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

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

Hello there!:bigwave::bigwave:

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?

found these on FDA web sites

http://www.fda.gov/ohrms/dockets/dockets/04n0115/04n-0115-c000006-02-vol8.pdf

(search for GDP)


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

hope they help

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/detnews.asp?articleid=21085&sectionid=50

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.

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

Have you read DOCUMENT AND CHANGE CONTROL (http://www.fda.gov/cdrh/qsr/09docnt.html) from the FDA Quality Systems Manual? (http://www.fda.gov/cdrh/qsr/09docnt.html)

kmuela, welcome to the cove.

I have been in the industry and document control for about 8 years. I know that I have found myself using the term "good documentation practices" however, I have never seen any specific regulation from the FDA that covers it in detail. When I refer to good documentation practices I am usually referering to the industry standard (i.e. what other companies are doing) and the general regulations 21 CFR 58, 21 CFR 211, and 21 CFR 820. Essentially good documentation practices are documenting you actions in detail (so that a third part would know what happened) and properly signing & dating (or initialing) entries, and making corrections so that all data is legible, no white out, etc. My company has a procedure that defines what is appropriate documentation, formats for dates, formats for corrections etc. The procedure helps standardize what the expectations are for all employees.

I agree also.. I have a standard document that defines the white out and "write over" issues on all quality system documentation. Since everyone is trained to this specific document I have evidence that they are aware of the requirment. If someone else is quoting GDP.. have you asked them to show you a document? I have experience people quoting things that aren't truely related or misdirected to a standard which can cause more harm than good..

tata:confused:

This is a sample found in the web: Good Documentation Practices Policy (http://pscclinical.com/index.php?option=com_content&task=view&id=14&Itemid=21)

Thank you very much for taking the time to find this. It looks like there is nothing "official" out there, but some common sense practices that have been shared and accepted.

Thanks again,

KMuela:thanx:

I am going little bit out of topic here.....

If your company is certified for ISO 13485:2003 then it is very easy for you to have the proper documentation in structure

I am attaching you document which clearly depicts the correlation between the ISO 13485:2003, GMP guidelines

I am going little bit out of topic here.....

If your company is certified for ISO 13485:2003 then it is very easy for you to have the proper documentation in structure

I am attaching you document which clearly depicts the correlation between the ISO 13485:2003, GMP guidelines



Wow, Regulatory. I am flattered, that you would pass on the matrix that I made, that must mean that you found it useful. :)

By the way, unless your blog contains information that the users of the Cove would find useful, then please refrain from linking it.

Wow, Regulatory. I am flattered, that you would pass on the matrix that I made, that must mean that you found it useful. :)

By the way, unless your blog contains information that the users of the Cove would find useful, then please refrain from linking it.

Yes, we would prefer that you locate the link of your blog in your profile and reference it when necessary.

I am looking for a visual aid that illustrates the good practices for changing a quality record when a mistake is made. I also would like to illustrate the bad practices so that the field folks can really understand whether their corrections are adequately documented.

Hi, I am familiar with what is referred to as Good Documentation Practices. In fact, I was just about to review the SOP on it and wanted to look around first for anything new and happened upon this chat. So you won't feel alone, http: compliance online.com and follow to training.
Also try ICH Q7A, which includes a short section on documentation of changes to douments. You may also look at ALCOA: Attributable, Legible, Contemporaneous, Original, Accurate. It is all related to GMP.

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
Nothing from FDA, per se. We have a complete manual on Quality Systems, including QSIT and other materials. visit my web site and click on "books"

Ken Reid

Like others, I agree that there is no specific FDA "GDP" expressed as such. The reference posted by Al, albeit a decade or more old is still as complete a reference as you'll find on FDA's expectations regarding "Good Documentation Practices":2cents: