USP: Chapter <1029> Good Documentation Guidelines and Data Integrity published for comment

The chapter "<1029> Good Documentation Guidelines and Data Integrity" has been published for comment on the website of the USP Pharmacopeial Forum since the beginning of July 2025. Comments and remarks on this draft, which is based on the previous version "<1029> Good Documentation Guidelines" from May 2018, can be submitted until September 30, 2025.

In addition to the new title, the draft now contains definitions and principles of ALCOA (including ALCOA+, ALCOA++). Along with formal changes, the information in this chapter has been aligned with the life cycle models of the chapters “Analytical Procedure Life Cycle” and “Analytical Instrument Qualification”.

The current draft consists of the following points:

• Introduction
  o Purpose
  o Scope
• Good Documentation Practice, Data Integrity, and Data Governance
  o Good Documentation Practice(s)
  o Data Integrity
• Best Practice Principles for Good Documentation
• Criteria for Data Integrity and Security of Records based on ALCOA++ PRINCIPLES
  o ALCOA
  o ALCOA+
  o ALCOA++
  o Data Collection and Recording
  o Retention of Documents
• Different Types of GMP Documents
  o Standard Operating Procedures
  o Protocols and Reports
  o Analytical Procedures
  o Training Documentation
  o Laboratory Records
  o Equipment, Instruments, and Systems Documentation
  o Deviations and Investigations
  o Batch Records
  o Certificate of Analysis

After a one-time registration, you can view and comment on the draft of the chapter "Good Documentation Guidelines and Data Integrity" on the Pharmacopeial Forum website.