By David A. Loy, Senior Director of Quality and Regulatory Affairs, Aphena Pharma Solutions
A step-by-step guide to implement track and trace.
With every recurrence of confirmed counterfeit drug product in the pharmaceutical supply chain, the pressure increases to establish a national standard for pharmaceutical track-and-trace solutions. Although a universal standard has yet to emerge, there is one set of requirements that is currently driving action: the California Board of Pharmacy’s ePedigree.
Moreover, with considerable attention from legislators, regulators, and standards organizations to track and trace a pharmaceutical product throughout its lifecycle, drug manufacturers and packagers are under increased pressure to implement serialization to provide supply-chain integrity to the public.
However, with the deadlines for the California Board of Pharmacy’s ePedigree law quickly approaching, it will be vital for the industry to accelerate its efforts to start putting compliance measures in place in 2013.
With the accelerated pace of regulatory involvement worldwide in serialization and track and trace, a strong working foundation of imminent requirements is necessary.
Several of the U.S. states are in the process of creating legislation for ePedigree; however, California is, by far, drawing the most attention for two reasons:
California’s legislation is written such that it will effectively be usurped by federal legislation, but it is not known when the feds may introduce similar or overriding legislation. The bottom line? The deadline is fast approaching, and action needs to be taken now in order to comply with the impending law. As you contemplate your track-and-trace efforts or are putting systems in place, you should first keep the following considerations in mind.
Any and all systems added or maintained to resolve the ePedigree initiative must be compliant with the regulations. Although the need to attack the problem of counterfeit medicines in the supply chain is obvious, many of the system design considerations may be derived from an analysis of the regulations the system(s) will address. The following are regulations to keep in mind to help guide your process:
Within GAMP 5, topics include how:
Ask The Right Questions To Form Your Strategy
Apply a structured analysis of the integrated automation system to assure adequate understanding of the processes and scope of the effort (i.e. determine what business processes, system interfaces, and human control activities need to be assessed) prior to formal project Scope Statement.
Questions to be addressed for this phase should include the following:
The project plan should consider task ownership so that there are clear expectations of who will deliver what and when. Although this consideration is universally applicable to all elements of the project, the bottom line is that the delivery of the system, including all software, hardware, documentation, and on-going support and maintenance, must be well understood and agreed upon in writing.
Test, And Test Again
As with any complex project, there will be a lot of trial and error, potentially resulting in rejects and rework. This is primarily because now we are aggregating serial numbers into containers holding smaller serialized units. When the serial-number “chain” is disrupted for whatever reason, the human business processes’ and automated systems’ capabilities to cope with the management of such an issue is key.
Although there are a number of potential scenarios that will inevitably occur, the following is an example based on a standard high-speed packaging operation of between 100 to 200 bottles per minute:
It is evident that any fault in the data linkage will result in significant lost production time. Moreover, considering throughput on today’s high-speed packaging lines, a failure scenario such as the one described above could have significant cost and/or compliance impact.
Internal Corporate Requirements
Of course, not all of the system requirements will be gleaned from a review of the regulations. So, in addition to the user requirements focused specifically on meeting the regulations, additional requirements will need to be gathered and documented clearly describing our internal users’ expectations for the delivered system. Examples of requirements for this group may read similar to these:
Although the expectations from legislators, regulators, and standards regarding track and trace of pharmaceutical product are being communicated to the industry, it is quickly becoming evident that there are resource limitations throughout the industry to address these new expectations. Attention must now be focused on the extended project piloting and implementation time requirements to get these systems up and running in an accelerated fashion.
At this point, you must implement an aggressive time line to meet the minimum compliance requirements of the California ePedigree Law. I have included one project plan approach, focused on fulfilling the basic requirements. Adherence to the plan does not guarantee a successful implementation, as there are a myriad of variables; however, failure to establish a plan at this late stage certainly guarantees the inability to effectively comply.
David A. Loy currently serves as Senior Director of Quality and Regulatory Affairs for Aphena Pharma Solutions in Cookeville, TN. Loy has been involved in track-and-trace, pedigree, and unit-level serialization since 2006. Loy developed, approved, and implemented a fully traceable, unit-level serialization program that has produced over 25 million uniquely identified units. Loy maintains current Designated Representative status in both California and Florida and is well versed in the regulatory requirements and implications of existing and pending state and national legislation associated with track and trace, including serialization. Loy holds a MA and BA in English from Tennessee Technological University located in Cookeville, TN.