Glossary
Good Documentation Practices (GDocP)
The collective term for the ways in which all records, paper or electronic, are prepared, reviewed, and controlled so that they meet the data integrity principles (ALCOA+).
Details
This treats data integrity not as a separate activity but as the everyday way documents are made and handled. PIC/S applies the same principles to paper and electronic records and requires procedures to cover the preparation, review, and approval of source documents and procedures, the generation, distribution, and control of record templates, and retrieval and disaster recovery. The corpus includes European and UK inspection reports where weakness in this practice led to data integrity and traceability problems, and cases where a finding repeated from a previous inspection was escalated to major. What is judged is not the single erroneous record but the document management system that allowed such errors to arise.
Related sections
Related terms
Real inspection findings
Findings from regulators' inspection documents in which this term appears.
-
Inadequate cross contamination measures, lack of good documentation practices leading to data integrity and traceability issues and inadequate packaging operations which were leading to mix ups were of critical concern.
EMA · EU GMP NCR (EudraGMDP) · 2024-07-02 -
The management of change control, deviations, risk assessments and good documentation practices within the organisation were also found to be severely lacking.
EMA · EU GMP NCR (EudraGMDP) · 2026-05-05 -
Your QU failed to ensure good documentation practices in your facility as evidenced by: • A Batch Manufacturing Production logbook was found with pages torn out • Numerous signed and partially completed batch records which lacked the…
FDA · FDA Warning Letter · 2022-02-15
