Good documentation practice (recommended to abbreviate as GDocP to distinguish from "good distribution practice" also abbreviated GDP) is a term in the pharmaceutical and medical device industries to describe standards by which documents are created and maintained. While some GDocP standards are codified by various competent authorities, others are not but are considered cGMP (with emphasis on the "c", or "current"). Some competent authorities release or adopt guidelines, and they may include non-codified GDocP expectations. While not law, authorities will inspect against these guidelines and cGMP expectations in addition to the legal requirements and make comments or observations if departures are seen. In the past years, the application of GDocP is also expanding to cosmetic industry, excipient and ingredient manufacturers.
From the regulatory guidance above, additional expectations or allowances can be inferred by extension. Among these are:
The competent authorities are empowered to inspect establishments to enforce the law and the interpretations of the law (e.g., the content of guidance documents and the cGMPs).
Departures from GDocP that involved the regulator have included: documentation not contemporaneous,[11][12] use of ditto marks,[13] signature stamps.,[14][15] obscured original data,[16] Use of pencil,[16] inaccurate records,[16] and not dating changes.[17]
This article incorporates public domain material from "Guidance for Industry - COMPUTERIZED SYSTEMS USED IN CLINICAL TRIALS". U.S. Food and Drug Administration. April 1999. Archived from the original on 24 September 2020. Retrieved 15 October 2022.
