BRIEFING
〈1029〉 Good Documentation Guidelines. This proposal is based on the version of the chapter official as of May 1, 2018. The General Chapters—Chemical Analysis Expert Committee is proposing the following revised chapter. On the basis of comments received from stakeholders, the name of this general chapter has been changed from “Good Documentation Guidelines” to “Good Documentation Guidelines and Data Integrity”. This revision is proposed to update the general chapter to include ALCOA++ (attributable, legible, contemporaneous, original, and accurate) concepts and definitions and to be compatible with the life cycle models described in general chapters Analytical Procedure Life Cycle 〈1220〉 and Analytical Instrument Qualification 〈1058〉. Data governance is not in the scope of this chapter and will be the subject of another general chapter in the future.
Additionally, minor editorial changes have been made to update the chapter to current USP style.
(GCCA: Y. Liu)
Correspondence Number—SUB-2082