Basics of Pharmaceutical Manufacturing and Quality Operations

药品生产与质量操作基础:综合指南

工业经济学

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1182.00
发货周期:国外库房发货,通常付款后3-5周到货!
出  版 社
出版时间
2024年03月14日
装      帧
精装
ISBN
9781032432052
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页      码
254
开      本
234 x 156 mm (6.14 x 9.21
语      种
英文
版      次
1
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图书简介
This book provides guidance on how to meet the requirements of the pharmaceutical industry as a beginner. It includes procedures for production and packaging, batch auditing as well as all quality measures used in the pharmaceutical industry. This book also provides questions and answers with each chapter for institutes and trainers providing basic training to the new graduates and new comers to the industry.Basics of Pharmaceutical Manufacturing and Quality Operations: A Comprehensive Guide is primarily written for anyone in the pharmaceutical industry interested in development and manufacturing of active pharmaceutical ingredient (API) and finished pharmaceutical manufacturers in both sterile and non-sterile areas. The book is a simple, concise, and easy to use reference tool covering basic quality concepts required by the pharmaceutical educational institutions and professional certification bodies. It describes details of all GXP activities that are directly related to Quality, Safety, and Efficacy of the products manufactured under the umbrella of Quality Operations, common testing methods which are used in any modern industry, Requirements of Validation and Qualification of equipment, facilities and processes, integral segments of Drug product manufacturing, storage, and distribution practices. The material provides stepwise guidance on how to evaluate, audit, qualify, and approve a pharmaceutical product to enhance the GMP within the industry.The book is written with the idea of providing basic knowledge to undergraduate students who are preparing to enter the industry at the end of their graduation. The book would also be beneficial for institutions conducting pharmaceutical technology study courses in terms of GMP and GLP applications.Features:Provides readers and front line health care product manufacturers, all the information they need to know to develop a GMP oriented industry with trained and skilled
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