Good Documentation Practice (GDP)
Good documentation practices are also known as GDocP. Alternatively, the abbreviation GRK (Good Record-Keeping) can be used for documentation studies.
This GDocP term is comprised of World Health Organization’s (WHO’s) Guidance on good data and record management practices. Organizations should follow good documentation practices (GDocP) in order to assure the accuracy, completeness, consistency, and reliability of the records and data throughout their entire period of use along with the data life cycle. The guidelines mandate that documentation should have the characteristics of being attributable, legible, contemporaneously recorded, original, and accurate (sometimes referred to as ALCOA).
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Attributable means information is captured in the record so that it is uniquely identified as having been executed by the originator of the data (e.g. a person or computer system).
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Legible, traceable, and permanent refer to the requirements that data are readable, understandable and allow a clear picture of the sequencing of steps or events in the record so that all GXP activities conducted can be fully reconstructed by people reviewing these records at any point during the records retention period set by the applicable GXP.
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Contemporaneous data are data recorded at the time they are generated or observed.
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Original data include the first or source capture of data or information and all subsequent data required to fully reconstruct the conduct of the GXP activity.
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Accurate means data are correct, truthful, complete, valid, and reliable.
PIC/S Guide to Good Manufacturing Practice for Medicinal Products - Part 1 defines the Good documentation practices as follows.
- If there are handwritten entries, they should be made in a clear, legible, indelible way.
- Records should be made or completed when the action is taken and in such a way that all significant activities associated with the manufacture of medicinal products are traceable.
- If an alteration is needed to the entry on a document, it should be signed and dated; the alteration should allow reading the original information. Where appropriate, the reason for the alteration should be recorded.
