How to manage GxP systems across production sites without getting bogged down in details

The Challenge of Global Compliance Management

As pharmaceutical companies grow and expand global production sites, the management of GxP systems often becomes a significant challenge. The balance between ensuring global compliance while considering local conditions can be difficult to achieve. Many companies find that management either becomes too bureaucratic and cumbersome or too lax, risking compliance issues.

The biggest challenge lies in maintaining consistent standards globally, while allowing for local flexibility. Local regulations and practices can vary significantly, and without an effective global governance structure, one can quickly end up with a complex and inefficient system that is hard to navigate.

Consequences of Poor Global Governance

If governance of GxP systems is not handled effectively, the consequences can be severe. The company may face compliance issues, leading to sanctions from regulatory bodies like the FDA and EMA. Additionally, there can be poor morale at local production sites if they feel that global requirements and procedures do not take into account their individual day-to-day operations and situations.

Another challenge is that ineffective governance can lead to wasted resources. Companies risk expending too much effort on unnecessary bureaucracy and details that do not provide real compliance value. This can negatively impact productivity and, in the worst case, lead to quality issues because the focus shifts away from core tasks.

Effective Strategies for Global Governance

To ensure effective global governance of GxP systems, it is important to establish a clear yet flexible framework. This involves defining a global governance model that sets forth clear minimum requirements while also allowing for local adaptation.

A good approach is to create a clear distinction between global standards and local procedures. Global standards should be simple, clear, and easy to understand for all production sites. Local procedures can then be developed within this framework, ensuring they comply with global requirements while considering local conditions.

Another important strategy is continuous communication and collaboration between global governance teams and local production sites. By regularly involving local teams in the development and updating of global standards, one ensures that the standards are relevant and practically applicable. This also fosters greater understanding and acceptance of global requirements among employees.

It is also crucial to have an effective reporting system that allows for monitoring compliance globally without unnecessary complexity. This can, for example, be achieved using central digital tools that provide management with oversight without drowning employees in detailed reports.

If you want to learn more about how to best manage GxP systems globally without falling into unnecessary complexity, feel free to reach out to us for an informal discussion.