TRANSPORTATION QUALIFICATION AND VALIDATION

in PHARMA SUPPLY CHAIN

Berty Argiyantari
PT. MOSTRANS GLOBAL DIGILOG
Table Of Content

1. Company Overview

2. Pharma Supply Chain

3. Transportation Qualification and Validation

4. Conclusion
1. Company Overview

Company Overview

4. Conclusion
ABOUT MOSTRANS
We are the PIONEER in the digital logistic total solution platform for healthcare ecosystem

MOSTRANS has been launched on 10.10.19

as the 1st B2B digital logistic total solution platform
in Indonesia to connect the healthcare supply chain eco-system

Integrated End-to-End Solution

1 2 3 Cargo 4 Software
Transportation Warehousing Consolidation as a Service
Services

Information sharing, visibility and data analytics

 MOSTRANS NETWORK
Mostrans provides
warehousing operations in Jakarta,
Medan and Surabaya to ensure the
customer can deliver the service meet
with requirements.

The Warehouse characteristic

• Dedicated or multi-user
• Cross-docking
2 Branches • Warehouse Management System
• Inventory Management
3 Warehousing • Order processing, management, and
fulfillment
1300+ drop-point • Delivery and return management
170+ cities
 QUALITY PROGRAM FOR LOGISTIC OPERATION
Operations
Validation and Qualification • SOP for shipping, handling temperature
• All Equipment are calibrated & qualified, SOP excursion, change management, Contingency
for Calibration, Qualification and Validation Plan
• Temperature traceability during the shipment
• Transportation Management System

Regulatory Compliance
• Comply to CDOB Vendor Development
• CDOB, Safety and Security Training

Maintenance Program Performance Management

• Regular maintenance for fleets • Key Performance Indicator &
Performance review

Personnel Program
• Training of CDOB and logistic operation
 THE TECHNOLOGY FEATURES
Command
Center

1 Online Ordering System

Order easily through our
4 Notification
Send early notification of
website shipment progress
Shipper
Dashboard

2 Visibility
Get e-2-e visibility to capture 5 e-POD
Instantly see the POD
the shipment transparency when available
for both location and
temperature

3 Real Time Information

sharing 6 e-Invoice
Get invoiced quicker for
Share the real time information better efficiency
Transporter to update shipment journey for
Delivery Dashboard
Notification
both location and temperature
1. Company Overview

Pharma Supply Chain

4. Conclusion
 PHARMA SUPPLY CHAIN

Manufacturers
& Shippers
Origin Origin-Destination
Forwarders & Air Carrier
Trucking Co’s.

Airport Airport
Ground Ground
Handlers Handlers Destination
Forwarders &
Trucking Co’s

• The pharmaceutical supply chain is often complex, involving

multiple stakeholders, including manufacturers, distributors,
transporters, and healthcare providers
Distributors Hospital End user
• To ensure compliance, it is essential for pharmaceutical supply chain
to maintain product quality from the raw material phase until final
delivery.
TRANSPORTATION ROLE IN PHARMA SUPPLY CHAIN

Transportation is a critical link in the Pharma supply chain

• Involve end-to-end product movement from manufacturing facilities to the end-users (patients)
• Ensure the specified temperature conditions are consistently maintained

Product safety

Product integrity Product efficacy Patient’s safety

Product quality

➢ Any deviations from the recommended storage conditions ➢ Compliance with the regulations is necessary to ensure
can lead to product degradation, loss of potency, and the products meet the required standards and are safe
potential harm to patients for patient use

Once lost, product’s potency cannot be reversed

PHARMACEUTICAL TRANSPORTATION CHALLANGES

Temperature Infrastructure and Data Monitoring and Competency and

Safety and Security
Variations/Excursions Equipment Traceability Awareness

Temperature excursions Inadequate Implementing real-time Inadequate training or Criminal activities pose
during transportation transportation temperature monitoring lack of awareness can risks in life-threatening
can lead to product infrastructure can lead and ensuring data lead to mishandling and consequences for
degradation or loss of to delays, damage, and traceability can be compromised product patients who receive
efficacy increased risk of challenging, particularly quality contaminated or
product quality in remote regions counterfeit medications
1. Company Overview

Transportation Qualification and Validation

4. Conclusion
TRANSPORTATION QUALIFICATION AND VALIDATION

This activity is an essential component of

Good Distribution Practice (GDP) and Validation Plan Validation Report
regulatory requirement

• Ensure the pharma products are transported Performance

User Requirements
under controlled conditions Qualification

Quality Risk Management / Design Review

Specification (URS)
(PQ)

Change and Configuration Management

• Ensure patient safety and maintain the
quality and efficacy pharma products
Functional & Operation
through out the supply chain Design Qualification
Specification (OQ)

System
Installation
Configuration
Qualification (IQ)
Specification

Implementation
(Configuration)
TRANSPORTATION QUALIFICATION
• Qualification is a process of testing and documenting that equipment used in the pharma transportation are
suitable and function correctly to maintain the required temperature conditions.
• This includes validating the performance of refrigeration units and temperature monitoring systems

The transportation qualification process typically includes:

1 2
Design Qualification (DQ)
Ensuring that the design of
the transportation system
and equipment meet the
necessary requirements
Installation Qualification
(IQ)
Verifying that the
transportation equipment is
installed correctly according
to the specifications
3 4
Operational Qualification
(OQ)
Testing the equipment and
transportation processes
under various operational
conditions to ensure they
perform as intended
5
Performance Qualification Qualification
(PQ) Report
Demonstrating that the Documenting the
transportation system qualification process,
consistently performs including procedures,
within the required results, and any deviations
temperature range during occur
simulated transport
conditions
TRANSPORTATION VALIDATION
Transportation validation is the process of evaluating and ensuring the transportation methods is carried out under the
controlled condition throughout the journey

The activity includes:

• Verifying that the products are protected from environmental factors, such as temperature excursions, humidify, light
exposure, vibration and physical damage during transit
• Monitoring and controlling the temperature throughout the transportation process to ensure it remains within the specified
range

The transportation validation process involves the following steps:

1 2
Risk Assessment Protocol Design
Identifying and evaluating Creating a validation
potential risks to product protocol that outlines the
quality and efficacy objectives, testing methods,
acceptance criteria, and
responsibilities for the
validation study
3 4 5
Performance Validation
Data Analysis
Qualification Report
Conducting tests using Collecting and analyzing Preparing a comprehensive
loaded containers under data from the validation report summarizing the
different environmental study to ensure that the validation process, results,
conditions to capture real- transportation methods and conclusions
world scenarios consistently meet the
specified temperature
requirements
KEY ASPECT FOR TRANSPORTATION VALIDATION
Temperature Control
• The required shipment condition is achieved through
the use of temperature monitoring devices, such as
data loggers or temperature indicators, and the
selection of appropriate packaging and insulation
materials
Environmental Monitoring
• The environmental monitoring (temperature
excursion/variation) help to identify and mitigate any
deviations that may impact product quality
• Environmental monitoring systems provide real-time
data to ensure that the specified conditions are
maintained and take prompt corrective actions if
deviations occur
Insulation
• The selection of proper and suitable insulation
should be meet industry standard to provide
adequate protection to maintain the desired the
quality during transit
Validation Protocol, Report &
Documentation
• Transport validation requires documentation and
well-defined protocols which outline the
methodology for testing, acceptance criteria, and
documentation requirements
• The rigorous documentation ensures traceability,
regulatory compliance, and provides evidence of
transport validation
 Digital Technology
01 in Transportation Operation
VISIBILITY &
.
INFORMATION
Provides VISIBILITY, REAL TIME
SHARING INFORMATION SHARING and DATA
MANGEMENT in a single dashboard

The movement of the vehicles

which is connected to the GPS and
02 mobile apps which captured and
shared in real time basis
DATA
MANAGEMENT The data can be used as
an indicator to improve efficiency
as it provides accurate and timely
information about end-to-end
shipment journey
SUCCESS FACTOR

• Qualified and Trained Personnel

• Robust Risk Assessment and Management
• Advanced Monitoring Technologies
• Collaboration and Communication
• Continuous Improvement
CONCLUSION

The pharmaceutical supply chain is often complex, involving multiple stakeholders, including
1
manufacturers, distributors, transporters, and healthcare providers

Transportation is a important part in Pharma supply chain as it involve end-to-end product movement
2 from manufacturing facilities to patients to ensure the specified temperature conditions are consistently
maintained

Transportation qualification and validation are critical components for mitigating risk and ensuring
3
pharmaceutical product safety, integrity and quality to protect patient health

4 Need competency, risk management & assessment, technology for monitoring, strong collaboration
within end-to-end supply chain and continuous improvement to provide a qualified transportation
process
Thank you
APPLICABLE REGULATION FOR PHARMA TRANSPORTATION MANAGEMENT

• Transportation processes are subject to regulatory requirements and guidelines to ensure that pharmaceutical products
maintain their quality and efficacy throughout the entire supply chain process
• Failure to comply with these regulations can lead to product recalls, fines, and reputational damage

➢ CDOB 2020 – Petunjuk Teknis CDOB

➢ BAB XI Ketentuan Khusus Produk Rantai Dingin ( Cold Chain Product CCP)

➢ Pedoman Pendistribusian Vaksin Covid-19 - BPOM

Additional Technical Regulation

WHO Technical Report Series, No.961, 2011
➢ Annex 9, 2014: Model guidance for the storage and transport of time- and temperature–sensitive pharmaceutical
products
➢ Technical supplement to WHO Technical Report Series, No. 961, 2011 Qualification of Temperature Controlled storage
areas, Temperature Profiling, Temperature Mapping for storage Areas

ISPE Good Practice Guide: Cold Chain Management