Enhancing Compliance Through Process Leadership

Sandberg, Vice President Global Quality, Centrient Pharmaceuticals

Sandberg, Vice President Global Quality, Centrient Pharmaceuticals

Pharma businesses are becoming more and more complex. The number of partnerships, mergers and acquisitions are growing and the use of virtual supply chains is increasing. These developments require a much stronger and more aligned global approach to good practice (GxP) quality compliance.

A global company that operates in various continents, using both internal and external supply chains and selling products in both large, developed economies as well as emerging markets is very complex to manage from a GxP point of view. Such a company is at risk of the quality management system becoming misaligned and fragmented and may damage the company’s reputation with regulators and customers.

Process leadership is a very strong tool to secure efficient, compliant, and globally aligned processes regardless of locations and markets. With a quality management system built on the principles of process leadership, the standard operating procedure (SOP) hierarchy is built horizontally without dependencies on organizational structures. This means that if the organization changes its structure or goes through merger and acquisition activities, the key quality processes are sustained and remain controlled.

As an example, a process like “deviation investigation and corrective and preventive actions (CAPA) management” applies to the entire company and is not linked to any specific function or department. The process should therefore be managed by a process lead and a cross-functional process team. In that way, the process is globally aligned, and the process lead has the mandate to ensure that the process is continually reviewed and actively optimized and maintained.

"When introducing process leadership, one should first develop the ‘process landscape’ of the company.”

When introducing process leadership, one should first develop the “process landscape” of the company. The process landscape is a map of all key processes in the company. Typically, the landscape will be built with three layers: management processes, core processes and supporting processes. Management processes could include for example organizational development, financial planning, and quality management review. Core processes would typically entail product development, life cycle management, sourcing, production, supply and post market surveillance. Supporting processes could be quality assurance, legal processes, human resource processes and others.

Navigating the company’s quality management system from the process landscape and not by departments or functions, educates the organization to apply process and enterprise thinking rather than promoting silo thinking and local suboptimization. It helps the company to become globally aligned with a strong governance structure.

When appointing process leads and process teams, the accountability, mandate, and responsibility become clear. With a stronger process governance, redundant and localized SOPs are avoided, and the quality management system can be kept lean and simple. Such a lean and simple quality management system that is easy to navigate ensures strong compliance and adherence to standards.

In order to emphasize the importance of process thinking, it is important that the roles of process leads and the existence of the process groups are formalized. Process lead roles must be documented in job descriptions and the development of the processes should be rewarded through the company’s performance management system. This brings clear benefits: focus is maintained and the incentive structure supports process thinking company-wide.