Good Documentation Practices (GDocP)
Good Documentation Practices (GDocP) is a concept that helps ensure veracity of the contents of documents and records.
USP has recently published draft guidelines for GDocP in the Pharmacoepial Forum that we would encourage you to read.
When conducting activities under GxP (where the ‘G’ stands for ‘Good’, ‘P’ stands for ‘Practices’, and the ‘x’ represents the range of practices in the regulated environment such as Manufacturing, Laboratory, Clinical, etc.) you need to follow GDocP to ensure acceptability of documents and records.
Controlled Documents
Controlled documents and records (hereafter just referred to as ‘documents’) are legal documents used in regulated environments to fulfil regulatory requirements.
Document dates must have an appropriate meaning and those signing the documents must be qualified for the content they are approving.
The integrity of controlled documents should never be under question. Control must be shown at all times so that the content can withstand legal scrutiny.
Control, in this context, is beyond storing a document in a binder in the document control room. We’ll explore what “control” really means throughout.