Is there such a thing as FDA Good Documentation Practice (GDP)?

[kmuela]

Is there such a thing as FDA Good Documentation Practice (GDP)? This is often referred to at my new company. If not, is anyone aware of a specific general guideline for it elsewhere? I have tried numerous web searches, with many references and general comments on a single instance of a good documentation practice, but I can't find a single, official document for "GDP" overall.

Thanks,

KMuela

[Ana Senutna]

I just googled it. You will come up with lots to look at.

[BradM]

Hello there!

Two first-time posters back to back! We're really glad to have both of you here.

KMuela, when I first saw your question, I thought it was going to be a simple one. Well, after looking around a bit, I realized the purpose of your question. I too, cannot find a direct FDA document related to Good Documentation Practices. I know it exists, but I cannot find it.

Covers, can any of you help KMuela (and me) with a reference document?

[madannc]

found these on FDA web sites

http://www.fda.gov/ohrms/dockets/doc...06-02-vol8.pdf

(search for GDP)


http://www.fda.com/forum/showforum.php?fid/23/

hope they help

[madannc]

After a bit of surfing it appears that GDP is Good "Distribution" Practices and Documentation would be covered by cGMP

Good Distribution Practices (GDP) is the latest mandatory requirement in the WHO (Geneva) current Good Manufacturing Practices (cGMP) guidelines. cGMP is the upgraded version of GMP. The WHO GMP certification is mandatory for any Indian company that wishes to export its products to the semi-regulated markets.

From http://www.pharmabiz.com/article/det...5&sectionid=50

[kmuela]

Thanks for your reply, but I truly am looking for Good Documentation" Practice...at my new company this is a frequent refrain from the Document Control group...I'd like to review any specific regulations or guidelines, but can't find any.

[kmuela]

Thanks so much for taking the time to look, but I really did mean Good "Documentation" Practice.

[Al Rosen]

Have you read DOCUMENT AND CHANGE CONTROL from the FDA Quality Systems Manual?