Impact of GAMP 5, data integrity and QbD on quality assurance in the pharmaceutical industry: How obvious is it?

Abstract

In the pharmaceutical industry, it is essential to ensure the safety and efficacy of medicinal products. Therefore a robust quality assurance framework is needed. This manuscript examines the impact of GAMP 5 and data integrity (DI) on quality assurance, while also highlighting the role of quality by design (QbD) principles. GAMP 5 is a widely used framework for validating automated systems that establishes quality assurance practices. DI guarantees the reliability of data collected throughout various stages of drug development. The integration of QbD principles promotes a systematic approach to development that emphasizes a deep understanding of critical quality attributes, risk management, and continuous improvement. With their implementation, organizations are able to meet regulatory requirements and provide safe medications to patients worldwide.

Keywords: Computerized System Validation; Data Integrity; Drug; GAMP 5; Good Automated Manufacturing Practices; Pharmaceutical Industry; QbD; Quality Assurance.