제약산업에서의 데이터 완전성(Data Integrity) 관련 최근 이슈 및 규제 동향

초록

Pharmaceutical manufacturers are responsible for providing safe and effective high-quality products to patientsand 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 goodmanufacturing practice (GMP) violations related to data integrity during GMP inspections. This is problematic sinceensuring data integrity is a mandatory requirement to assure the safety, efficacy, and quality of drug products. The breachesin data integrity found during inspections have set off the need to publish more detailed guidance documents that describemore clearly the regulatory expectations in GMP-related systems. With new awareness derived from recent regulatoryrestrictions, industry uses state-of-the-art technology to improve processes and establish systems for detection andmitigation of gaps that affect data integrity in paper and computerized systems. Recently issued guidances by regulatoryagencies emphasize the importance of good laboratory and manufacturing documentation practices. The main purpose ofregulatory requirements remains confident in the quality and integrity of the data generated to ensure patient safety andproduct quality. This review summarizes data integrity guidances and risk assessment that facilitate firms to develop robustdata integrity management system with both manual processes with paper records and computerized systems.

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