In recent years, the number of observations made regarding data integrity, document management practices, and records management during Good Manufacturing Practice (GMP), Good Clinical Practice (GCP), and Good Laboratory Practice (LPG) inspections have been increasing. The possible causes include:
- reliance on inappropriate human practices;
- poorly defined procedures;
- resource limitations;
- use of computer systems unable to comply with regulatory requirements or that are improperly handled and validated;
- inappropriate data flow (eg manual data transfer); and
- failure to adequately review the original data and records.
To address these gaps, WHO has developed a new draft of Data Integrity (Working document QAS/19.819/Rev.1), a guide that consolidates all the regulatory principles. The new guide seeks to help identify insufficient or false data, improve product quality in global markets, and ultimately improve health outcomes.
The guide is intended to be presented at the 55th planned congress of the ECSPP (Expert Committee on Specifications for Pharmaceutical Preparations) in October 2020.