GMP, GCP and GDP Data Governance and Data Integrity

Abstract

: Integration of data governance and data integrity within GMP, GCP, and GDP regulatory processes is a fundamental requirement for ensuring quality of products, patient safety, and regulatory compliance. GMP is a component of quality assurance which ensures the consistent production and control of products in compliance with required quality standards and marketing authorization specifications, thus establishing minimum requirements aimed at preventing risks to the consumer. Poor documentation practice often is a common issue for clinical research studies; therefore, reliable, accurate, and adequate source documentation is imperative for guaranteeing that the findings of research are based on credible and legitimate data sources.  Data integrity implies the accuracy, completeness, and consistency of data during its whole lifecycle which should be preserved in the original or in true copies, as well as adherence to ALCOA principles (attributable, legible, contemporaneous, original, and accurate). Metadata is an important element providing necessary context information about data. In GDP settings, data integrity can be ensured by proper handling and distribution. The approach to ensuring data integrity based on identification of associated risks such as data manipulation, loss, and corruption can be implemented with appropriate corrective measures using quality systems. Continuous monitoring of data systems, implementation of sound governance. In summary, proper governance of the data system, document management, and risk management help create an accurate, reliable, and compliant data system. If the integrity of the data is challenged, it could result in regulatory action, recalling of product, patient harm, and loss of trust among other serious consequences, highlighting the importance of data governance within the pharma industry.