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

[ChemistAnalytical]

I know I'm late to the conversation but I, too, had this question. Here is what I found:

The Rules Governing Medicinal Products in the European Union (Vol4 GMP) (Chapter 4 Documentation)​

https://ec.europa.eu/health//sites/health/files/files/eudralex/vol-4/chapter4_01-2011_en.pdf​

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WHO Annex 5 Guidance on good data and record management practices​

http ://apps.who .int/ medicinedocs /documents/s22402en/s22402en.pdf - IS NOW A DEAD LINK.​

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Data Integrity and Compliance With Drug CGMP Questions and Answers Guidance for Industry​

https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM495891.pdf​

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GOOD DOCUMENTATION GUIDELINES USP 1029​

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Good Manufacturing Practices Guidance Document (Annex 3)​

Good Manufacturing Practices Guidance Document - Canada.ca ​

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GOOD PRACTICES FOR DATA MANAGEMENT AND INTEGRITY IN REGULATED GMP/GDP ENVIRONMENTS ​

http s://www .gmp-publishing .com/ media/ files/ news_documents/PI_041_1_Draft_3_Guidance_on_Data_Integrity_1.pdf - LINK IS NOW A 404 DOCUMENT. LIVE LINK REMOVED. Found and attached.​

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There is also the GAMP, but that isn't free. I have also read "about" warning letters which are helpful (see good documentation practices at Wikipedia). However, FDA has made their warning letter search almost impossible.

 

[Marc]

@ChemistAnalytical - Good post. Thanks!

I have read through this old thread and deleted a number of dead links in posts, most of which were to FDA .pdf files.

As a caution/reminder, over the years links do go dead for a number of reasons. It is always a good idea when there is a .pdf link to download the .pdf file to your computer.

As to posters, FDA .pdf files are not copyright so you can download them and attach them to your post in a thread here if you like. But then again, Elsmar has been online for over 23 years, besides the 10 months that it was forced off line. One day Elsmar may also be gone. Twenty three years is a long time.

As an aside, when ever you are reading an old thread like this - If you find one or more Dead Links in a post, PLEASE - Report the post so that we can fix or delete the dead link(s).