Good Documentation Practice (GDocP)
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A Good Documentation Practice (GDocP) is a best practice for document management.
- Example(s):
- Clinical Research GDocP, such as ALCOA (and ALCOA+).
- …
- Counter-Example(s):
- See: Guidelines, Drug Distribution, Document, Codification (Law), Competent Authority, Investigator Site Inspection, Sponsor Audit.
References
2021
- (Wikipedia, 2021) ⇒ https://en.wikipedia.org/wiki/Good_documentation_practice Retrieved:2021-11-18.
- 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 and medical device industries to describe standards by which documents are created and maintained. While some GDP / 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 GDP / 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.
- 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 and medical device industries to describe standards by which documents are created and maintained. While some GDP / 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 GDP / 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.
2021
- (Wikipedia, 2021) ⇒ https://en.wikipedia.org/wiki/Good_documentation_practice#Documentation_creation Retrieved:2021-11-19.
- Contemporaneous with the event they describe
- Not handwritten (except for handwritten entries thereon)
- When electronically produced, the documentation must be checked for accuracy
- Free from errors
- For some types of data, it is recommended that records are in a format that permits trend evaluation
- (Bargaje, 2011) ⇒ Chitra Bargaje. (2011). “Good Documentation Practice in Clinical Research.” In: Perspectives in Clinical Research, 2(2).
- ABSTRACT: One of the most common inspection findings in investigator site inspections is lack of reliable, accurate and adequate source documentation. This also happens to be the most common pitfall identified during sponsor audits. The importance of good documentation practice needs to be emphasized to investigator sites to ensure that the study results are built on the foundation of credible and valid data. This article focuses on the key principles of good documentation practice and offers suggestions for improvement.
Keywords: ALCOA, documentation, source, training