Global Implementation of

the Pharma & Healthcare

Asia Shipping

Jackson Campos Fernando Piza

Global Head – Pharma & Healthcare Key Account – Pharma & Healthcare
Summary
• 1. Introduction to the Pharma Product and Global Team
• 2. Pharma Industry
• 3. AS Pharma Global Implementation Program
• 4. Cold Chain
• 5. Manual of Quality and SOPs
• 6. Always let the Pharma Global team be aware of what you’re doing
• 7. Continuous training Program = High Level of Service
• 8. The Vertical
• 9. Conclusion
1. Introduction to the Pharma Product
• 1.1 Global Team
• Jackson Campos – Global Head
• Fernando Piza – Key Account

• 1.2 The Product Pharma & Healthcare is a Global department that works with each
local departments and verticals to:

• Establish the parameters for a Pharma Department / Vertical

• Appoint the assigned staff
• Continuous training program
• Introduce to partners and solutions
• Help creating robust procedures and documentation focusing the Pharmaceutical industries
standards
1. Introduction to the Pharma Product
• 1.1 Global Team
• Jackson Campos – Global Head
• Fernando Piza – Key Account

• 1.3 What are the customers of the Pharma Global Department?

• All customers that have operations with Human Health products, like the Pharma,
Healthcare, Bio and lifescience.
• What doesn’t the Pharma Global Department handle?
• Food and Vet products.
2. Pharma Industry
• 2.1 Numbers of the Pharma Industry Globaly *
2. Pharma Industry
• 2.1 Numbers of the Pharma Industry Globaly
2. Pharma Industry
• 2.1 Numbers of the Pharma Industry Globaly
2. Pharma Industry
• 2.2 Health Bureaus / Regulatory Agencies

• Pharma is one of the most regulated industries worldwide, and that’s

because it carries the responsability for people’s lifes well being
• Regulatory agencies impose extremely strict rules and demand
written proof for EVERY thing
• Regulations differ from country to country, however, tends to be every
year more uniform between countries around the world
2. Pharma Industry
• 2.3 Documented procedures
• It is to be expected that the Pharma Industry will expect the same standard
from its Logistic Providers.
• So in order to be considered a Freight Forwarder expert in Pharma Handlings
we need to follow the same standards. As the logistic provider is and
extension of the industry.

• For starters: Manual of Quality, SOPs for every different operation of every
different customer, assigned staff for this Market in continuous training
programs, follow the GDP guidelines, know and be capable of handling all
sorts of solutions for cold chain shipments.
3. AS Pharma Global Implementation
Program
• 3.1 This program consists in the implementation of the Pharma
Department / Vertical in every AS Office by levels of proficiency.

• Every office starts at level 0 and as the office keeps advancing on the actions
that are needed, it achieves higher levels.
3. AS Pharma Global Implementation
Program
• Level 1: Introductory
• A AS office level 1 in Pharma has already assigned staff in all the key departments;
• This staff went through the introductory trainings in AS E-Learning Platform;
• Duly trained in Active and Passive solutions for cold chain;
• The team is somewhat familiar with the providers of Active and Passive Solutions for
cold chain;
• Envirotainer Academy GDP certification per person;
• Basic understanding on the Ocean Freight Pharma GDP solutions;
• Agreement with Pharma Trucking companies.

• *At this point, every sensitive to temperature cargo handling must involve the global
Pharma department to follow up with the local team. Add pharma@br-asgroup.com
3. AS Pharma Global Implementation
Program
• Level 2: Standard
• Agreement with a specialist customs broker company / training internal staff;
• Agreement with a GDP compliant Warehouse with freezer, refrigerated and cool room (-20 to -10ºC, 2º to
8ºC and 15º to 25ºC). SOPs must be made together;
• Capable of Pricing and operating cold chaing shipments;
• Manual of Quality creation;
• Have at least one Pharmaceutical Technical Responsible in the staff;
• Creation of SOPs for each route and customer;
• Pricing team must be in contact with passive and active solutions providers;
• Always have a contingency plan for the Operations;
• Capable of offering Data loggers; Thermal Blanket and dry-ice replacement;
• CAPA (Corrective Actions, Preventive Actions) Procedure for no conformities, with an analysis of tendencies

• *At this point, every sensitive to temperature cargo handling must involve the global Pharma department
to follow up with the local team. Add pharma@br-asgroup.com
3. AS Pharma Global Implementation
Program
• Level 3: Pharma Specialist
• Establishing a VERTICAL: Every department will count on dedicated staff that will report to
the Pharma Product: (Pricing, Operation and Commercial teams)
• GDP and / or CEIV certified;
• Manual of Quality must be very robust, as well as the SOPs, periodically revised;
• Continuous training program for the vertical;
• Training for more complex Operations, such as (Cryo, High Value inputs, Cell banks, etc);
• Warehouse Staff well be trained for Pharma handlings: Stuffing active and passive
containers, preconditions, prepare cooling material (with SOPs for each operation);
• Have a Pharma Product Manager.

• *At this point, the local team needs to envolve the Pharma product only in complex
handlings and what it considers necessary. Add pharma@br-asgroup.com
3. AS Pharma Global Implementation
Program
• Level 4: Pharma Expert
• Office already proficient in complex Pharma handlings;
• Have a dedicated Pharma commercial team;
• Have a Courier specialist in the Pharma team;
• Pharmaceutical technical responsible plays a key role in every action and
development of SOPs for each temperature sentive cargo handling.
3. AS Pharma Global Implementation
Program
• Level 5: Pharma 4PL
• Own GDP Warehouse * (I can be a third part, as long as the office has the flexibility to
request hiring new employees, Pharmaceuticals, can train constantly the teams, create
SOPs, contengency plans and can do qualifications and physical inspections regularly);
• Own GDP Truck fleet (TCV and Isothermal) * (I can be a third part, as long as the office
has the flexibility to request hiring new employees, Pharmaceuticals, can train
constantly the teams, create SOPs, contengency plans and can do qualifications and
physical inspections regularly);
• Air, ocean and land shipment consolidations, under the ranges of temperature;
• License and trained teams for fragmentation and distribution of temperature sensitive
cargo;
• Have a pharmaceutical technical responsible team supervising the warehouse
operations.
4. Cold Chain
• 4.1 According to the World Health Organization: “The system used for storing any
temperature sensitive good in good condition is called the cold chain. (…) The cold chain consists of a
series of links that are designed to keep temperature sensitive goods within WHO recommended
temperature ranges, from the point of manufacture to the point of administration” – Adapted.

• In other words, a Cold Chain is the supply chain of sensitive to temperature goods. The most common
ranges of temperature used in storing and logistics are:
• 2º to 8ºC;
• 15º to 25ºC;
• -20ºC;
• +35ºC;
• -80ºC;
• -196ºC.
4. Cold Chain
• 4.2 The cold chain is as Strong as its weakest link.
4. Cold Chain
• 4.3 Solutions for transportation in Cold Chain
• Active Solutions are based on electricity to keep the cargo inside the range of
temperature and its main caracteristic is that it is adaptable to external
changes of temperature.
4. Cold Chain
• 4.3 Solutions for transportation in Cold Chain
• Active Solutions
• They need to be plugged into the electric outlet so the battery level keeps the
equipment working.
4. Cold Chain
• 4.3 Solutions for transportation in Cold Chain
• Active Solutions
• There must be SOPs written in order to make sure there won’t be any temperature
excursions;
• The Stuffing must be done by a trained team or the shipper’s team, always folloing the
shipper’s instructions;
• Make sure the equipment is already turned on and in the proper temperature before
stuffing the goods in it.
• Once the cargo is stuffed and the equipment closed, never open them again unless
extremely necessary;
• Always count on the expertise of the Global Department for those Operations:
pharma@br-asgroup.com
4. Cold Chain
• 4.3 Solutions for transportation in Cold Chain
• Active Solutions
• Types of active solutions

• Air active container based purely on electricity

• Air active container based on electricity and Dry Ice
• Ocean reefer container
• GDP Ocean reefer container (Serial numbers of containers dedicated to Pharma
products)
4. Cold Chain
• 4.3 Solutions for transportation in Cold Chain
• Passive Solutions are based on isulated and cooling material solutions
• These solutions are more complex to handle and demand certain expertise to choose the best
solution for each demand and qualify the operation, always consulting and getting approval
from the Quality department of the customer and the spec of the package.
• The qualification of operation works like this:
• It is calculated the amount of hours that will be needed for this transport;
• Adequated insulated and cooling material are chosen that are meant to complete the shipment
without temperature excursions (when the temperature of the cargo goes higher or lower than the
intended range).
• At least 3 trials must be done to see if it works out as planned;
• Data Loggers must be placed to measure the temperature;
• Once all of it is done, the documents of qualification finished and approved by the customer and
Pharmaceutical Technical responsible approved, there’s the Green light to go ahead.
4. Cold Chain
• 4.3 Solutions for transportation in Cold Chain
• Passive Solutions
• Types of passive solutions
• Dry Ice

• It’s a cooling material that while it sublimes, it releases a temperature at -79,6ºC

• So it’s a solution used only for DEEP FREEZE shipments;
• It is also considered dangerous good, as it releases considerable amounts of CO2 while it
sublimes, therefore it’s toxic, according to IATA;
• Always follow the shipper’s instructions about the quantity of dry ice to be used.
4. Cold Chain
• 4.3 Solutions for transportation in Cold Chain
• Passive Solutions
• Types of passive solutions
• Pallet Shippers / Insulated boxes
• Made with materials built to stop the exchange of temperature from outside to inside and cooling
materials, that could be Phase Change Materials, or what based cooling materials.
4. Cold Chain
• 4.3 Solutions for transportation in Cold Chain
• Passive Solutions
• Types of passive solutions
• Phase Change Materials (PCM) are cooling materials chemically designed to have its freezing
and unfreezing point in a certain temperature. For example, for shipments between 2º and
8ºC, most likely the PCM will freeze and unfreeze at the temperature of 5 or 4,5ºC, exchanging
this temperature with the cargo inside the package.
4. Cold Chain
• 4.3 Solutions for transportation in Cold Chain
• Passive Solutions
• Types of passive solutions
• Thermal Blankets blankets designed to cushion the exchange of temperature between the
inside and outside. Some even are designed to keep the external humidity to enter the cargo.
• This solution is an extra-precaution and usually not accepted for qualifying routes.
4. Cold Chain
• 4.3 Solutions for transportation in Cold Chain
• Passive Solutions
• Types of Active solutions
• Cryogenic solutions
• Usually Liquid Nitrogen is put into a sponge and releases the gases that will keep the cargo
in -150ºC or lower. Commonly used for
4. Cold Chain
• 4.3 Solutions for transportation in Cold Chain
• Data Loggers
• Devices used to register the temperature during the shipment and some even
humidity.
• Usually the health bureaus of each country will validate to be used the ones that are
proved to be uncrackable, therefore, there report is trustable.
5. Manual of Quality
• 5.1 Manual of quality is one of the main foundations of the Pharma
Global Department and it will be requirred that every AS office to
create their own.
• It was said early in this presentation that the Pharma industry is extremely
rigid in terms of written documents.
• Each industry has their own Manual of Quality, which bases each and every
SOP they make. As an extension of the Industry, the Freight forwarders
couldn’t be any different.
• It consists basically in one document that will guide the standard operations,
document creations and regular audits, either internally and in every supplier.
6. Always let the Pharma Global team be
aware of what you’re doing
• 6.1 The ultimate goal of the Pharma Global department in Asia Shipping
is being able to attend the global Customers and the most complex
shipments.
• That’s why it’s of primary importance that all strategies and Operations
of every Asia Shipping branch for the Pharma Industry to be aligned with
the Pharma Global team.
• Asia Shipping has been work hard to create its Branding on this Market,
and any mistake made could jeopardize those efforts.
• You can always count on the Pharma Global Teams. Reach out to Jackson
Campos and Fernando Piza (put contacts, linked in and group email
address).
6. Always let the Pharma Global team be
aware of what you’re doing
• 6.2 Never Forget to
Include the
Pharma Customers
in the CW1 in the
Pharma Vertical.
6. Always let the Pharma Global team be
aware of what you’re doing
• 6.2 Never Forget to
Include the
Pharma Customers
in the CW1 in the
Pharma Vertical.
7. Continuous training program
• This is a thing already in Asia Shipping’s DNA. As well as essential for
dealing with the Pharma Industry.
• All the Verticals and Departments of Asia Shipping office will be
required to have constant training for the assigned staff, with
documented proof.
• Constant updates and trainings will be provided by the Pharma Global
Team.
• Continuous training Program = High Level of Service
8. The Verticals / Departments
• 8.1 Departments of Pharma in the local offices are the departments involved with the
Global team and will be the link to the local assigned staff for Operations, Pricing,
development of suppliers.
• As well as developing strategies in accordance to the local management and the
Pharma Global Department aims.

• 8.2 Verticals of Pharma will come in a stage when the local office is already hanlding a
certain amount of Pharma Shipments, has already some know-how in that area.
• A Vertical is a Cell of assigned staff for the Pharma handlings in each of the
departments. In the Pricing, Operation, Quality and Commercial department there will
be the assigned staff Exclusively for handling the Pharma shipments. And this team will
report to their management, as well as to the Pharma Management in the local office,
hence to the Pharma Global Team.
9. Conclusion
• The Pharma Industry is highly regulated and needs to have very strict
rules and document everything.
• In order to be known as one of the main suppliers for them in the
Freight Forwarding Industry, Asia Shipping needs to understand it and
adapt.
• Have a strong team that is eager to learn and put in practice the best
practices to supply to this very demanding industry is our main asset