Susan Griggs, Eli Lilly

		The Transported Asset Protection Assn. (TAPA) is a voluntary trade association composed of members from industry (shippers), logistics services providers (LSPs), law enforcement agencies, standards auditors and others. It was formed in 1997, and now has regional groupings: TAPA Americas (

). TAPA Americas already has nearly 20 major pharma companies as members.

		TAPA’s mission is to minimize cargo losses from the supply chain. TAPA achieves this through the development and application of global security standards, recognized industry practices, technology, education, benchmarking, regulatory collaboration, and the proactive identification of crime trends and supply chain security threats. TAPA’s vision is an international supply chain where controlled and traceable product can be transported in a cost-efficient and secure environment.

		The TAPA standards provide a set of security requirements that are specific enough to be effective, yet appropriate for global use in a variety of risk environments. Having a common set of requirements allows Logistics Security Providers (LSPs) to focus on good security measures that protect a wide variety of high value cargo. A certifiable global standard increases efficiency, transparency, and provides a recognized level of security, both for the LSP and for the customers they serve. The key standards are:

			Warehousing/Distribution Centers: Facility Security Requirements (FSR)

			Trucking Fleets: Trucking Security Requirements (TSR)

			Airport Facilities: Transportation Air Cargo Security Standards (TACSS) (not certifiable at this time)

		LSPs achieving TAPA certification have demonstrated their commitment to security by complying with the TAPA standards, participating in independent certification audits, and conducting periodic self-audits. Certifications are granted for each individual warehouse or trucking fleet. In the future, TAPA expects additional focus on truck fleet certifications as cargo theft frequently involves theft of, or theft from a trailer.

		Before launching an initiative to implement TAPA standards, there are three key areas for decisionmaking and research:

			Scope — Will the TAPA standard be applied to all pharmaceutical products, such as active pharmaceutical ingredients (API), physician samples, clinical trial material, animal health products, and return goods, or will it only apply to commercial human finished products? Will it apply to bulk product or only product in final packaging? Will it apply to company owned facilities or only to third party sites or transporters?

			Relative Risk — Will every country or facility be required to perform at TAPA Level 1/Level A or is it acceptable for some lower risk areas to adopt TAPA Level B or C?

			Cost/Benefit/Return on Investment (ROI) — The most important reason for securing pharmaceutical products is to protect patients. However, it is very difficult to estimate the cost impact of an unfortunate event such as theft, tampering or diversion. Fortunately, in most cases, TAPA standards produce an attractive ROI, even without including the cost of patient impact.

		When determining ownership of implementing TAPA standards, pharma managers should determine which functions are most invested in cargo security. It could be logistics, security, quality, or procurement. In the most successful models, security partners with another key function (ex: logistics). Cross-functional ownership supports a balanced approach and can provide a broader range of skill sets over a single function trying to manage it alone. When identifying key stakeholders, consider which ones are active participants and which are passive supporters (i.e. need to be informed but not active participants). The core group should include at a minimum representatives from security, logistics, warehousing, and quality.

		Recently, the governing body of all TAPA regional associations has decided to develop a sub-group dedicated to the specific needs of the pharma industry. A particular concern will be integrating the methods and technologies associated with protecting temperature-controlled pharmaceuticals during storage and transit. This effort should enable pharma manufacturers and their LSPs to better coordinate industry best practices for both security and temperature control.

		Susan Griggs is advisor, global security, at Eli Lilly and Company, Inc. Rafik H. Bishara, retired, Director, Quality Knowledge Management and Technical Support, Eli Lilly.

Articles

Ultimately, supply chain integrity should include both temperature control and security against theft or diversion