Learning Good Documentation Practices
If you’ve tried Googling the FDA requirements for Good Documentation Practices (GDP), you’ll find that they don’t exist because it’s an expected practice and not a Code of Federal Regulations (CFR) requirement. At best, you can find a few references in the Medical Device Quality Systems manual (Section 9) and ICH Q7A (Section IV-A).
Typically, when someone uses the term good documentation practices, it’s in reference to entering data or making corrections to a controlled record. However, there are other aspects of good documentation practices that include the formatting of controlled records, signatures and approvals, and document hierarchy. This article focuses on how to enter data or make corrections to a controlled record.
The purpose of good documentation practices is to clearly document what actions took place in the development or manufacture of a drug, biologics, vaccine, medical device, etc. so that anyone, including an auditor, has documented evidence that you did exactly what you said you did. Keep in mind that a controlled record is considered a legal document, so the data needs to be clearly documented for legal and preservation purposes. In the Biotech Industry we apply good documentation practices with every record or document and require a review of the principles during your new hire training. There’s a saying that’s drilled into you from day one ‘If you didn’t document it, then it didn’t happen’.
Entering Data Into A Controlled Record
Apply the following practices when you’re entering data into a controlled record:
Use indelible (water-resistant) blue or black ink so that it doesn’t fade over time or smudge if it gets wet. No pencils or felt-tipped markers allowed
Enter data directly in the controlled record and never on a piece of scrap paper in the interim
NEVER back date!
Make sure the entries are accurate and legible so that anyone can understand your entries
Document dates in a standardized format as specified in your Standard Operating Procedure
Draw a diagonal line through any blank fields or empty spaces at the bottom of a page and include ‘N/A’ along with your initials and date. Blank fields can be interpreted as missing data and empty spaces at the bottom of a page (e.g. lab notebooks) can give someone the opportunity to add data without your knowledge or consent.
Number each page in a controlled notebook chronologically. This verifies that no pages are missing
Paginate attachments (e.g. page 1 of 10)
For instrument printouts, adhere with clear adhesive tape and include your initials and date where the printout is attached so that part of your initials/date will be on the attachment and part will be on the notebook
When entering repetitive data, do not use ditto marks
Making Corrections To A Controlled Record
Apply the following practices when making corrections to a controlled record:
Draw a single line through the information that needs to be corrected, making sure not to scribble out the original data, use white out or write over data (e.g. turn a zero into the number nine) because it hides the original data
Briefly state what’s wrong with the information (e.g. wrong date) and document the correct information
Initial and date when the corrections were made
NEVER back date. This is so important that it’s mentioned twice!
Changes or additions to records post approval require the document go through the approval process again
Although good documentation practices are typically found in FDA regulated industries, it’s certainly beneficial for any industry to adopt these practices.
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