PharmaceuticalOutsourcingQ42020 - 28

SUPPLY CHAIN

*	 All entities that are involved in the handling of pharmaceutical
products in that delicate supply chain should be trained/
certified in GDP programs and procedures

*	 Quality/Technical Agreements, between all stakeholders of the
shipping supply chain, should outline the desired quality and
security requirements.

Acknowledgement
The authors would like to thank the following colleagues for their
review and comments while preparing this article Zvonimir Majic,
Ph.D., TEVA Pharmaceutical Industries Ltd., Erik J. van Asselt, Ph. D.,
Merck, Robert H. Seevers, Ph.D., Pearl Pathways, and Nina Heinz, DHL.

*	 Each individual shipment should be accompanied by
an independent temperature logger and temperature
management should be incorporated in all parts of the
handling, storage, and transportation of the cargo.

References

*	 The shipper should include at least one, proprietary, GPS
tracking device in each of these shipments. The shipper should
also require tracking technology be provided, through the
freight-forwarder, by all transportation vendors. These devices,
collectively, would not only monitor the shipment while in
transit, but also whenever it was staged or resting in storage
between movements.

*	 The privileges of being designated a " known cosigner " ,
particularly in Europe, should be investigated to eliminate the
need for airport cargo security screening - before a shipment
is placed into a transporting aircraft. Similarly, membership in
the US TSA's Certified Cargo Screening Program would be just as
beneficial. What you want to avoid, in case of the cosigner, is the
opening of any conveyance/container by airport security entities
to comply with government security screening requirements.

*	 Ground delivery vehicles should be as nondescript as possible.
Hence expressive " vendor brand " or " pharma " markings should
be avoided. Research has shown that a delivery vehicle that is
free of such markings draws far less illicit attention than one
that has them.

*	 The cargo compartment of the vehicles, making a pickup at
facilities or directly to/from airports should be sealed with a
security seal and the truck be alarmed in the event someone
tries to illicitly enter the cargo compartment.

*	 Partners in the secure temperature-controlled supply chain should
be certified by TAPA under the Association's Transported Security
Requirements [TSR] and Facility Security Requirements [FSR].8

*	 The mapping process should be verified on a regular basis and
should be updated as experience is gained, the regulations
have changed, as well as if any specific contacts have changed.

*	 Best practice involves a physical audit of the secure
temperature-controlled supply chain. The use of experienced
Supply Chain Security and GDP auditors should be considered.

*	 Only qualified and approved subcontractors should be used to
ensure GDP compliance at all levels of the supply chain.

Disclaimer
The content and the views expressed in this document are the result
of a consensus achieved by the authors and are not necessarily views
of the organizations they present or represented.
Pharmaceutical Outsourcing |

The mention of a product or service provider does not mean it is the
sole product or service that is available for use.

28

1.	 European Commission: Guidelines on Good Distribution Practice of medicinal products for
human use, 2013/C 343/01, November 2013.
2.	 United States Pharmacopeia, USP, <1079> Risks and mitigating strategies for the storage
and transportation of finished drug products.
3.	 The European Falsified Medicines Directive.
4.	 ITS (Turkey), website (in English): https://www.its.gov.tr/index.php?run=home.
5.	 Pharmaceutical Security Institute (PSI), www.psi-inc.org.
6.	 Van Diest, G-J., and Bishara, R. H., et. al.: Pharmaceutical Supply Chain Security Risk
Assessment for Shipping Lanes. Journal of Pharmaceutical Outsourcing, Volume 18, Issue
of September/October 2017, pp. 16-25.
7.	 https://www.iata.org/en/programs/cargo/pharma/ceiv-pharma/ .
8.	 https://www.tapa-global.org/information/latest-news-views/news-detail-view/fsr-and-tsrsecurity-standards-certifications-continue-to-climb-in-emea.html.

Dr Rafik H Bishara has become one of the most respected figures
in the pharmaceutical supply chain distribution sector, following
a distinguished 35-year career with Eli Lilly and Company
as Director, Quality Knowledge Management, and Technical
Support. He is the former (1999-2019) Chair of the Pharmaceutical
Cold Chain Interest Group, US branch, within the PDA. Rafik is currently on the
pharmacy advisory council Utilization Review Accreditation Commission. He
was a temporary advisor to WHO 2007-2018 and acted as mentor and training
advisor to the WHO-PDA Pharmaceutical Cold Chain Management on Wheels.
Chuck Forsaith has been involved in pharmaceutical supply
chain security for more than 20 years, after having served
as both a New Hampshire municipal and State Police officer and formally directing security operations for a United States
military intelligence gathering installation. His responsibilities
with the Healthcare Distribution Alliance's " Pharmaceutical Cargo Security
Coalition " include offering supply chain security intelligence; access to
contacts from industry, government, and vendor trade disciplines; as well as
education. The PCSC, which consists of many individuals from a wide variety
of disciplines, monitors the security of pharmaceutical goods in both transit
and storage - all over the world. Primarily (but not exclusively) focused on the
pharma industry, the PCSC provides useful insights for anyone interested in
supply chain security.
Henry Moran joined ASC Associates in January 2016 as Director.
The role allows him to use his operational and academic
experiences to support clients in obtaining their respective
GDP accreditation, providing GDP compliance and supply
chain security audits, gap analysis on the GDP requirements,
combined with facilitating the ASC GDP and RP for Logistics courses. Prior to
joining ASC Associates, he worked for Mundipharma where he started in 2006
as the International Supplies Manager. In the role he had responsibility for the
global supply and logistics of delivering product to the customer. The role also
included the evaluation and mitigation of risks of pharmaceutical products in
the Global Supply Chain, compliance with regulatory guidelines and Cool Chain
Management. Prior to working at Mundipharma, Henry worked in numerous
logistics roles in Hi-tech Electronics, Global Logistics and Freight Forwarding.
Henry is a Six Sigma Black Belt and studied in the UK at the University of
Plymouth and at University College Dublin and holds a Master's in business
studies specializing in Manufacturing and Logistics.
| October/November/December 2020


https://www.its.gov.tr/index.php?run=home http://www.psi-inc.org https://www.iata.org/en/programs/cargo/pharma/ceiv-pharma/ https://www.tapa-global.org/information/latest-news-views/news-detail-view/fsr-and-tsrsecurity-standards-certifications-continue-to-climb-in-emea.html

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
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PharmaceuticalOutsourcingQ42020 - 5
PharmaceuticalOutsourcingQ42020 - Editorial Advisory Board
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PharmaceuticalOutsourcingQ42020 - CN Perspectives
PharmaceuticalOutsourcingQ42020 - Social Media Connections
PharmaceuticalOutsourcingQ42020 - Insider Insight - Price
PharmaceuticalOutsourcingQ42020 - 11
PharmaceuticalOutsourcingQ42020 - Insider Insight - Ventura
PharmaceuticalOutsourcingQ42020 - 13
PharmaceuticalOutsourcingQ42020 - Contract Manufacturing
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PharmaceuticalOutsourcingQ42020 - Supply Chain
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PharmaceuticalOutsourcingQ42020 - Contract Manufacturing
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PharmaceuticalOutsourcingQ42020 - Interview with Yourway
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PharmaceuticalOutsourcingQ42020 - Supply Chain
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PharmaceuticalOutsourcingQ42020 - Clinical Trials
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PharmaceuticalOutsourcingQ42020 - Roundtable
PharmaceuticalOutsourcingQ42020 - 34
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PharmaceuticalOutsourcingQ42020 - Supply Chain
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PharmaceuticalOutsourcingQ42020 - Analytical Testing
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PharmaceuticalOutsourcingQ42020 - Supply Chain
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PharmaceuticalOutsourcingQ42020 - Clinical Trials
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PharmaceuticalOutsourcingQ42020 - Analytical Testing
PharmaceuticalOutsourcingQ42020 - 52
PharmaceuticalOutsourcingQ42020 - 53
PharmaceuticalOutsourcingQ42020 - Horizon Lines
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PharmaceuticalOutsourcingQ42020 - Industry News
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PharmaceuticalOutsourcingQ42020 - Advertiser's Index
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