Pharmaceutical Commerce - May/June 2013 - (Page 20)

Supply Chain/ Logistics The convergence of environmental condition monitoring and supply chain visibility By Henry Ames, Sensitech Inc. 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. [1] Key industry issues include: • 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 Regulatory drivers 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, Fig. 1. USP’s plan for integrating complementary guidances into one and to ensure that temperature conditions Good Distribution Practice document. [5] are maintained within acceptable limits during transport.” To further illustrate this point, PDA’s Technical Report 52 Section 3.2 outlines the scope initiative to expand their own supply chain security programs of Distribution Control Management, stating that it by documenting industry best practices and developing “encompasses the process and controls necessary to ensure standards that are being applied across industry verticals. product integrity and traceability are maintained from the Two examples are the Transported Asset Protection Assn. point of receipt through product distribution.” (TAPA) and Rx360, both of which have published a number Section 3.2.4 Storage and Inventory Control states: “All of important and influential industry documents, including: in-transit storage facilities should have adequate security and environmental control...” Rx 360 Supply Chain Security White Papers Section 3.2.5 Transportation states: “Products should • Threats and Monitoring Processes be transported in such a way that product – is secure (i.e. • Audits and Assessments of Third Party Warehousing and protected against spillage, breakage, or theft)” and “is not Distribution Facilities subjected to unacceptable changes in heat, cold, light, moisture • A Comprehensive Supply Chain Security Management or other adverse influences.” This message is consistent System and supports the confluence of supply chain security and • Cargo Risk Assessment [2] environmental control for both storage and transportation segments of the pharmaceutical supply chain. TAPA Perhaps most importantly, FDA’s “Response to Cargo • Freight Security Requirements (FSR) Thefts,” published in March 2012, states: “The FDA is very • Trucking Security Requirements (TSR) concerned about the increase in cargo and warehouse thefts • TAPA Air Cargo Security Standards (TACSS) [3] of FDA regulated products, including prescription and overthe-counter medicines, vaccines, medical devices, and infant A unified direction for USP formula.” The key issue is an overall concern of threats to As recently presented at several industry conferences, USP public health and potential “adverse reactions, most likely due has outlined its goal to integrate individual components of to improper storage and handling.” general guidance under a single GDP chapter, while extending Along the same lines, governments around the world both the coverage of the products included and the stages have been addressing supply chain security by encouraging of drug development. “The motivation for one chapter in compliance with security standards, including the US the USP is to reduce redundancy and potential conflict and Customs-Trade Partnership Against Terrorism (C-TPAT) and provide a holistic approach to GDPs—one chapter that could the EU’s Authorized Economic Operator (AEO) programs. be used internationally as a standard for importation into Both programs focus on upgrading supply chain security the US and exportation out of the US for pharmaceutical while facilitating trade. By extending the partnership of anti- products,” stated Dr. Mary Foster, chair of USP’s Packaging terrorism principles globally, the international community and Storage Expert Committee. benefits from safer, more streamlined supply chains. The basis for this USP work follows the USP strategic plan Industry leaders from key corporations have taken the to develop standards in the international arena for ensuring DP – Drug Product | EXCP – Excipient | API – Active Pharmaceutical Ingredient | MD – Medical Device 20 Visit our website at May | June 2013 Fig. 2. Scope of various USP guidances and their coverage overlaps. [6]

Table of Contents for the Digital Edition of Pharmaceutical Commerce - May/June 2013

Pharmaceutical Commerce - May/June 2013
Table of Contents
Top News
Brand Marketing & Communications
Supply Chain/ Logistics
Information Technology
Manufacturing & Packaging
Legal & Regulatory
Meetings and Editorial Index

Pharmaceutical Commerce - May/June 2013