PharmaceuticalOutsourcingQ42020 - 27


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

*	 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

*	 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.


*	 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 " .


*	 Estimated aircraft loading/unloading times |

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


| October/November/December 2020


Table of Contents for the Digital Edition of PharmaceuticalOutsourcingQ42020

Editor's Message
Editorial Advisory Board
CN Perspectives
Social Media Connections
Insider Insight - Price
Insider Insight - Ventura
Contract Manufacturing
Supply Chain
Contract Manufacturing
Interview with Yourway
Supply Chain
Clinical Trials
Supply Chain
Analytical Testing
Supply Chain
Clinical Trials
Analytical Testing
Horizon Lines
Industry News
Advertiser's Index
PharmaceuticalOutsourcingQ42020 - Cover1
PharmaceuticalOutsourcingQ42020 - Cover2
PharmaceuticalOutsourcingQ42020 - 1
PharmaceuticalOutsourcingQ42020 - Editor's Message
PharmaceuticalOutsourcingQ42020 - 3
PharmaceuticalOutsourcingQ42020 - 4
PharmaceuticalOutsourcingQ42020 - 5
PharmaceuticalOutsourcingQ42020 - Editorial Advisory Board
PharmaceuticalOutsourcingQ42020 - 7
PharmaceuticalOutsourcingQ42020 - CN Perspectives
PharmaceuticalOutsourcingQ42020 - Social Media Connections
PharmaceuticalOutsourcingQ42020 - Insider Insight - Price
PharmaceuticalOutsourcingQ42020 - 11
PharmaceuticalOutsourcingQ42020 - Insider Insight - Ventura
PharmaceuticalOutsourcingQ42020 - 13
PharmaceuticalOutsourcingQ42020 - Contract Manufacturing
PharmaceuticalOutsourcingQ42020 - 15
PharmaceuticalOutsourcingQ42020 - 16
PharmaceuticalOutsourcingQ42020 - 17
PharmaceuticalOutsourcingQ42020 - Supply Chain
PharmaceuticalOutsourcingQ42020 - 19
PharmaceuticalOutsourcingQ42020 - Contract Manufacturing
PharmaceuticalOutsourcingQ42020 - 21
PharmaceuticalOutsourcingQ42020 - Interview with Yourway
PharmaceuticalOutsourcingQ42020 - 23
PharmaceuticalOutsourcingQ42020 - Supply Chain
PharmaceuticalOutsourcingQ42020 - 25
PharmaceuticalOutsourcingQ42020 - 26
PharmaceuticalOutsourcingQ42020 - 27
PharmaceuticalOutsourcingQ42020 - 28
PharmaceuticalOutsourcingQ42020 - 29
PharmaceuticalOutsourcingQ42020 - Clinical Trials
PharmaceuticalOutsourcingQ42020 - 31
PharmaceuticalOutsourcingQ42020 - 32
PharmaceuticalOutsourcingQ42020 - Roundtable
PharmaceuticalOutsourcingQ42020 - 34
PharmaceuticalOutsourcingQ42020 - 35
PharmaceuticalOutsourcingQ42020 - Supply Chain
PharmaceuticalOutsourcingQ42020 - 37
PharmaceuticalOutsourcingQ42020 - 38
PharmaceuticalOutsourcingQ42020 - 39
PharmaceuticalOutsourcingQ42020 - Analytical Testing
PharmaceuticalOutsourcingQ42020 - 41
PharmaceuticalOutsourcingQ42020 - 42
PharmaceuticalOutsourcingQ42020 - 43
PharmaceuticalOutsourcingQ42020 - Supply Chain
PharmaceuticalOutsourcingQ42020 - 45
PharmaceuticalOutsourcingQ42020 - 46
PharmaceuticalOutsourcingQ42020 - 47
PharmaceuticalOutsourcingQ42020 - Clinical Trials
PharmaceuticalOutsourcingQ42020 - 49
PharmaceuticalOutsourcingQ42020 - 50
PharmaceuticalOutsourcingQ42020 - Analytical Testing
PharmaceuticalOutsourcingQ42020 - 52
PharmaceuticalOutsourcingQ42020 - 53
PharmaceuticalOutsourcingQ42020 - Horizon Lines
PharmaceuticalOutsourcingQ42020 - 55
PharmaceuticalOutsourcingQ42020 - 56
PharmaceuticalOutsourcingQ42020 - 57
PharmaceuticalOutsourcingQ42020 - Industry News
PharmaceuticalOutsourcingQ42020 - 59
PharmaceuticalOutsourcingQ42020 - 60
PharmaceuticalOutsourcingQ42020 - 61
PharmaceuticalOutsourcingQ42020 - 62
PharmaceuticalOutsourcingQ42020 - 63
PharmaceuticalOutsourcingQ42020 - Advertiser's Index
PharmaceuticalOutsourcingQ42020 - Cover3
PharmaceuticalOutsourcingQ42020 - Cover4