PharmaceuticalOutsourcingQ42020 - 26

SUPPLY CHAIN

It is important to note that irrespective of the mode of transport a
risk-based approach should be taken when planning transportation
and transportation routes.

The Packaging for Transportation
The proper primary and secondary containers should be determined
by the shipper of origin. In addition, the tertiary and/or the
shipping packaging for transportation, as well as the labeling, must
comply with the good manufacturing practice procedures (GMP).
It is recommended that the shipments be placed in cardboard
master cartons which would have an identification label, as per the
manufacturer GMP procedures, on its outside. It is recommended not
to place specific branding on the master cartons. The carton labels
would have the manufacturer name of the product, a unique identifier
as a part number by the manufacturer, a lot number, an expiration
date; as well as any other information included in the manufacturer's
procedure. For air freight shipments, the IATA Time and Temperature
Sensitive label is required to be used.
Environmental conditions of the shipped product needs to be
managed to prevent any excursion during the transportation. This is
accomplished using active or passive thermal packaging, which has
been qualified from origin to destination - for the time and temperature
of the specific shipping lane. Details of the temperature monitoring
should be justified using the proper loggers and/or qualification data.
Realtime data loggers should be considered - which could allow for
real time corrections over the entire shipment process.
The number of cartons per pallet and the number of pallets per
container should be determined in either a technical or service
agreement between parties. Carrier dedicated containers are
preferred to enhance the opportunities for the shipper's cargo to be
exclusive, within the container itself. Carrier containers need to be
sealed and all sealing devices, and their associated serial numbers,
documented on all shipment paperwork.

Shipping Logistics Coordination
Mapping of the logistics details should be documented. This would
include the ground and air movement of the product by each
carrying entity, each storage entity, any subcontractors, to include
the details of all shipment " hand offs " .
The freight forwarder, for the shipments leaving origin, should be a
recognized (either national and/or international) entity with verifiable
protocols for coordinating the handling of urgent and dedicated,
secure, temperature-controlled pharmaceutical products. Hence,
freight-forwarding entities that have acquired a Good Distribution
Practice (GDP) certification, are in possession of a WDA (Wholesale
Dealers Authorization), are working to GDP compliant standards, and
participate in IATA's CEIV Pharma Program, should be preferred.7
It is advantageous that all delivery conveyances, themselves, be
temperature-controlled and that those entrusted with transporting
the shipments be well versed/trained on Good Distribution Practices.
Pharmaceutical Outsourcing |

As many of the transporting entities as possible, involved in the
movement of these temperature sensitive shipments, should be
able to be " tracked " by both the shipping and the receiving entities.
In certain cases that may involve the use of GPS technology.
As an example, all " ground " transportation vehicles, whenever
reasonably possible, should be equipped with GPS tracking devices.
It is recommended that the shipper, itself, imbed a GPS tracking
device(s) into the cargo whenever possible. The use of real-time GPS,
combined with an environmental (temperature) monitoring device,
is encouraged.
Whenever possible, dedicated shipment trips, with only the specific
product to be shipped on board the ground transporting conveyance,
is preferred.
It is recommended that the freight forwarder, as well as any ground
transport entity, be Transported Asset Protection Association (TAPA)
and/or Authorized Economic Operator (AEO) certified.8 To have
attained those certifications it would be reasonable to believe that
the transport company's vehicles and trailers would be " hard sided " ,
appropriately sealed, tracked by GPS technology, and their drivers
fully versed in supply chain security and GDP protocols.
Finally, ground transportation between two destinations, whenever
possible, should be in a direct non-stop mode. If the distance is
long and would require some rest for the driver, proper parking
precautions, such as those recommended by TAPA, should followed.
Quality, as well as Technical, Agreements should exist between
all stakeholders handling the product from origin to the ultimate
destination. These agreements document the what, who and how the
handling, storage and transportation will be performed - and should
also identify important contacts in the case of emergency, deviation,
temperature excursion or a security breach. The agreements should
clearly delineate roles, responsibilities and duties of each party.

Example of A Shipment Trip
Time of pickup from the origin should be established and the
shipment be readily prepared and sealed with an integrity seal
by a proprietary employee of the shipper of origin. Experience has
shown that it is helpful if the selected freight forwarder coordinates
the acquisition of any shipping conveyances/containers deemed
necessary, for what will be the air carrier of record.
The shipment itself is ultimately loaded into a delivery truck. It is
preferred that the transportation entity selected utilize proprietary
vehicles, as well as proprietary employees (drivers). No subcontractors
should be used without the shipper's knowledge and permission.
Whenever reasonably possible, ground shipments should be " dedicated " , meaning that the products being shipped would be the sole
products within the conveying entity.
It is preferred that the freight forwarder have finalized all of the
necessary documentation before the goods are delivered to the
airline for screening and accepted for the flight. With regards to
any potential screening prior to flight, it is helpful if the shipper
| October/November/December 2020

PharmaceuticalOutsourcingQ42020

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