Henry Ames, Sensitech Inc.

Fig. 1. USP’s plan for integrating complementary guidances into one

						Good Distribution Practice document. [5]

		The complexity of global supply chains has continued to increase as companies leverage regional strengths in human capital, tax benefits, operational excellence, and technological expertise, to name a few. However, as supply chains become increasingly complex, companies need to deploy applications and services that provide greater visibility and, ultimately, help to manage and reduce risk. Given these trends, the melding of environmental (or product condition) tracking with data that supports supply chain integrity has become a necessary tool for supply chain and security risk practitioners worldwide.

		The global regulatory and standards-based guidance covering the storage, handling, and distribution of temperature-sensitive medicinal products has increased dramatically over the past several years. Equally as dramatic has been the attention paid to pharmaceutical supply chain security.

		The pharmaceutical industry has long pushed to unify efforts that secure the supply chain from various risks, including counterfeit, diversion, and theft with efforts to ensure proper environmental controls. It is widely known that a temperature-abused product has the potential to be just as dangerous as a counterfeit product. Therefore, a Quality Management System (QMS) that does not require the monitoring of both security and environmental controls may allow unknown or poorly understood risks to continue. 

			Increased regulatory scrutiny across the supply chain and new product categories

			Expansion of Good Distribution Practices (GDP) and associated regulatory and standards-based guidance

			Holistic approach to supply chain integrity, incorporating both environmental condition monitoring and documentation of a secure supply chain

			Convergence of industry and technological trends driving greater supply chain transparency and added value

		Since 2005, more than 30 documents have been published covering GDPs that all have one recurring and consistent theme—increased scrutiny of the pharmaceutical supply chain and demands for documentation ensuring product quality and patient safety. Recent examples include:

			Parenteral Drug Assn.’s (PDA) Technical Report 52: “Guidance for Good Distribution Practices (GDPs) For the Pharmaceutical Supply Chain,”

			US Pharmacopeia’s (USP) General Chapter <1079> “Good Storage and Distribution Practices for Drug Products”

			Health Canada’s “Guidelines for Temperature Control of Drug Products during Storage and Transportation” (GUI-0069)

			World Health Organization’s (WHO) Annex 9: “Model Guidance for the Storage and Transport of Time and Temperature-Sensitive Pharmaceutical Products,”

			European Union’s “Guidelines on Good Distribution Practices of Medicinal Products for Human Use,” which was published March 7, 2013.

		While the extensive list of aforementioned GDPs outline expectations for appropriate storage conditions during both warehousing and distribution, these newer guidelines call for more broadly defined Supply Chain Integrity—specifically cargo security. For example, the Quality Management Principle outlined in the new EU GDP states: “All distribution activities should be clearly defined and systematically reviewed.”

		Chapter 5 — Operations (5.8 Supply) states: “…a document must be enclosed stating…applicable transport and storage conditions”

		Chapter 9 — Transportation (9.1 Principle) provides clear expectations for wholesaler responsibilities. “It is the responsibility of the supplying wholesale distributor, to protect medicinal products against breakage, adulteration and theft, and to ensure that temperature conditions are maintained within acceptable limits during transport.”

		To further illustrate this point, PDA’s Technical Report 52 Section 3.2 outlines the scope of Distribution Control Management, stating that it “encompasses the process and controls necessary to ensure product integrity and traceability are maintained from the point of receipt through product distribution.”

		Section 3.2.4 Storage and Inventory Control states: “All in-transit storage facilities should have adequate security and environmental control...”

		Section 3.2.5 Transportation states: “Products should be transported in such a way that product — is secure (i.e. protected against spillage, breakage, or theft)” and “is not subjected to unacceptable changes in heat, cold, light, moisture or other adverse influences.” This message is consistent and supports the confluence of supply chain security and environmental control for both storage and transportation segments of the pharmaceutical supply chain.

		Perhaps most importantly, FDA’s “Response to Cargo Thefts,” published in March 2012, states: “The FDA is very concerned about the increase in cargo and warehouse thefts of FDA regulated products, including prescription and over-the-counter medicines, vaccines, medical devices, and infant formula.” The key issue is an overall concern of threats to public health and potential “adverse reactions, most likely due to improper storage and handling.”

		Along the same lines, governments around the world have been addressing supply chain security by encouraging compliance with security standards, including the US Customs-Trade Partnership Against Terrorism (C-TPAT) and the EU’s Authorized Economic Operator (AEO) programs. Both programs focus on upgrading supply chain security while facilitating trade. By extending the partnership of anti-terrorism principles globally, the international community benefits from safer, more streamlined supply chains.

		Industry leaders from key corporations have taken the initiative to expand their own supply chain security programs by documenting industry best practices and developing standards that are being applied across industry verticals. Two examples are the Transported Asset Protection Assn. (TAPA) and Rx360, both of which have published a number of important and influential industry documents, including:

Rx 360 Supply Chain Security White Papers

			Audits and Assessments of Third Party Warehousing and Distribution Facilities

			A Comprehensive Supply Chain Security Management System

			TAPA Air Cargo Security Standards (TACSS) 

Henry Ames, Sensitech Inc.

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