October 26, 2022

GDP for GMP – Black or Blue Ink?

It has been said that in the medical device and pharmaceutical industries, “If it isn’t documented, it didn’t happen.”

Therefore, we document to provide written proof that something happened. For this reason, good documentation practices (GDPs) are crucial for maintaining compliance and quality. Failure to comply with GDPs can lead to data integrity risks, security and safety risks, as well as current Good Manufacturing Practices (cGMP) audit failures.

Real-Time documentation of production events represents the only true record of:

• Batch processing

• Device production

• Batch or product release or rejection

• Corrective actions or preventive actions (CAPAs)

• Deviations or production non-conformances

In addition to regulatory requirements, it is also important to maintain accurate records for quality assurance purposes. Maintaining accurate records gives manufacturers the ability to pinpoint issues throughout production, allowing them to make quality improvements as necessary. Organized records also assure regulators that manufacturers are documenting their production processes in real-time.

There is no industry-specific GDP requirement to follow. However, ISO 13485 and 21 CFR 820 require documents to be legible, hence GDPs are essential for attaining and sustaining ISO certification. In addition, GDPs are enforced by regulatory agencies such as the FDA, TGA, and Health Canada.

GDPs apply to everyone who documents activities related to cGMP. Compliance with the Food and Drug Administration’s Good Laboratory Practices (GLP), regulations (21 CFR Part 58), as well as GMP regulations for drugs and medical devices (21 CFR Parts 211 and 820), requires the use of GDPs.

What does a GDP look like? Well for example, it could come down to the type of ink you use on your documentations. While there is no industry specific requirement to use black or blue ink, whatever type you choose should remain consistent with what is specified by a site’s standard operating procedures. For instance, an auditor will probably notice if they read within a site-specific SOP that only black ink is acceptable for hand-written remarks on forms, but when they begin auditing hand-documented forms, they’re looking at nothing but hand-written blue ink.

There are arguments to be made about what ink type is superior. Blue ink can help to distinguish original signatures from printed replicas, while some believe blue ink is unable to reliably produce photocopies. But in this case, it is more than about choosing the superior ink. It is about being consistent in the records you provide to ensure you are following good documentation practices.

Now I know what you might be thinking. Are we really discussing ink color in 2022? While this information may seem irrelevant in today’s day and age the same general concept still applies. You will have to decide the best practices to ensure records are clear and consistent in a digital format. It is critical that manufacturers understand the FDA’s Guidance on electronic records, 21 CFR 11, and the EU’s approximate counterpart, Annex 11. These guidelines are central to understanding medical device manufacturers’ electronic data regulation requirements in the EU and the U.S. So even if you don’t have to worry about what color ink you are using, there are still requirements that are necessary to follow regarding your digital records.

To better understand the expectations of and differences between the EU’s Annex 11 and the FDA’s 21 CFR Part 11, check out Annex 11 & Part 11: What’s the Difference?

Whether it is black ink, blue ink, or digital record keeping, Prime Path Medtech™ is happy to consult with firms to ensure all their site-specific documentation practices maintain compliance with regulations. Contact us today to find out how we can assist you in your efforts.