NANOGEN DETAILS

Risk Assessment for Transportation System Validation

(Ref. No.: RA-XXX-XX dated XX-XXX-XX)

Team : [TBD]

Prepared by: TBD

Designation: TBD

Sign and date:

Approved by: TBD

Designation: TBD

Sign and date:

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1. Introduction

Control of storage and transpiration temperatures is essential in maintaining

the quality of medicines and in helping to protect patients from sub-standard
or ineffective medicines that may result from inadequate control.

Nanogen Biopharmaceuticals JSC (NNG), factory 2 unit has started it

operations to supply quality products commercially to local as well as
overseas markets since ______. At present following products are being
supplied from the site to local & various overseas markets like _______. The
company has a plan to register products to highly regulated markets like
Australia and EU countries etc. Hence it has been decided to carry out an
extended Risk Assessment for Transportation system validation for transfer of
quality products to the highly regulated markets.

2. Purpose and Scope of Document

The purpose and scope of the document is to carry out an extended Risk
Assessment for Transportation system validation for supply quality products
to the highly regulated markets.

The potential impacts will be assessed in terms of risk and likelihood and
criticality score assigned using the following table.
Risk

High 3 6 9
Medium 2 4 6
Low 1 2 3
Low Medium High
Likelihood 

The criticality score was used to prioritise the risks and the actions to address
them.

The actions assigned, responsibilities and timescales are given in the Risk
Assessment table and Action Plan for transportation system validation in
Section 4.

3. Risk Assessment Team:

TBD

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 4. Impact analysis Table : Risk Assessment for Transportation System Validation
Team : TBD

(H/M/L)Likelihood Rating
Risk Rating (H/M/L)

ResponsibilityAction
Measures Required
Threat Description

Additional Control
Criticality Score
Current Control

Implementation
Target Date for
Consequences
Measures

Potential
Sl. No.

1.  Damage of products
during transportation.
 Vehicles are hired from reputed transport  Loss of security of M L 2  Technical Terms of Supply Head of
service providers/ couriers. products. agreement with the market Quality
 Products are transported through vehicles  Product degradation. M L 2 QA to be signed.
with good conditions with  Rejection of  Logistic service agreement
expert/professional drivers. M L 2 between commercial &
shipment. Commercial As and when
 Loading/ unloading of products are done logistics service provider
 Revenue loss. M L 2 to be signed. Manager required.
by the trained staff.
 Loss of company  Proper training to be
 Fitness certificate of the vehicle is L L 1 Validation/
reputation. ensured for the personnel
checked. Compliance
responsible for transports Manager
 Products are shipped through reputed of logistics service
airlines. provider.

2.  Temperature excursion  A/C vans, a/c airline warehouse & a/c  Product degradation. M L 2  Transportation system
of the product during cargo planes are used for transportation of  Rejection of validation to be done as
transportation. products. shipment. M L 2 per Protocol addressing
issue of temperature
 Seasonal variation  Labelled storage requirements and  Revenue loss. L L 1 excursion & seasonal
(raining, hot & humid) associated warnings are provided in the variation.
may lead to damage of shippers. Validation/
 Different outside
products. Compliance
temperatures to be TBD 2020
Manager
considered during
transportation of products.
 Physical audit to be
conducted in the
warehouse of the carrier
(Vietnam Airlines etc.).

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 Measures RequiredAdditional Control

Target Date for Implementation

MeasuresCurrent Control

(H/M/L)Likelihood Rating
ConsequencesPotential

Risk Rating (H/M/L)

ResponsibilityAction
Threat Description

Criticality Score
Sl. No.

3.  Problem with  Data loggers are procured from reputed  Product degradation. M L 2  Relevant
temperature monitoring European source or equivalent. staff, contract people, Validation/ TBD 2020
devices (data loggers).  Rejection of L L 1 drivers to be trained on Compliance
 Data loggers are kept as par plan shipment. operating the data loggers. Manager
 Insufficient number of representing the worst case location/
data loggers in the  Revenue loss. L L 1
position, in a secured & safe way.  Data loggers representing
shippers and the total shipment to be
placement of shippers in  Calibrated data loggers are used to
monitor the temperature during storage & considered.
the carrier (e.g. plane,
lorry etc.) may not transportation of products.
represent the worst case
location/position.

4.  Theft or tampering  Products are kept under lock & key  Rejection of M L 2  Tamper Validation/ TBD 2020
during transportation. during transportation. shipment. evidence measures to be Compliance
 Revenue loss. L L 1 ensured in the sipping Manager
 Vehicles are hired from reputed transport boxes.
 Loss of company L L 1
service providers/ couriers.
reputation.
 Products are shipped through reputed
airlines.

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5.  Accidental mix up of  Labelled storage requirements and  Rejection of M L 2  Detail information of the Validation/ TBD 2020
product with other associated warnings are provided in the shipment. product to be provided in Compliance
food/chemical items shippers.  Revenue loss. L L 1 the shipping marks. Manager
while travelling for the  Logistic service agreement
airways warehouse.  Products are kept under lock & key  Loss of company L L 1 between commercial & Commercial As and when
during transportation. reputation. logistics service provider Manager required.
to be signed.
 Loading/ unloading of products are done
by the trained staff.  Proper training to be
ensured for the personnel Validation/ TBD 2020
responsible for transports Compliance
of logistics service Manager
provider.

Measures RequiredAdditional Control

Target Date for Implementation

MeasuresCurrent Control

(H/M/L)Likelihood Rating
ConsequencesPotential

Risk Rating (H/M/L)

ResponsibilityAction
DescriptionThreat

Criticality Score
Sl. No.

6.  Breakdown/ out of order  Vehicles are hired from reputed transport  Damage shippers, M L 2  Transportation system Validation/ TBD 2020
of vehicle. service providers/ couriers. cartons, blisters etc. validation to be done as Compliance
 Flight cancellation/  Products are transported through vehicles  Product degradation. L L 1 per SOP/ Protocol. Manager
delay leading to product with good conditions with  Rejection of  Different outside
lying in the airport in expert/professional drivers. L L 1 temperatures to be Commercial As and when
shipment. Manager required.
uncontrolled  Loading/ unloading of products are done considered during
temperature.  Revenue loss. L L 1 transportation of products.
by the trained staff.
 Loss of company  Proper shrink wrapping of
 Fitness certificate of the vehicle is L L 1 Commercial As and when
reputation. the product pallets with
checked. Manager required.
double poly propylene
 Products are shipped through reputed sheets/bags to be ensured.
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 airlines.  Physical audit to be
conducted in the Validation/ TBD 2020
warehouse of the airport/ Compliance
carrier (Vietnam Airlines Manager
etc.).

9.  Soiling/grounding of  Vehicles are hired from reputed transport  Damage shippers, M L 2  Shrink wrapping of the Production As and when
pallets with product service providers/ couriers. cartons, blisters etc. pallets with shippers to Manager required.
shippers without shrink  Products are shipped through reputed  Product degradation. L L 1 be done with double
wrapping may lead to airlines. propylene sheets/bags.
product damage by rain/  Rejection of L L 1
snow fall etc.  Loading/ unloading of products are done shipment.
by the trained staff.  Revenue loss. L L 1
 Loss of company
L L 1
reputation.

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4. Discussion & Conclusion:

From the above Risk Assessment for transportation system validation it can be
seen that there is insignificant risk on product quality with the existing control
measures to carry out the Transportation system validation for transfer of
finished products from factory primacies to the local as well as overseas markets.

Few additional control measures have been identified to eliminate any potential
risks involved for transportation system validation.

It can therefore be concluded that after implementation of the additional control

measures for validation of transportation system there will not be any product
quality risks for transport of products to the highly regulated markets.

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