PharmaceuticalOutsourcingQ42020 - 24

SUPPLY CHAIN

Mapping the Secure
Temperature-Controlled
Supply Chain Requirements
Rafik H. Bishara, PhD,1 Chuck Forsaith,2 and
Henry Moran3
Rafik H. Bishara, Ph.D., Technical Advisor, and (retired)
Director of Quality Knowledge Management,
Eli Lilly and Company.
2
Chuck Forsaith, Vice President - Healthcare Distribution
Alliance, and Pharmaceutical Cargo Security Coalition.
3
Henry Moran, COO, ASC Associates Limited.
1

Introduction
In recent years, global pharmaceutical supply chains have increased in
complexity and scrutinization, due to the involvement of many players with new guidance, regulation and compendial requirements.1-4
For example, compliance with the European Good Distribution
Practice (GDP) of Medicinal Products for Human Use guidelines will
ensure control of the distribution chain and consequently maintain the quality and integrity of the medicinal product as it is being
handled by many different players.1 In addition, the newly published
United States Pharmacopeia <1079>, Risks and Mitigation for the
Storage and Transportation of Finished Drug Products presents a
risk-based approach for the development of Quality Management
Systems (QMS) that includes product and process knowledge, risk
identification, and mitigation strategies with focus on documentation, training, resources, and qualification/validation.2 Furthermore,
pharma serialization has been developed by governments to combat drug counterfeiting that may directly affect the public health.
The main goal of this requirement is to be able to track and trace the
medicines during the supply chain process.3-5
In the current, very unique, time of the COVID-19 pandemic, temperature control of transporting vaccines and medications is becoming even more important and may be unusually challenging, as
some shipment sequences would require cryogenic shipment protocols at -80°C, in addition to the refrigeration 2 - 8°C, and/or freezer
between -25 and -10°C, conditions. Cell and Gene Therapies may require the cryogenic temperatures at -196°C and -80°C, respectively.

Shipment Mapping
With regards to the complexity of these global, temperature sensitive,
supply chains, the " mapping " of the various tasks in the handling,
Pharmaceutical Outsourcing |

24

storage, and transportation of the shipped medicinal products is an
activity, that in many instances, is not documented in enough detail.
A complete and accurate mapping process should help to identify all
entities that would ultimately " touch " the shipped product, in both
storage and transit, as well as the lanes the product will travel through
(from origin to destination), where and for how long the product
might come to rest - recognizing that " cargo at rest is cargo at risk " ,
as well as all of the flow of information surrounding the shipment.
In regard to this process, attention should be paid to the details of
the distribution practices, required environmental conditions, the
benefit technology might provide, and the overall risk evaluation of
the entire process.6
In this paper we will present a model for mapping secure, temperature
controlled, supply chain lanes - as well as comment on secure
shipment practices.

The Mapping Process
In this model we are assuming that the product could be shipped
virtually anywhere around the globe, from the site of origin
(manufacturer, packager, distribution center, etc.) to its ultimate
destination.

Security Check Assessment
Once the shipping origin and destination have been identified,
investigative inquiries should be made of industry associations who
monitor global counterfeiting and product diversion - for any threats
relative to manufacturing, clinical trial processes and ultimate product
distribution. One such organization is the Pharmaceutical Security
Institute.5 It is widely known that counterfeiting groups thrive in
| October/November/December 2020



PharmaceuticalOutsourcingQ42020

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
Roundtable
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
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