INSIDER INSIGHT


Current Trends in Global Distribution and Supply Chain


Dave Dreifke


Manager, Clinical Supply Chain & Logistics Xcelience, a division of Capsugel Dosage Form Solutions


When working through the nuances of moving clinical supplies globally, my mind often wanders back to a scenario that occurred several years ago. During a meeting to determine a course of action to facilitate the customs release of clinical supplies in a South American country, a member of senior management entered the conference room to express disbelief in the possibility of supplies being held by customs authorities. “How can this occur? It’s simple, you grab the supplies, put them in a box, label it, put together a packing slip and you’re done.” Wow, don’t we wish it were that easy!


Some of you may have been in a situation, having survived a painful experience that left both yourself and your Study Team wondering if conducting a clinical trial in certain countries was actually worth it.


As an industry we have come a long way from the days of shipping supplies without much understanding of global governmental regulations and the assumed risk of sending supplies into international commerce.


At the same time, governmental agencies have become increasingly aware of industry needs and have implemented reliable guidance, regulation and process change which have contributed to import/export procedures and the movement of commerce and clinical supplies.


In this piece, I’ll cover three new regulations related to clinical supply in the European Union and provide topline recommendations on managing their impact on your business. I’ll also provide thoughts on serialization, one of the hottest global topics to emerge since RFID was bantered around a decade ago.


Electronic Customs


An electronic custom system is being phased in the EU over the next few years. It replaces the Community Customs Code that had legal effect since 1994 and was written at a time when procedures were largely paper based. The volume and speed of trade, as well as the need for proper safety and security risk assessment have increased significantly over the past decades.


As part of the modernization of the EU regulatory framework, the Union Customs Code (UCC) and its Implementing Regulations became effective May 1, 2016. Note that certain provisions of the UCC will only be implemented when the required IT system is either deployed or upgraded. Essentially, once the European Commission has fully de- ployed a portion of the electronic framework necessary to support UCC,


it will then become a portion of the electronic framework that will be viable, usable and enforceable.


Due to infrastructure implementation, the European Commission created an additional regulation that provides provision of a transitional period between May 1, 2016 and December 31, 2020 for electronic customs enhancements to be implemented.


What we should expect:


• Streamline customs legislation and procedures throughout the EU Member States.


• Increase clarity for customs officials.


• Simplified customs rules and procedures that facilitate more efficient customs transactions.


• Greater legal certainty and uniformity to businesses.


• Complete shift by Customs to a paperless, fully electronic environment.


Data Integrity


Data integrity is fundamental in pharmaceutical quality systems. The EU Medicines and Healthcare products Regulatory Agency (MHRA) provides guidance on Good Manufacturing Practice (GMP) data integrity expectations for the pharmaceutical industry. The guidance is intended to complement existing EU GMP related to active substances and dosage forms, recommended to read in conjunction with national medicines legislation and the GMP standards published in Eudralex Volume 4.


The effort and resource assigned to data governance should be commensurate with the risk to product quality, and should also be balanced with other quality assurance resource demands.


Manufacturers and analytical laboratories are not expected to implement a forensic or discovery approach to data checking on a routine basis, but rather design and operate a system that provides an acceptable state of control based on the data integrity risk, and which is fully documented with supporting rationale.


Data integrity requirements apply equally to manual (paper) and electronic data. Manufacturers and analytical laboratories should be aware that reverting from automated computerized to manual/paper- based systems will not in itself remove the need for data integrity controls.


Pharmaceutical Outsourcing | 32 | July/August 2016


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