mapping is
and hazard to the monitoring shall be performed at the degradation of the done.
patient. twice in a day frequency at the product.
position where fluctuation is more.

2 Man and material Possibilities of High Specified limit is 22 ± 3 ° c / 50+ Effect of routine operations Personal entering into SOP is in place for entry
movement excursion in 5%.The temperature mapping is done in the area with normal dispensed material hold and exit to dispensed
temperature may be performed for seven consecutive man and material movement area, are well trained in material hold area, Door
observed which may days with temperature logging at 5 shall be evaluated by using GMP practices. closure is available.
lead to the abnormality minutes frequency. online data logging system Training to be given for
of product stored. during mapping and same entry exit to new employee.
shall be verified during
routine monitoring. Door
closure is available.
3 Door opening and Possibilities of High Specified limit is 22 ± 3 ° c / 50+ Effect of routine operations Personal entering into SOP is in place for entry
closing excursion in 5%.The temperature mapping is done in the area with normal dispensed material hold and exit to dispensed
temperature may be performed for Seven consecutive man and material movement area, are well trained in material hold area. Door
observed which may days with temperature logging at 5 shall be evaluated by using GMP practices. closure is available.
lead to the abnormality minutes frequency. online data logging system Training to be given for
of product stored. during mapping and same entry exit to new employee.
shall be verified during
routine monitoring. Door
closure is available.
4 Breakdown of Breakdown of HVAC High Specified limit is 22 ± 3 ° c / 50+ In case of failure of HVAC The preventive Routine monitoring shall
HVAC may have direct impact 5%The temperature monitoring is due to continues running maintenance for HVAC be carried out twice in
on the temperature and performed at twice in a day temperature may increase. system shall be done for day. SOP for preventive
may not be maintained frequency. The temperature mapping proper functioning to be maintenance is in place.
in the area which may is performed for Seven consecutive maintained. The Diesel
lead to product days with temperature logging at 5 generator is provided if
abnormality. minutes frequency. power failure occurred.
 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

TEMPERATURE MAPPING PROTOCOL FOR FG STORE

Annexure I
HAZARD ANALYSIS AND CRITICAL CONTROL PARAMETERS
Sr. PROCESS STEP HAZARD RISK CRITICAL JUSTIFICATION CORRECTIVE AND ESTABLISHMENT OF
No LIMIT/FREQUENCY PREVENTIVE ACTION VERIFICATION
5 Sensor location Wrong selection of High Specified limit is 22 ± 3 ° c / 50+ The room shall be equally Correct placement of Approved protocol of
selection during sensor location would 5%.The frequency of monitoring divided within 5 m area and temperature sensors would temperature mapping and
mapping lead to faulty during mapping is 5 minutes for 8 number sensors shall be give the temperature drawing shall be prepared
temperature mapping consecutive Seven days and routine placed in the area at different mapping data which would prior to putting the sensor
result which would not monitoring shall be performed with height (minimum and be the representative of the on location and put the
be the representative of twice in day. maximum covering door room sensor as per the drawing.
the area. opening, middle of the room
and corners.
6 Faulty sensor/ Faulty sensor may gives High Specified limit is 22 ± 3 ° c / 50+ Before start of the activity The calibration of sensor The calibration of SOP is
Wrong sensor/ the faulty result 5%.The calibration of the data the calibration of data logger and data logger shall be in place for sensors and
Faulty data logger loggger shall be verified before start shall be verified. carried out as per data logger.
of the activity. predefined frequency
7 Sensor hanging in If wrong selection of Low Specified limit is 22 ± 3 ° c / 50+ The data logger shall be Correct placement of Sensor location diagram
middle sensor location then the 5%. hanged in middle which temperature sensors in the temperature mapping is in
result will not be The frequency of monitoring during select because the material is middle of the room would place and location is
representative the actual mapping is 5 minutes for continues kept in middle and which give the temperature marked on the drawing.
status dispensed Seven days. represent result of all area. mapping data which would
material hold area. be the representative of the
room.
8 Near door If wrong selection of High Specified limit is 22 ± 3 ° c / 50+ The data logger shall be Correct placement of Sensor location diagram
data logger location 5%. hanged near door which has temperature sensors near temperature mapping is in
then the result will not The frequency of monitoring during been selected because door the door would give the place and location is
be representative the mapping is 5 minutes for opening and closing temperature mapping data marked on the drawing.
actual status of consecutive Seven days. possibilities temperature which would be the
dispensed material increases into room and representative of the area.
holds area. maximum temperature is
observed at door location
9 All wall / racks of If wrong selection of Low Specified limit is 22 ± 3 ° c / 50+ This location is selected at Correct placement of Sensor location diagram
FG storage area data logger location 5%. specified height and on the temperature sensors at right temperature mapping is in
then the result will not The frequency of monitoring during wall / inside the racks so the and left side wall / racks of place and location is
be representative the mapping is 5 minutes for sensor shall represent the entry would give the marked on the drawing.
actual status of consecutive Seven days. condition of the room at temperature mapping data
dispensed material different location with which would be the
holds area. different height. representative of the area.
 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

TEMPERATURE MAPPING PROTOCOL FOR FG STORE

Annexure II
Risk evaluation for hazard identification

Process Step Occurrence Justification Severity Justification Risk matrix Risk Action plan
(O) (S) (O X S)
Dispensed 2 SOP of temperature monitoring is in 2 The temperature mapping is carried 4 Low Adequate measures are available to
material hold area place. out to check the temperature identify the critical control
Protocol of temperature mapping is in accuracy/distribution avoid the parameters in the system.
place. degradation of the product.
Man and material 5 Man and material movement is 1 The temperature mapping is carried 5 Low Adequate measures are available to
movement occurred for transfer of the material for out to check the temperature identify the critical control
several time during the day activity accuracy/distribution with various in parameters in the system. Door
hence the occurrence almost certain operation condition avoid the closure is available.
degradation of the product. Door
closure is available.
Door opening and 5 Door opening occurs several times for 1 Effect of routine operations done in 5 Low Automatic door closing system is in
closing transfer of the material. the area with normal man and place.
material movement shall be evaluated Control measures are adequate for
by using online data logging system monitoring of temperature at daily
during mapping and same shall be basis twice in day which easily
verified during routine monitoring. identify the excursion of temperature.
Door closure is available. Door closure is available.

Breakdown of 1 HVAC system has been installed to 4 All ready HVAC connection has been 4 Low In dispensed material hold area
HVAC control the temperature and relative provided in area to maintain the HVAC system has been provided and
humidity and also preventive desired temperature condition; additional preventive maintaince shall
maintenance is in place.. be in a place.
Selection of 1 The area is divided into equally and 4 Wrong selection of location may not 4 Low Proper distribution of sensor for
Sensor location sensor shall be placed at different provide actual status of all area. temperature mapping shall be verified
during mapping location with at different height as per the diagram.
If Faulty sensor/ 1 The activity shall be carried out by 4 Faulty data and wrong representation 4 Low Prior to start the activity calibration
Wrong sensor/ approved external vendor with of area shall be given by data logger. and working of data logger shall be
Faulty data logger calibrated data logger. verified.
 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

TEMPERATURE MAPPING PROTOCOL FOR FG STORE

Annexure III
1. CHECK LIST BEFORE STARTING OF TEMPERATURE MAPPING
Sr. No. Check point Verification status Verified by
1. Data logger/sensor calibration status
2. Data logger/sensor working
3. Data logger/sensor placed at defined
location as per drawing

2. *PHYSICAL VERIFICATION OF DATA LOGGER DURING TEMPERATURE MAPPING

Sr. Verified Verified

Date Morning Evening
No. by by
Location No. T1 T2 T3 T4 T5 T6 T7 T8 NA T1 T2 T3 T4 T5 T6 T7 T8 NA
Data logger
Code No./
Channel No.
1.
2.
3
4.
5.
6.
7.
8.
9.
10.

*Physical verification means position of data logger at right position, data logger location & display screen working. Put “√” if
found satisfactory & “X” if not satisfactory

Remark:
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Verified by sign/Date
 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

TEMPERATURE MAPPING PROTOCOL FOR FG STORE

Annexure IV
LAYOUT