The Future of CGMP: Digitalization’s Role in Compliance and Quality Control - Insights from the FDA

In a recent panel discussion, an FDA representative highlighted how digitalization is shaping the future of current good manufacturing practices (CGMP). Over the past two decades, both the FDA and the industry have discussed the gradual integration of technology in CGMP, and today, the “current” in CGMP truly means embracing these advancements. Here are some key takeaways on what digitalization means for CGMP compliance and the expectations for quality management.

Embracing Digitalization While Remaining Flexible

One of the essential points made was that the FDA’s CGMP guidelines are format-neutral; there’s no specific mandate to use paper or digital systems. Interestingly, while the term "paper" doesn’t appear in CGMP documents, “computer automated” is mentioned over 20 times. This lack of prescribed format allows manufacturers flexibility in their approach—whether digital or paper-based—as long as their systems ensure quality and compliance. The focus is not on the medium but rather on how the system, whether digital or manual, supports reliable quality outcomes.

Quality Over Format: Digital Systems Are Not Automatically Superior

Digitalization is often seen as a leap forward, but it doesn’t automatically equate to better quality or compliance. The FDA has observed both exemplary paper-based systems and inadequate digital systems. The effectiveness of a system depends on whether it’s well-controlled and aligns with quality objectives, rather than on its digital or paper-based nature.

A point of caution raised during the panel was that digitizing an ineffective or poorly managed process doesn’t inherently improve it. If you automate a flawed system, you simply end up with a “bad automated process,” which the panel coined as “BAMP” rather than “GAMP” (Good Automated Manufacturing Practice). This underscores the importance of implementing controls, visualization, and other digital tools thoughtfully, with a focus on enhancing the underlying quality processes.

Digitalization as a Growing Expectation for CGMP Compliance

Despite the flexibility afforded to companies, the FDA recognizes that digitalization is increasingly becoming the standard for modern manufacturing environments. Although not yet required, there is an expectation that manufacturers embrace digital tools to meet today’s operational and quality demands. Technologies that enhance visualization, standardization, and risk assessment will likely become essential for compliance over time.

The agency’s stance is that while digitalization may not yet be mandatory, manufacturers should prepare for a future where maintaining traditional paper systems might raise questions about risk management and quality control. For instance, digital tools allow for advanced data visualization and provide real-time insights that can be integral to quality decision-making. This additional layer of control and transparency could eventually become a compliance expectation as technology continues to evolve.

Digital Transformation with Quality in Mind

The FDA panelist emphasized that digital tools should be seen as drivers of quality. The primary aim of any CGMP-compliant system is to ensure that every process is within control, contributing to safe, effective, and high-quality products. Moving toward digitalization should reflect this commitment to quality, using the tools to support—not replace—sound quality management principles.

In conclusion, the FDA’s view is clear: while digitalization isn’t yet a requirement in CGMP, it is a powerful tool for enhancing quality assurance and regulatory compliance. Companies are encouraged to adopt digital tools that add value to their quality systems and to anticipate a future where these technologies may become an expected component of CGMP compliance. As we approach 2025, the FDA is signalling that the industry should be prepared for this gradual but inevitable transformation, integrating digital tools that not only streamline processes but fundamentally support a commitment to product quality and safety.