Susan J. Schniepp
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Mergers, acquisitions, outsourcing, globalization, downsizing, and new technology. In other words, the pharmaceutical industry
is undergoing immense change. The environment today is one of merging and emerging cultures as companies combine workforces and globalize processes to
be able to compete in the global marketplace.
Merging companies must not only integrate their products but also their cultures—all while shrinking costs and maintaining
control over their quality systems and regulatory compliance. Add to the mix the introduction of new technologies, which small
and sometimes virtual companies must also manage within their quality systems across a variety of service providers and partners.
With all of these changes, the criticality of an efficient change-control system that can track and ensure proper evaluation
and implementation of changes is obvious.
Figure 1: Change complexity versus change implementation. (FIGURE IS COURTESY OF THE AUTHOR)
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Envisioning a change-control system as a graph with ease of implementation on the X-axis and the complexity of the change
on the Y-axis, it becomes easy to visualize why some changes may take years to implement (see Figure 1). As a change becomes
more complex (e.g., a change that involves multiple products and country registrations), it becomes harder to implement. Complex
changes are difficult enough for a single company with multiple sites, but they are even more exaggerated for virtual companies.
For the latter, multiple contract service providers are often involved and each one has its own processes and procedures
for managing a requested change.
Types of changes
Overall, changes can be categorized into four distinct levels of complexity: Level 1–Basic Change, Level 2–Straightforward
Change, Level 3–Complex Change, and Level 4–Integrated Complex Change.
Level-1 changes tend to be simple and easy to implement (e.g., changing a typographical error on an internal compliance document).
Although these updates may affect multiple sites, there is no impact to regulatory filings or product quality and the changes
do not require retraining.
Level-2 changes are more challenging to implement. This second level of change (e.g., a change to a test method) often applies
to more technical documents and systems. The changes being proposed may require validation activities and may affect multiple
sites. Companies must assess how these changes will impact regulatory filings and product quality and strategize their implementation
accordingly. Consideration should be given to the time required to train all affected personnel.
A Level-3 change is often intricate, involving changes to technical internal documents that effect multiple products at multiple
sites (e.g., a change to a test method for an excipient that is used in a variety of products, which are manufactured at
several facilities). Level-3 changes require personnel retraining at all affected facilities. In addition, the regulatory
impact of these changes may be to multiple registrations in multiple countries with a possible impact on product quality,
which can be time-consuming and difficult to implement.
A Level-4 change is the most integrated, most complex change. These changes can border on arcane and their implementation
can take years to accomplish. They typically involve technical documents that require changes to processes, equipment, and/or
facilities affecting multiple sites and/or multiple suppliers, and require employee training for both the company and supplier
employees. The regulatory impact can affect multiple filings in multiple countries as well as product quality. An example
of an integrated complex change may be the product transfer and subsequent decommissioning of an old manufacturing facility
previously responsible for multiple products.
The time required to transfer, validate, train, and obtain regulatory approval for multiple products requires enormous coordination.
It is important to keep in mind that as the complexity of the change increases, the need for additional resources can also
increase—as can the need to consider automating the change control process. In other words, although simple processes can
be appropriate for uncomplicated changes, they can quickly become over-challenged when applied to the highest complexity of
change.
Dealing with change
In today's environment, it helps to think of change as a continuum. The complexity of the change can impact the strategies
for implementation, the tactics needed to effectively implement the change, and the time it takes for a change to be approved.
At the same time, manufacturers will need to establish consistency in their regulatory filings without affecting product
quality.
When dealing with this change, focus on the steps needed to effectively implement the change. Working closely with your contract
research organizations to identify an accurate timeline for completion, including the necessary training required for employees,
can help expedite the time it takes to complete the change request. Coordinating these activities with regulatory requirements
also will help ensure necessary changes are implemented globally in an efficient and effective manner.
Susan J. Schniepp is president of Schniepp and Associates, LLC, sue.schniepp@mac.com
