studying Good Documentation Practices

Black Codes Facts - 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 thinkable, institution and not a Code of Federal Regulations (Cfr) requirement. At best, you can find a few references in the curative gadget capability Systems manual (Section 9) and Ich Q7A (Section Iv-A).

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Black Codes Facts

Typically, when man uses the term good documentation practices, it's in reference to entering data or manufacture 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 record 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 improvement or invent of a drug, biologics, vaccine, curative device, etc. So that anyone, along with an auditor, has documented evidence that you did exactly what you said you did. Keep in mind that a controlled record is determined a legal document, so the data needs to be clearly documented for legal and preservation purposes. In the Biotech manufactures we apply good documentation practices with every record or document and require a recapitulate 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 spoton and legible so that anything can understand your entries Document dates in a standardized format as specified in your accepted 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 man the opening 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, bind 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 manufacture corrections to a controlled record:

Draw a single line through the information that needs to be corrected, manufacture 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 spoton information initial 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 indubitably useful for any manufactures to adopt these practices.

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