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 incredible institution and not a Code of Federal Regulations (Cfr) requirement. At best, you can find a few references in the medical device quality Systems hand-operated (Section 9) and Ich Q7A (Section Iv-A).
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 comprise the formatting of controlled records, signatures and approvals, and document hierarchy. This record focuses on how to enter data or make corrections to a controlled record.
Science Current Event Articles
The purpose of good documentation practices is to clearly document what actions took place in the amelioration or form of a drug, biologics, vaccine, medical device, etc. So that anyone, together with an auditor, has documented evidence that you did exactly what you said you did. Keep in mind that a controlled record is carefully a legal document, so the data needs to be clearly documented for legal and preservation purposes. In the Biotech commerce we apply good documentation practices with every record or document and require a characterize of the theory 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 definite and legible so that whatever can understand your entries Document dates in a standardized format as specified in your approved Operating Procedure Draw a diagonal line through any blank fields or empty spaces at the bottom of a page and comprise '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 person the opening 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 comprise 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 primary data, use white out or write over data (e.g. Turn a zero into the whole nine) because it hides the primary data Briefly state what's wrong with the information (e.g. Wrong date) and document the definite information introductory 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 require the document go through the approval process again
Although good documentation practices are typically found in Fda regulated industries, it's indeed useful for any commerce to adopt these practices.
(c) 2009-2010 Copyright
learn more studying Good Documentation Practices
No comments:
Post a Comment