PharmaceuticalOutsourcingQ42020 - 27

SUPPLY CHAIN

becomes a " known consigner " , within EU transportation protocols,
or a participant in the United States TSA " Certified Cargo Screening
Program " which would allow for screen-free handling at any airport.
If airport screening is required, that screening should be taking place
in temperature-controlled environments and, where available, be
under full Closed Circuit Television (CCTV) surveillance coverage with a designated witness. Similarly, any areas within an airport cargo
handling area where shipments might be staged, pre-flight, should
be access controlled and also under CCTV surveillance.
If airport screening is required, once the screening activity is
concluded the shipping conveyance should be closed and re-sealed,
with a new sealing device. The entity who performs that re-sealing
procedure should, whenever reasonably possible, be agreed upon in
advance, as well as documented. Any re-sealing device(s) needs to be
recorded on the shipping airway bill.
It is recommended that any airline choice be an entity which is
certified by the International Air Transport Association (IATA) " Centre of Excellence for Independent Validators " (CEIV) program.
This certification was developed for pharmaceutical logistics to
help organizations, and the entire air cargo supply chain, achieve
pharmaceutical handling excellence. The certification recognizes
the carrier's capabilities in handling high-value, time-sensitive,
pharmaceutical products. It also addresses the industry's needs for
safety, security, compliance, and efficiency in the transportation of
pharmaceutical products.7
All times for transportation, staging, screening, customs clearance
and storage, should be documented, similar to what is required of
the qualification process. In line with the principles of GDP these key
processes should be risk assessed.

Items to Consider for a " Mapping Form "
The following is a non-inclusive list of items to be included in any
shipment visibility platform:

*	 Account number
*	 Origin

*	 Air shipment cut off and/or cancellation protocols
*	 Specific ground transportation information, to include
transportation firms, types of vehicles to be used, and service
definitions

*	 Details for pick up times from airline, collection/delivery notes
*	 Any locations where shipment might be temporarily " stored "
enroute to ultimate destination

*	 Identifying information on entities providing storage services:
company name, person of contact, storage attributes -
environmental controls, security

*	 Total planned transit/storage times between origin and
destination

*	 Standard and emergency contact lists for all parties involved
(shipper, receiver, freight brokerage, Customs offices, cargo
insurer, and all transportation/storage entities, to include:
contact name, company, position, office phone number, mobile
phone number, email address

*	 Route design approval: name, company, signature, date
*	 Comments on route risk level

Recommendation for Mapping the Risk
Mitigation of the Secure TemperatureControlled Supply Chain
*	 The entire shipment process should be closely examined, with
an emphasis on reducing (whenever possible) the number
of handling and manipulation points, as well as " rest points " ,
a shipment is being subjected to. From a risk perspective, it
is known that every " handling and manipulation point " (no
matter how familiar, experienced, or " certified " the entity that
is conducting it) subjects the cargo to potential mishandling.
Ground transportation, as opposed to that in the air, also
exposes an increased potential of the product being subjected
to unnecessary/unwanted physical contact.

*	 Investigative inquiries should be made of industry associations

*	 Destination

who monitor global counterfeiting and product diversion - for
any threats relative to manufacturing, clinical trial processes
and ultimate product distribution.

*	 Freight brokerage information: availability at destination,
office/agent, estimated customs clearance time, customs
operating hours.

*	 Contingency plans for issues such as areas of high cargo theft

*	 Airport at origin, any connecting airport, and airport at

risk, political unrest, unusual weather, etc. should be developed
prior to moving any pharmaceutical shipment.

destination

*	 Availability of temperature control facilities at all airports

*	 Whenever reasonably possible, shipments should be

during transit

*	 For each flight segment specific flight information, to include
airline, aircraft type, routing, and service/handling definition

*	 Direct ground transportation routes, as well as nonstop

*	 Estimated time of departure (ETD), estimated time of arrival

flights, should be the preferred mode of moving any shipment
as they reduce the number of handling and manipulation
points and " rests " .

(ETA)

*	 Estimated aircraft loading/unloading times
pharmoutsourcing.com |

" dedicated " , and be the only goods being transported within
the shipping conveyance.

27

| October/November/December 2020
http://www.pharmoutsourcing.com
PharmaceuticalOutsourcingQ42020

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