REEFER TRUCK INSTALLATION / OPERATIONAL/ PERFORMANCE

TITLE:
QUALIFICATION PROTOCOL - SUMMER SEASON 2017
Protocol Number IOPQ-RFRT-xxx-xx-P Revision 0 Issued Date dd-mm-yyyy

COMPANY NAME: XXXXXX

SITE REEFER TRUCK # xxx
LOCATION: XXXXXXX

PROTOCOL PREPARED BY
NAME SIGNATURE DATE
Name:
Title: dd-mm-yyyy
Company: Vacker Global

PROTOCOL APPROVED BY
NAME SIGNATURE DATE
Name:
Title: dd-mm-yyyy
Company: Vacker Global

PROTOCOL APPROVAL & REVIEWED BY

NAME SIGNATURE DATE
Name:
Title:
Company:
Name:
Title:
Company
Name:
Title:
Company

CHANGE HISTORY

NAME REASON FOR CHANGE REVISION ISSUED DATE

(dd-mm-yyyy)

New document 0 dd-mm-yyyy

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 REEFER TRUCK INSTALLATION / OPERATIONAL/ PERFORMANCE
TITLE:
QUALIFICATION PROTOCOL - SUMMER SEASON 2017

Protocol Number IOPQ-RFRT-xxx-xx-P Revision 0 Issued Date dd-mm-yyyy

SCOPE OF THIS PROTOCOL :

Study type Temperature Mapping study & Qualification

Client name Xxxxxx

Asset Type REEFER TRUCK

Reefer Truck,
Description and Location Xxxx ,
Xxxx

Sl No. of the Asset Reefer trailer #

Low limit 2°C

Temperature range to be mapped
High limit 8°C

Duration of testing 3-4 days

Date of Testing 12th July 2017 to 15th July 2017

Reference Standards : This mapping study is carried out as per WHO Technical Report Series,
No. 961, 2011.

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 REEFER TRUCK INSTALLATION / OPERATIONAL/ PERFORMANCE
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QUALIFICATION PROTOCOL - SUMMER SEASON 2017

Protocol Number IOPQ-RFRT-xxx-xx-P Revision 0 Issued Date dd-mm-yyyy

TABLE of CONTENTS

1 IDENTIFICATION OF THE QUALIFICATION TEAM ................................................................... 4

2 DEFINITIONS AND ACRONYMS ................................................................................................. 5

3 SCOPE ........................................................................................................................................... 7

4 OBJECTIVE ................................................................................................................................... 7

5 RATIONALE .................................................................................................................................. 8

6 APPLICABILITY ............................................................................................................................ 9

7 RESPONSIBILITY ......................................................................................................................... 9

8 QUALIFICATION DOCUMENTATION ........................................................................................ 10

MANUAL ENTRIES IN PROTOCOL ................................................................................. 10
DEVIATION REPORTS ..................................................................................................... 10
DATA SHEETS .................................................................................................................. 10
8.3.1 IQ SECTION .......................................................................................................... 10
8.3.2 OQ SECTION ........................................................................................................ 11
8.3.3 PQ SECTION ........................................................................................................ 11
8.3.4 INSTALLATION / OPERATIONAL / PERFORMANCE QUALIFICATION REPORT ................ 12
CHANGE CONTROL ......................................................................................................... 12
ANALYSIS ......................................................................................................................... 13

9 EQUIPMENT INSTALLATION/OPERATION DESCRIPTION .................................................... 14

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 REEFER TRUCK INSTALLATION / OPERATIONAL/ PERFORMANCE
TITLE:
QUALIFICATION PROTOCOL - SUMMER SEASON 2017

Protocol Number IOPQ-RFRT-xxx-xx-P Revision 0 Issued Date dd-mm-yyyy

1 IDENTIFICATION OF THE QUALIFICATION TEAM

In order to identify the persons who have participated in the execution of this qualification, a specimen
of their signature and initial is shown below, beside their name and title.

Name Title Signature Initial

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QUALIFICATION PROTOCOL - SUMMER SEASON 2017

Protocol Number IOPQ-RFRT-xxx-xx-P Revision 0 Issued Date dd-mm-yyyy

2 DEFINITIONS AND ACRONYMS

In order to facilitate the comprehension of terms and acronyms used in this document, a brief technical
definition is shown below.
Terms Definitions
Equipment mostly used in conjunction with the equipment to be qualified but
Auxiliary Equipment
not included in the qualification package.
Change Parts Parts to fit different size / format or application.
Any major piece, part or assembly of the main equipment or sub-equipment
Component that does not have its own power supply and could not operate as a standalone
unit (valves, switches, etc.).
A device that interprets a mechanical, digital or analog signal, generated by a
Controller
sensor, to control an equipment or component.
A controller for which control have a direct impact on the quality of the product
Controller, critical
or proper operation of the equipment.
A controller for which control have no direct impact on the quality of the product
Controller, non-critical
or proper operation of the equipment.
For IQ: Any discrepancy between the installation specifications and the
actual (as found) installation.
Deviation
For OQ: Any discrepancy between the protocol and the actual performed test,
test function methodology, testing equipment, testing material etc.
A device that interprets a mechanical, digital or analog signal generated by a
Instrument sensor, and converts it into engineering units (°C, % RH, mA, etc.) through
scaling.
An instrument for which measurements have a direct impact on the quality of
Instrument, critical
the product or proper operation of the equipment.
An instrument for which measurements have no direct impact on the quality of
Instrument, non-critical
the product or proper operation of the equipment.
Parameters that must be maintained to process or produce products with
Key Operating
consistent quality attributes and those that may have an impact on the proper
Parameters
operation of the equipment.
Main Equipment Major equipment to be qualified.
A mechanical device (pressure switch, bimetal temperature switch, etc.), a
digital or analog transducer (limit switch, pressure sensor, temperature sensor,
Sensor
etc.) that generates an electrical or mechanical signal to an instrument or a
controller in order to be interpreted.
A sensor for which detection has a direct impact on the quality of the product
Sensor, critical
or proper operation of the equipment.
A sensor for which detection has no direct impact on the quality of the product
Sensor, non-critical
or proper operation of the equipment.
Piece of equipment, part of major equipment that possesses its own power
Sub-equipment
supply that could usually operates as a standalone unit (pump, conveyor etc.).
D Deviation
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TITLE:
QUALIFICATION PROTOCOL - SUMMER SEASON 2017

Protocol Number IOPQ-RFRT-xxx-xx-P Revision 0 Issued Date dd-mm-yyyy

Terms Definitions
ID Identification
IQ Installation Qualification
IOPQ Installation / Operational / Performance Qualification
N/Ap. Not Applicable
N/Av. Not Available
N/Sp. Not Specified
NIST National Institute of Standards and Technology
OQ Operational Qualification
PQ Performance Qualification
PM Preventive Maintenance
QA Quality Assurance
QC Quality Control
S/N Serial number
SOP Standard Operating Procedure
V.I.N. Vehicle Identification Number

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TITLE:
QUALIFICATION PROTOCOL - SUMMER SEASON 2017

Protocol Number IOPQ-RFRT-xxx-xx-P Revision 0 Issued Date dd-mm-yyyy

3 SCOPE
The Installation / Operational / Performance Qualification protocol is a comprehensive document, which
will be used to guide the executants, in the verification of the proper installation and operation of the
Reefer Truck ID located at Xxxx.

4 OBJECTIVE

The purpose of this Installation / Operational / Performance Qualification is to:

 Temperature mapping study to analyze distribution of temperature inside the Reefer Truck.

 Briefly describe the equipment, its major components and their roles.

 Verify that the Reefer Truck is properly installed according to the manufacturer and Xxxxxx
specifications thus permitting operation as per design specifications.

 Ensure that appropriate identification and documentation are in place.

 Ensure that the physical characteristics are compatible with planned equipment utilization.

 Ensure that appropriate operation procedures and training program are in place.

 Ensure that appropriate calibration (if necessary) and maintenance program are in place.

 Ensure that all features of the equipment described are functioning in the proper manner as
required to perform all operations associated with its use. Specific tests are designed to verify
that the equipment operates within all applicable design.

 Hot and Cold points of the Reefer Truck will be identified.

 Locations for placing sensors for continuous monitoring will be recommended based on the
hot and cold points.

 Number of data loggers are determined based on the volume of the Reefer Truck and as per
relevant WHO Standards.

Detailed technical information can be found in the technical documents supplied by the manufacturer
(refer to Section 12.1: Documentation for Installation).

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Protocol Number IOPQ-RFRT-xxx-xx-P Revision 0 Issued Date dd-mm-yyyy

5 RATIONALE

Installation / Operation/Performance Qualification is the establishment of documented evidence that the

equipment is installed in accordance with manufacturer's specification and consistently performs
according to design specifications and intended use.
The Installation / Operational /Performance Qualification protocol is designed to allow technical analysis
of all applicable installation requirements and operational functions. Proper installation and operation
will be established based on the following characteristics:
 Proper installation as per manufacturer and Xxxxxx specifications.
 Proper documentation, SOPs and calibration program.
 Verify the SOP for operation and maintenance.
 Proper operation of control panel keys as per manufacturer specifications.

 System Start-Up Verification

 Empty Reefer Truck Temperature Control and Distribution Verification
 Power Failure Verification in Empty Condition
 50% and 100% Loaded Reefer Truck Temperature Control and Distribution Verification
 Power Failure Verification in 50% and 100% Loaded Condition
 Door opening test in 50% and 100% loaded Test
All tests must be conducted by trained and experienced technical personnel and must be documented
in a scientific manner using this established format.
I M I N I temperature data loggers will be used to measure and record temperature. Each data logger has
been calibrated and calibration certificates, generated in the PDF report, will be placed in Supporting
Documents section. These electronic instruments are calibrated yearly and associated document will
be part of the report.
Any test function that does not have results which support the parameters defined in the approved
protocol must be conclusively rationalized for their deviation and approved or the qualification will be
considered invalid.
Note: We will use any equivalent data loggers with calibration certificate as per actual site conditions
and test schedule.

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Protocol Number IOPQ-RFRT-xxx-xx-P Revision 0 Issued Date dd-mm-yyyy

6 APPLICABILITY

All Vacker Global and Xxxxxx personnel, when performing the qualification of the Reefer Truck ID
shall follow this protocol.

7 RESPONSIBILITY
This qualification protocol must be respected by all Vacker Global and Xxxxxx employees during
processing.
The responsibility of the qualification of the Reefer Truck is attributed to the following:

Responsibilities
Task Vacker Global Xxxxxx
Make available all documentation required for the
qualification of the Reefer Truck. 
Collect information. 
Write the protocol. 
Review and approve the protocol.  
Verify that all critical instrument of the equipment have
calibrated valid date. 
Arrange loading and unloading of goods for the tests 
Coordinate activities.  
Execute the test described in the protocol. 
Compile and analyze data.  
Issue the final report. 

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8 QUALIFICATION DOCUMENTATION

MANUAL ENTRIES IN PROTOCOL

 All manual entries will be written in indelible blue ink.
 Any error must be crossed out with a single line stroke, and the correct information must be
entered below or above the error.
 All corrections must be initialed and dated.

DEVIATION REPORTS
Any discrepancy between the protocol and the actual performed test (test methodology, testing
equipment, testing material etc.) or failure of the application to meet the test function acceptance criteria
specified in the OQ section of this protocol must be documented on a Deviation and Corrective Action
Report form.
The Deviation Report numbers are to be indexed according to the section of the protocol to which they
pertain. For example, reports pertaining to OQ Test Verification in section 13.1 of this protocol will be
sequentially numbered D13.1-1, D13.1-2, etc.
All Deviation Reports associated with the execution of this protocol are to be enclosed in Attachment 1
of this protocol.

DATA SHEETS

8.3.1 IQ Section
Information pertaining to the Installation Qualification will be directly recorded in the IQ section of this
protocol. Here is a brief description of each section.

Section Description
Item that should be in place in order to satisfy the specified condition as stated by
Specified the manufacturer or regulation (if any). If no specified condition is stated by
manufacturer, then «Not specified» should be written in the corresponding field.
Item found at the time of qualification. Should meet or exceed the specified
As Found condition. If condition is not specified, «As Found» data will then be considered
for information purpose.
Indication that the item found is compliant with specifications or specified
conditions.
Pass / Fail - A «Pass» result indicates that the item is found compliant with specified condition.
- A «Fail» result indicates that the item is found not compliant with specified
condition and therefore will be reported as deviation.
Deviation Report
Reference to Deviation Report number (if applicable) pertaining to the test.
Number
Discussion of any unusual observations during the test or significant test conditions
Comments
not defined in the test procedure.
Documented by Signature and corresponding date for the person performing the test.
Signature and corresponding date for the person verifying the test data. .(By
Verified by
representatives from Vacker Global and Xxxxxx)

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8.3.2 OQ Section
Information pertaining to Operational Qualification will be directly recorded in the OQ Section «Test Data
Sheet» of this protocol. Here is a brief description of each section:

Section Description
Objective Define the purpose of the test.
Acceptance Criteria Description of the acceptance criteria.
Conditions, files, equipment, diagrams, tables. Any supporting documents or
Prerequisite equipment needed to execute the test, which are not obvious in the standard
operation of the equipment.
Description of the course of actions that need to be executed in order to produce
Methodology
the expected result.
Indication that the functionality tested is compliant with specifications.
- A «Pass» result indicates that the functionality tested is found compliant with
Pass / Fail specifications.
- A «Fail» results indicates that the functionality tested is found not compliant
with specifications and therefore will be reported as deviation.
Deviation Report
Reference to Deviation Report Number (if applicable) pertaining to the test.
Number
Discussion of any unusual observations during the test or significant test
Comments
conditions not defined in the test procedure.
Tested by Signature and corresponding date for the person performing the test.
Verified by Signature and corresponding date for the person verifying the test data.

8.3.3 PQ Section
Information pertaining to Performance Qualification will be directly recorded in the PQ Section «Test
Data Sheet» of this protocol. Here is a brief description of each section:

Section Description
Objective Define the purpose of the test.
Acceptance Criteria Description of the acceptance criteria.
Conditions, files, equipment, diagrams, tables. Any supporting documents or
Prerequisite equipment needed to execute the test, which are not obvious in the standard
operation of the equipment.
Description of the course of actions that need to be executed in order to produce
Methodology
the expected result.
Indication that the functionality tested is compliant with specifications.
- A «Pass» result indicates that the functionality tested is found compliant with
Pass / Fail specifications.
- A «Fail» results indicates that the functionality tested is found not compliant
with specifications and therefore will be reported as deviation.
Deviation Report
Reference to Deviation Report Number (if applicable) pertaining to the test.
Number

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Protocol Number IOPQ-RFRT-xxx-xx-P Revision 0 Issued Date dd-mm-yyyy

Discussion of any unusual observations during the test or significant test

Comments
conditions not defined in the test procedure.
Tested by Signature and corresponding date for the person performing the test.
Verified by Signature and corresponding date for the person verifying the test data.

8.3.4 Installation / Operational / Performance Qualification Report

The Installation / Operational / Performance Qualification report will be written following the execution
of the protocol and will include the sections listed below.

Section Description
Description of the objective of the Installation / Operational / Performance
Objective
Qualification.
Summary of the results of the execution of each major section of this protocol
Summary
including a summary of deviations (if any).
General conclusion for all verifications and observations indicating the
Conclusion
acceptability of the equipment for operation.

CHANGE CONTROL
Changes, upgrades and / or configuration modifications made to the equipment will be executed and
documented according to the current Xxxxxx Change control procedure (Change Control SOP). All
change control documents for the equipment qualified under this protocol are to be referenced in
Attachment 4 of this protocol.

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ANALYSIS

Mean Kinetic Temperature

Mean kinetic temperature (MKT) is a simplified way of expressing the overall effect
of temperature fluctuations. Mean Kinetic Temperature (MKT) is defined as the single calculated
temperature at which the total amount of degradation over a particular period is equal to the
sum of the individual degradations that would occur at various temperatures.
A single derived temperature that, if maintained over a defined period of time, affords the same
thermal challenge to a drug substance or drug product as would be experienced over a range
of both higher and lower temperatures for an equivalent defined period.
The mean kinetic temperature can be expressed as:

Where:

is the mean kinetic temperature in kelvins

is the activation energy (typically within 60–100 kJ·mol-1 for solids or liquids)
is the gas constant

to are the temperatures at each of the sample points in kelvins

to are time intervals at each of the sample points

When the temperature readings are taken at the same interval (i.e., = = = ), the
above equation is reduced to:

Where:
is the number of temperature sample points
Note: In this study MKT is not considered as an acceptance criteria. The acceptance criteria is
specified that all data loggers should remain within the specified limits.
Software;
MKT is calculated using our software which is freely available at http://bit.ly/MKT-calculation
The above page also explains the step by step method for calculation of MKT
Hot and Cold Points
Hot and cold points are identified by analyzing the individual value of all data loggers
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Protocol Number IOPQ-RFRT-xxx-xx-P Revision 0 Issued Date dd-mm-yyyy

9 EQUIPMENT INSTALLATION/OPERATION DESCRIPTION

The refrigerated Reefer Truck is designed to maintain product temperatures between 2°C to 8°C/15
to 25°C to meet Xxxxxx requirements.

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