Documentation as we have said before is the eyes of the FDA! To prove your compliance: document, document, document.

GDP is important because we have to have to be able to trust that the information is correct. Adhering to GDP helps prevent errors within various processes, such as product quality and safety, state of manufacturing facilities and other related activities, and ensures that each company is following strict standard operating procedures (SOPs).

In a regulated industry, quality cannot be assured without accurate documents and GDP. Strict compliance with GDPs will help a company establish consistent practices that will minimize risk of misinterpretation, errors in communication and ensure product quality. Following good document practices is not only an essential aspect of compliance with federal regulations, but also critical to consumer health. I know some of these seem arbitrary and capricious but think about this.

According to a Jan 2007 Time magazine article

> "Doctors' sloppy handwriting kills more than 7,000 people annually. It's a shocking statistic, and, according to a July 2006 report from the National Academies of Science's Institute of Medicine (IOM), preventable medication mistakes also injure more than 1.5 million Americans annually. Many such errors result from unclear abbreviations and dosage indications and illegible writing on some of the 3.2 billion prescriptions written in the U.S. every year."

What if those medical professionals were held to the same GDP standards the way the manufacturers of the medications they are prescribing are? 7000 fewer dead and 1.5 million fewer injuries a year! Just to put that into perspective in 2006 when this data was collected 1.5 million people was close to 5% of the population of the USA or close to 50% of the population of Utah. That is the kind of impact on patient health and safety GDP can have for good or ill.

Learning Objectives:

- 2.4 - Complete appropriate documentation using good documentation practices contemporaneously to making a product.