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Susan J. Schniepp is a fellow at Regulatory Compliance Associates, Inc. and a member of Pharmaceutical Technology's Editorial Advisory Board.
We never thought implementing complex changes could become more cumbersome.
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.
Susan J. Schniepp
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.
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.
Figure 1: Change complexity versus change implementation. (FIGURE IS COURTESY OF THE AUTHOR)
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, firstname.lastname@example.org