Journal
DRUG DISCOVERY TODAY
Volume 28, Issue 11, Pages -Publisher
ELSEVIER SCI LTD
DOI: 10.1016/j.drudis.2023.103759
Keywords
Good Automated Manufacturing Practices; GAMP 5; Data Integrity; QbD; Computerized System Validation; Pharmaceutical Industry; Drug; Quality Assurance
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This manuscript examines the importance of a robust quality assurance framework in the pharmaceutical industry to ensure the safety and efficacy of medicinal products. It also discusses the impact of GAMP 5 and data integrity on quality assurance, and highlights the role of quality by design principles. The implementation of these principles enables organizations to meet regulatory requirements and provide safe medications to patients worldwide.
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.
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