Recent Issues and Regulatory Requirements of Data Integrity in Pharmaceutical Industry

Abstract

Pharmaceutical manufacturers are responsible for providing safe and effective high-quality products to patients and consumers by assuring that decisions on production and distribution of products are based on accurate, reliable, truthful, and complete data. Nevertheless, in recent years, regulatory authorities have increasingly observed good manufacturing practice (GMP) violations related to data integrity during GMP inspections. This is problematic since ensuring data integrity is a mandatory requirement to assure the safety, efficacy, and quality of drug products. The breaches in data integrity found during inspections have set off the need to publish more detailed guidance documents that describe more clearly the regulatory expectations in GMP-related systems. With new awareness derived from recent regulatory restrictions, industry uses state-of-the-art technology to improve processes and establish systems for detection and mitigation of gaps that affect data integrity in paper and computerized systems. Recently issued guidances by regulatory agencies emphasize the importance of good laboratory and manufacturing documentation practices. The main purpose of regulatory requirements remains confident in the quality and integrity of the data generated to ensure patient safety and product quality. This review summarizes data integrity guidances and risk assessment that facilitate firms to develop robust data integrity management system with both manual processes with paper records and computerized systems.