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Good Documentation Practice - GDocP

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Guest user Created:   Nov 07, 2016 Last commented:   Nov 07, 2016

Good Documentation Practice - GDocP

Are you familiar with the "Good Document Practices"? I am trying to find more information about it. It seems to be closely related to ISO as they seem to emphasize the same principles of the importance of good documentation.
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ISO 9001 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

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Strahinja Stojanovic Nov 07, 2016

But I cannot find a direct link to them. Is this a completely separate thing from ISO? Does a separate body do the auditing and registration for this?

Answer:

Good documentation practice (commonly abbreviated GDP, recommended to abbreviate as GDocP to distinguish from "good distribution practice" also abbreviated GDP) is a term in the pharmaceutical industry to describe standards by which documents are created and maintained. GDocP has a lot of similar requirements as ISO 9001 but they have a lot of additional requirements and ISO 9001 would not be enough to cover GDocP.

GDocP is published by FDA (U.S. Food and Drug Administration) and WHO (World Health Organization) and it is not related to ISO, so other independent bodies are conducting the audit and they are called GMP regulators.

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Nov 07, 2016

Nov 07, 2016