Sterile Processing of Pharmaceutical Products - Engineering Practice, Validation, and Compliance in Regulated Environments

药品的无菌加工:受监管环境中的工程实践、验证与合规性

化学工程基础学科

原   价:
1990
售   价:
1592.00
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作      者
出  版 社
出版时间
2022年01月04日
装      帧
精装
ISBN
9781119802327
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页      码
368
开      本
15.24 x 22.86 cm.
语      种
英文
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图书简介
This book explores methodologies and illustrates how applying scientific-based approach can achieve drug manufacturing goals and objectives, while upgrading the skill level of each company employee. Success is thereby determined by a clear understanding of current good manufacturing practice (cGMP), and with the focus on simplified - but flawless - performance. It highlights key ideas and factors to guide professionals in learning more about an important sector of pharmaceutical and biopharmaceutical manufacturing facilities, including operational requirements. This book covers various regulations and guidelines instituted by the FDA, ISPE, EMA, MHRA and ICH to emphasize good manufacturing practice (GMP) and preapproval inspection (PAI) requirements in the sterile manufacture of medicinal products.
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