Quality by design (QbD) for pharmaceutical area

B. Aksu, B. Mesut
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引用次数: 10

Abstract

Abstract: Recent changes and limited resources for drug development and manufacturing have rendered the conventional pharmaceutical quality assurance approach insufficient and have given rise to new research in these areas. To address these research efforts, the FDA improved and modernized the rules governing pharmaceutical manufacturing and product quality in 2002, thereby realizing a paradigm change in the current Good Manufacturing Practices (cGMP). The Quality by Design (QbD) approach has entered the pharmaceutical industry within the last 10 years after the approval of the ICH Q8 in 2005. QbD is based on an understanding of the target product’s quality profile (QTPP) and an assessment of its risks during the design and development of pharmaceutical dosage forms. By determining the critical quality attributes of the drug, including its active ingredient, its excipients, and the processes and design spaces used during the R&D phase, multi-way tracking during the life cycle of the drug can be achieved. This tracking can provide numerous advantages, including flexibility in licensing by decreasing the variation and type modifications in applications of the pharmaceutical product, which result from minimizing the possible issues arising after the release of the product. When all these data are observed, it is clear that the new QbD approach benefits the authorities, the drug manufacturers and the patient. Although QbD has certain challenges during its early stages, it is thought that QbD will benefit pharmaceutical manufacturers. Keywords: Quality by design (QbD), target product quality profile, critical quality attributes, design space, risk assessment.
医药领域的设计质量(QbD)
摘要:近年来药物开发和生产的变化和有限的资源使得传统的药物质量保证方法不足,并引发了这些领域的新研究。为了解决这些研究工作,FDA在2002年改进和现代化了药品生产和产品质量管理规则,从而实现了当前良好生产规范(cGMP)的范式变化。设计质量(QbD)方法在2005年ICH Q8批准后的10年内进入制药行业。QbD是基于对目标产品质量概况(QTPP)的理解,以及在药物剂型设计和开发过程中对其风险的评估。通过确定药物的关键质量属性,包括其活性成分,赋形剂,以及研发阶段使用的工艺和设计空间,可以实现药物生命周期内的多路跟踪。这种跟踪可以提供许多优点,包括通过减少药品申请中的变化和类型修改来灵活地许可,这是由于最小化了产品发布后可能出现的问题。当观察到所有这些数据时,很明显,新的QbD方法使当局、药品制造商和患者受益。尽管QbD在早期阶段存在一定的挑战,但人们认为QbD将使制药企业受益。关键词:设计质量(QbD),目标产品质量概况,关键质量属性,设计空间,风险评估
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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