GAMP 5 guidelines and the FDA’s CSA guidance: their necessity and the case for quality

Stephen Ferrell Date published: Jan 23, 24

Regulation in life sciences is becoming increasingly complex, especially when it comes to the application of computerized systems. Guidelines like ISPE’s Good Automated Manufacturing Practice (GAMP) and the FDA’s Draft Guidance on Computer Software Assurance (CSA) are providing the industry with comprehensive frameworks for risk-based computer system validation and assurance.

The GAMP guidelines and the FDA's draft guidance work hand in hand to foster regulatory compliance, high quality, and suitability for all GxP applications. It's about maintaining a delicate balance between ensuring rigorous regulatory compliance and avoiding extensively rigid validation requirements that may stifle innovation.

This article serves as a summary of the contents of our recent whitepaper on the case for quality and the necessity of GAMP5 2nd Ed. and the FDA’s CSA guidance. If the information below is useful, you will find a link to download the full whitepaper below, and at the end of the article.

The distinction between validation and assurance

Although the two concepts overlap, validation and assurance are two distinct entities. While validation involves thorough testing, documentation, and change control to ensure a computerized system meets its intended use, assurance is about maintaining confidence that these systems can reliably keep their validated state. It goes beyond exhaustive documentation and focuses more on risk-based vigilance.

GAMP5’s pragmatic principles

GAMP5's principles, updated in July 2022, address the dynamic and digitally driven nature of the life sciences industry. They advocate for an efficient, innovative, and balanced approach to governance. One of the key features of GAMP5 includes an increased reliance on service providers for enhanced system development and maintenance. It also promotes adaptive methodologies for software development, critical thinking, and risk-based governance.

However, the industry still battles with overly conservative interpretations of GAMP and FDA expectations. This often results in excessive documentation, testing beyond risk-justified levels, and inflexible control processes, which can hinder progress and innovation.

FDA's perspective

The FDA’s 2023 Draft Guidance on Computer Software Assurance re-emphasizes the need for balance. It advocates for a risk-based approach in establishing confidence in automated production or quality systems. The level of assurance activities needed is determined by assessing the risk of software failure and its potential impact on safety.

The draft guidance recommends shifting from a focus on documentation to a focus on critical thinking and risk-based decision making. This approach allows companies to better allocate their resources, spending less time on low-risk systems and more time on high-risk systems that could impact product quality, data integrity or patient safety. By encouraging a culture of continuous improvement rather than compliance for its own sake, the FDA’s CSA approach promotes technological innovation and progress in the life sciences industry.

The shared vision: a balanced approach

Both GAMP 5 and the FDA's CSA guidance share the vision of a balanced, effective approach to computer system validation and assurance within the life sciences industry. While GAMP 5 provides the industry with a detailed, risk-based methodology for the validation of GxP automated systems, the FDA's CSA guidance complements these validation efforts with an emphasis on assurance. This assurance is achieved by evaluating the criticality and potential impact of any software failure, thereby guiding the appropriate level of assurance activities.

The common thread is an emphasis on risk-based strategies. This approach is not about eliminating all risks but rather managing them in a way that is proportionate and appropriate. This involves making informed decisions about resource allocation and applying control measures where they can have the most significant impact. In doing so, the guidelines aim to ensure regulatory compliance without restraining innovation and progress in the industry.

However, proper interpretation and application of these guidelines remain a challenge. Overly conservative methods can result in excessive and unproductive documentation, over-testing, and rigid control processes. The goal for the industry should be to leverage these guidelines in a way that promotes efficiency, flexibility, and growth.

The need for proactive, balanced innovation cultures

GAMP5 introduces an innovative model for quality culture, emphasizing balance across compliance, quality and change for patient benefit. This model encourages companies to adopt cultures grounded in critical thinking, scientific inquiry and pragmatic risk principles.

However, the ultimate objective remains patient well-being. Companies should uphold their commitments to excellence by focusing on transformative solutions and risk management principles, rather than just ticking off documentation checklists.

The Call for proactive progress

In conclusion, life science leaders must prioritize the pragmatic interpretation of regulatory guidance. This involves embracing GAMP5’s principles to provide a blueprint for governance that combines the strengths of stakeholders while assuring quality. The future of life sciences is full of potential for those willing to take purposeful action, with a focus on patient priorities and the assurance of transformative solutions. 

Want to learn more about GAMP5?

Watch the webinar with Ideagen’s Stephen Ferrell, an ISPE GAMP5 second edition contributing author as he shares some of the key updates to ISPE's definitive guide to computer system validation and software assurance.

Watch on demand

References
ISPE. (2022). GAMP5 Second Edition Guide: Compliant GxP Computerized Systems.
FDA. (2023). Draft Guidance for Industry and Food and Drug Administration Staff - Computer Software Assurance for Manufacturing, Operations, and Quality System Software.