Pharmaceutical Compliance Monitor
2 April 2012
Over time, all industries slide into inefficient habits. Albert Einstein may have captured the root of this reality with the eloquent observation that insanity is “doing the same thing over and over again and expecting different results.”
Pharma is well aware of this, especially when it comes to the way global companies are managing changes to their products.
Traditionally, companies evaluate and implement changes as they arise. For the most part, these changes are initiated, evaluated and driven by manufacturing and supply chain organisations to drive down costs. These evaluations may or may not consider downstream costs of changes to the dossier (submission fees, costs to author and publish submission documents overhead costs to process and approve the changes). Changes are typically implemented by a ‘first in, first out (FIFO)’ prioritisation with some allowance for expediting critical matters.
This approach has always been challenging. In a global arena with distinct regulations for each country, a single change may have different submission paths, content and criteria for any given market. And internally, when it comes to total costs needed to maintain registrations, the lack of visibility can make it difficult to implement intelligent decisions across departmental boundaries.
Trends over the past few years are turning this already harrowing process into one that is almost impossible to manage efficiently. In addition to newly marketed products, the industry has put a great deal of emphasis on revenue growth in emerging markets. Since these markets are smaller than in developed countries, the number of product dossiers to be managed has grown significantly. Industry consolidation only adds to the amount of documents managed by each company.
Additionally, the industry is focused on cost improvements which manifest in two ways.
>Manufacturing and supply chain organisations are driving to reduce costs and are generating changes to achieve those cost reductions. Secondly, CMC organisations have limited headcount and cannot effectively handle the changes as they are processed. To date, companies have largely focused on improving the process for managing CMC changes. While they have most certainly seen progress, they have been attacking the wrong problem. The issue at hand is the volume of change; too many changes are being forced through a system is not built to manage the load, and in today’s environment, with limits on headcount and costs, ramping up capacity is not a viable option.
>In short, the old method of dealing with change is no longer up to the task. Pharma executives looking to stay ahead of the curve should examine their options and remember Einstein’s observation; it is time to take a new approach that counters the myriad market challenges through simplified, scheduled releases.
A new outlook on change
A “version release” model – as tested and proven by the software industry – serves as an interesting starting point. Companies should move away from the routine of considering changes on an FIFO basis in favour of a scheduled cycle of submissions. That will effectively break the change control process in two, separating change initiation and approval from change implementation.
This approach allows for the idea creation and evaluation process to progress unhindered as it promotes continuous improvements. At the same time, it reduces the number of changes (and costs) that are being processed by the organisation, which allows for closer control of the new product version and less opportunity to fall out of compliance.
Version release is especially relevant given the constantly shifting and fragmented global regulatory environment. Indeed, in January 2010 the EMEA ‘Variations Regulation’ (Commission Regulation1234/2008) introduced the concept of bundled variations for changes to centralised procedure and MRP/DCP marketing authorisations. Companies following this regulation can organise and bundle changes in a manner that the Board of Health is expecting, reducing the cycle time for review and approval.
Reduce the burden
When changes are considered in scheduled batches, the process separates the frenetic pressure of ad hoc idea generation from implementation.
Simply put, there are fewer submissions which mean fewer documents to author and publish and fewer changes to track – by the thousands. This will allow the strategist to focus on and optimise each submission. By pre-scheduling the submission throughout the year, the authoring and submissions groups can predict the level of activity and level load resources. This level loading also promotes effective use of outsourced resources for these functions.
Also, by evaluating multiple changes as a group, the version approach will be particularly useful when these changes impact the same documentation, thus eliminating overlapping changes.Lastly, fewer submissions mean less tracking and much less complication when releasing products to markets.
Promote context and clarity
While the traditional method of submitting individual changes makes each change simpler to author and explain, when these requests are submitted on a FIFO basis, regulatory agencies gain little explanation of the interaction between them.
Version release, however, allows companies to portray a more thought out and complete picture to the regulatory authorities. The presentation of the overall change enables better decision making, and is infinitely preferable to the scattered insight gained from 20 isolated submissions.
In addition, with this level of context, leaders can more easily determine when changes call for immediate intervention based upon new requirements, quality or compliance issues. These cases can trigger a bypass program that circumvents the schedule and leaps to emergency implementation.
Improve the way changes are seen by the company
As the new process is ingrained in the company, each product will be assigned a release schedule for changes. As stakeholders adapt to a published schedule, they will become aligned as to when and how changes should be entered into the submission process. The discussion then shifts from “when can we implement this change,” to “in which release can this change be included” – an important distinction as implementation timing falls to the groups which are originating and benefiting from a change.
Tackling the change
In the future state, manufacturing and supply chain organisations will continue to generate change requests as good ideas surface. Change Control Boards, as part of the evaluation, will decide which version to include the change. CMC organisations will have a fixed schedule of changes. At the appropriate time, they will gather all of the approved changes, develop the submission strategy for the combined change, and update all the submission documents which will significantly reduce their workload. Country offices would then process fewer submissions that are based upon a fixed schedule. Health Authorities will see fewer, but more thought out submissions, allowing them to evaluate the combination of changes rather than piece together a series on individual changes. Lastly, having fewer versions will make it easier for supply chain and quality organisations to release and distribute the right products to the right markets.
The evolution to a new change platform begins with a thorough assessment of the number and types of changes, the processes in place for submission and implementation, and up to ten products best suited to serve as a pilot group for version release. If an annual schedule is too much of a change, a frequency of twice a year may be a better starting point.
The approach will ensure the implementation of the most impactful changes while reducing the number of changes, costs and resources required to manage those changes. In the long term, companies will enjoy an improved state of compliance, lower cost product, and a structure more geared to the modern, global environment.
David Lerner is a healthcare strategy expert at PA Consulting Group