Good Documentation Practice - GDocP
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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