You got mail! It's a warning letter...

February 9, 2023
Dr. Daniela Pedersen

62 times in 2022 an executive charged with managing a cGMP facility sipped their morning coffee and noticed a piece of mail with an ominous return address.

They read the address again, just to be sure. Could this really happen to us? This couldn’t happen to us.

Warning Letter 110-28-03

January 31 2023

Dear CEO,

The U.S. Food and Drug Administration (FDA) inspected your facility, Company Facility, FEI 1008529654,at 100 Bridge Street, Cambridge, MA from December 01, 2022.

This warning letter summarizes significant deviations from Current Good Manufacturing Practice (CGMP) for active pharmaceutical ingredients (API).

About once a week a company responsible for adhering to GxP regulations and guidelines will receive a publicly available letter like this. No one’s exempt—large multinational biopharmaceuticals, cutting-edge biotechs, or contract manufacturing organizations—this disrupts operations, damages brand reputation, and consumes resources and capital. Every day a product is delayed in time to market, the company forfeits 1 million dollars.

GxP compliance = good science + good data

GxP is a must. The regulations and guidelines exist to ensure that biopharmaceutical products are safe, meet their intended use, and adhere to quality processes. Today, the FDA is shifting much more attention to data and how it’s produced, processed, and used for the development of products.

Consider key aspects of GxP data regulations and guidelines:

  • Traceability - Ensuring records from each stage of the production process can be found and and linked back
  • Accountability - Identifying which individual did what and when in each stage of the production process
  • Data integrity - Ensuring the reliability of data by ensuring it isn’t modified, tampered, or deleted

Together, these requirements help biopharma organizations ensure and demonstrate that their therapeutics are safe and effective. And it helps them avoid warning letters (…remember those?).

“Non-value-add” compliance efforts

Typically, GxP compliance efforts require substantial time and money. Also, typically, scientists and operators don’t perceive these efforts as having value. This can put companies in a bind as they strive to deliver products to market as fast as possible with controlled costs, all while remaining compliant.

However, before shaking the proverbial stick at regulatory bodies, it may be worth considering that out-of-date technology and archaic data processes are really what’s impacting efficiency and driving up costs.

Paper-based systems are surprisingly common, even at industry leading organizations. While these systems can still achieve compliance, they’re anything but FAIR, transparent, or easily shareable. At the same time, it is difficult to achieve and prove traceability, accountability, and integrity, not to mention that these processes are extremely error-prone.

Let’s not just blame paper-based systems; electronic systems also have their challenges. Systems, databases, and processes are typically disconnected. Data silos and proprietary data formats limit data transfer and reuse. The manual copy-and-paste labor required to enter data is error-prone, requires time-consuming human review (four eyes principle), and makes the entire regulatory compliance process cumbersome and costly. It is also a complete slog.

Therefore, the real non-value-add work is not regulatory compliance per se but the labor needed to prop up inefficient systems and old, disconnected technology.

How to make achieving GxP compliance easier

Integration and automation make achieving GxP compliance easier

It’s truly tempting to reach for a next-gen software solution and call it a day. But GxP compliance cannot be achieved by simply deploying fancy new software, even if that system is a modern quality system to manage documents or quality processes like deviations, CAPAs, or audits. These alone are not enough. GxP compliance and especially 21 CFR Part 11 require a deeper understanding of the actual scientific data, the data workflow, and where data issues arise.

Organizations need to embrace data strategies that help scientific data achieve traceability, accountability, and data integrity throughout the data lifecycle. Digitalization and data-centricity by design are the answers.

One key aspect of digitalization is automation. One can quickly improve several aspects of data collection, contextualization, and storage.

  • Integration with automated data transfer eliminates error-prone, costly, and time-consuming manual data movements (data integrity)
  • Automated metadata enrichment will provide context of the data including who generated the data (accountability) while enabling easy data retrieval (traceability)
  • Automated data centralization finally rids laboratories of USB sticks and other cumbersome, insecure data storage (data integrity and traceability)

Another aspect you should prioritize is accessibility. To ensure all records of the production process are traceable requires that they are accessible and have appropriate metadata. With additional data harmonization you can also compare and visualize data across every stage of the production process. This enables you to optimize product quality as well as yield.

Also look at including rigorous controls and audit trails. Every user must have (and use!) individual logins. Meanwhile, audit trails reliably track who is working on the data and log when, or if, something has been changed. This supports accountability and traceability and helps you easily answer questions during an audit.

A solution that is data-centric by design and provides these capabilities for scientific data can radically decrease the level of “non-value-add” GxP compliance efforts—and minimize the chance of receiving an ugly letter from the FDA.

Data-centric GxP compliance with TetraScience

Maximizing automation, ensuring accessibility, and enabling rigorous controls over scientific data across the entire production lifecycle is difficult to achieve without a data-centric approach.

The Tetra Scientific Data Cloud™ is the world’s first and only scientific data cloud specifically designed with life science industry standards in mind. It fulfills GxP requirements with its validation-ready, automated integrations and cloud storage. It can also automate metadata enrichment and provide users with absolute clarity and control about where their data is coming from, who is interacting with it, and where it is going.

TetraScience supports 21 CFR part 11, EU Annex 11, GxP compliance, and helps customers reduce GxP related efforts.

To learn how TetraScience can help you avoid unwelcome mail, read our GxP solution brief.