What’s the right way to make a correction to a document that is covered by GMPs?

The FDA is focusing closely on data falsification during inspections – that means both intentional fabrication of data and mistakes. One of the most common documentation mistakes employees can make is in the process of correcting a document that contains an error. You can correct GMP documents, but you have to do it the FDA way:

1. Place a single line through an incorrect entry, leaving the incorrect data legible;
2. Enter the correct data next to the mistake;
3. Place initials next to the correction and the date the correction was made.

As always, check with your own SOPs to see who must be informed of and approve the correction. Following these steps will allow you to maintain accurate records, but provide the trail the FDA requires to avoid any appearance of covering up a problem.

For more training on documentation issues, see our Good Documentation Practices e-learning program.