World Health Organization (WHO) drafted a new guideline on data integrity on 19th November 2019. This highlighted the importance of the reliability of data and information in the production and control of pharmaceuticals.
Due to the recent increase of observations in the integrity of data relating to,
- Documentation
- Record Management
- Good Manufacturing Practice (GMP)
- Good Clinical Practice (GCP)
- Good Laboratory Practice (GLP)
The 28-page guideline would assist and recommend companies to use a written data integrity policy. For data documented on paper, WHO warned against the use of pencil, erasers and correction fluid. Companies must ensure that paper records are archived properly by designated personnel in secured and controlled areas.
10 examples of good documentation practices in data integrity are also included in the guideline to offer companies a step by step guide.