studying Good Documentation Practices

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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 improbable custom and not a Code of Federal Regulations (Cfr) requirement. At best, you can find a few references in the curative expedient ability Systems by hand (Section 9) and Ich Q7A (Section Iv-A).

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Typically, when person 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 contain the formatting of controlled records, signatures and approvals, and document hierarchy. This narrative 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 amelioration or construct of a drug, biologics, vaccine, curative 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 narrative 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 narrative or document and need a recap of the ideas while 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 narrative and never on a piece of scrap paper in the interim Never back date! Make sure the entries are spoton and legible so that anything can understand your entries Document dates in a standardized format as specified in your acceptable Operating Procedure Draw a diagonal line straight through any blank fields or empty spaces at the lowest of a page and contain 'N/A' along with your initials and date. Blank fields can be interpreted as missing data and empty spaces at the lowest of a page (e.g. Lab notebooks) can give person the opportunity to add data without your knowledge or consent. whole 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 contain 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 particular line straight through the facts that needs to be corrected, making sure not to scribble out the traditional data, use white out or write over data (e.g. Turn a zero into the whole nine) because it hides the traditional data Briefly state what's wrong with the facts (e.g. Wrong date) and document the spoton information preliminary and date when the corrections were made Never back date. This is so prominent that it's mentioned twice! Changes or additions to records post approval need the document go straight through the approval process again

Although good documentation practices are typically found in Fda regulated industries, it's for real beneficial for any industry to adopt these practices.

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