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

被引：3
|
作者：
Pedro, Francisca [1 ]
Veiga, Francisco [1 ,2 ]
Mascarenhas-Melo, Filipa [1 ,2 ]
机构：
[1] Univ Coimbra, Fac Pharm, Drug Dev & Technol Lab, Coimbra, Portugal
[2] Univ Coimbra, Fac Pharm, REQUIMTE LAQV, Grp Pharmaceut Technol, Coimbra, Portugal
来源：
DRUG DISCOVERY TODAY | 2023年 / 28卷 / 11期
关键词：
Good Automated Manufacturing Practices; GAMP; 5; Data Integrity; QbD; Computerized System Validation; Pharmaceutical Industry; Drug; Quality Assurance; REGULATORY COMPLIANCE; DESIGN; MANAGEMENT; SYSTEMS; FUTURE;
D O I：
10.1016/j.drudis.2023.103759
中图分类号：
R9 [药学];
学科分类号：
1007 ;
摘要：
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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页数：9
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