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Technology transferdrug product manufacturing process /

紀錄類型:	書目-電子資源 : Monograph/item
正題名/作者:	Technology transferby Ajay Babu Pazhayattil ... [et al.].
其他題名:	drug product manufacturing process /
其他作者:	Pazhayattil, Ajay Babu.
出版者:	Cham :Springer International Publishing :2023.
面頁冊數:	xiv, 148 p. :ill. (some col.), digital ;24 cm.
Contained By:	Springer Nature eBook
標題:	Pharmaceutical technology.
電子資源:	https://doi.org/10.1007/978-3-031-32192-4
ISBN:	9783031321924$q(electronic bk.)

Technology transferdrug product manufacturing process /
Technology transferdrug product manufacturing process /[electronic resource] :by Ajay Babu Pazhayattil ... [et al.]. - Cham :Springer International Publishing :2023. - xiv, 148 p. :ill. (some col.), digital ;24 cm. - AAPS introductions in the pharmaceutical sciences,102522-8358 ;. - AAPS introductions in the pharmaceutical sciences ;v. 9..

Chapter 1: Current Status of Technology Transfer -- Chapter 2: Quality by Design (QbD) Process Design -- Chapter 3: Quality Risk Management (QRM) -- Chapter 4: Technology Transfer Process -- Chapter 5: Scaling-Up of Solid Orals: Granulation, Drying, Size Reduction, Blending, Compression, and Coating Technologies -- Chapter 6: Qualification, Continued Process Verification, and Lifecycle Management -- Chapter 7: Continuous Improvement Case Study: Transforming Legacy Products.

Currently, there are no textbooks on drug product manufacturing technology transfer that incorporate the latest regulatory expectations. Recent guidance from regulatory bodies such as the US FDA, EMEA, WHO, and PIC/S has adopted the ICH Lifecycle approach harmonizing concepts across regulatory guidance. This allows organizations to align their technology transfer activities for all regulated markets. However, there is a need for consensus and direction in approaching technology transfer, particularly in understanding how to manage the scale-up effects to ensure regulatory compliance. This textbook offers technology transfer solutions and guidance to the pharmaceutical industry. The chapters provide a systematic understanding of applying the technology transfer concepts in pharmaceutical manufacturing, promoting standardization within the industry. Since Stage 1b is not specified in detail within the regulations, pharmaceutical organizations are left to determine the requirements of the stage. The need to justify the methodologies and utilization of sound science makes it more demanding. The textbook's authors provide innovative solutions for technology transfer challenges, making it a comprehensive reference document. The approaches can be applied to both small-molecule and large-molecule drug product manufacturing segments, addressing the unmet needs of the industry.

ISBN: 9783031321924$q(electronic bk.)

Standard No.: 10.1007/978-3-031-32192-4doiSubjects--Topical Terms:

237657
Pharmaceutical technology.

LC Class. No.: RS192

Dewey Class. No.: 615.19

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