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

[kmuela]

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

 

[Regulatory]

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

 

[Gert Sorensen]

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.

 

[harry]

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.

 

[Littlethings]

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.

 

[JPMac]

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.

 

[FDAINFO]

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

 

[Watchwait]

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"

 

[bio_subbu]

Yes, there is no section of 21 CFR devoted to Good Documentation Procedures.

If you are a manufacturer; 21 CFR 820.40, the Document Controls portion of Quality System Requirements, (QSRs) is the most pertinent to you:

Subpart D--Document Controls

Sec. 820.40 Document controls.​

​

Each manufacturer shall establish and maintain procedures to control all documents that are required by this part. The procedures shall provide for the following:​

​

(a)Document approval and distribution. Each manufacturer shall designate an individual(s) to review for adequacy and approve prior to issuance all documents established to meet the requirements of this part. The approval, including the date and signature of the individual(s) approving the document, shall be documented. Documents established to meet the requirements of this part shall be available at all locations for which they are designated, used, or otherwise necessary, and all obsolete documents shall be promptly removed from all points of use or otherwise prevented from unintended use.​

​

(b)Document changes. Changes to documents shall be reviewed and approved by an individual(s) in the same function or organization that performed the original review and approval, unless specifically designated otherwise. Approved changes shall be communicated to the appropriate personnel in a timely manner. Each manufacturer shall maintain records of changes to documents. Change records shall include a description of the change, identification of the affected documents, the signature of the approving individual(s), the approval date, and when the change becomes effective.​

​

If your company is involved in performing clinical trials, you may want to read the following:

21 CFR 50.27 Documentation of Informed Consent​

21 CFR 56.115 IRB Records​

​

21 CFR 812.140 Records for Investigational Device Exemptions​

​

The Good Laboratory Practices, (GLPs), also include documentation practices:​

​

21 CFR 58.190 Storage and Retrieval of Records and Data​

21 CFR 58.195 Retention of Records​

 

[linedraw]

You won’t find a detailed definition or explanation for "FDA Good Documentation Practice (GDP)". The reason is that if the FDA specifically defined the practice (GDP) and a company followed the FDA instructions then the liability would be on them (the FDA) if a company failed to meet the FDA requirements this area. Imagine a company responding to the FDA with words like “I followed exactly what you defined in your standard” or “your FDA standard said that this issue should be handled this way and we did it as defined”. How could the FDA respond to that? Also, for a body (FDA, etc.) to define "how to assure" may have a dramatic company cost impact which could be a whole new problem for a certification agency.

Instead, the FDA identifies what you need to "assure". How you assure is completely up to you and your company and then you will be measured by the FDA on if you met the intent of their words. Have you ever become involved in a discussion where their interpretation is different from theirs? Guess what, seeing that they wrote what you need to assure, they have the last word on what you need to do.

GDP can be defined by many companies in many ways. It’s not specifically one way, ”GDP” is defined/interpreted by the company person writing the internal P&P and hopfully it's in line with the auditing body (FDA or ISO certification house). Assurances can be accomplished in a number of ways, some easier than others some harder than others but they should all reach the same end goal.

Remember it's not the FDA, ISO cert house, or DoD responsibility to tell you how to do it but it is their responsibility to identify what you need to assure.

Thanks,

Linedraw
(Former DoD Auditor)