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Technology transfer : drug product manufacturing process / Ajay Babu Pazhayattil, Sanjay Sharma, Joe Paul Philip, Michelle Gischewski-Silva, Marzena Ingram.

Pazhayattil, Ajay Babu, author.; Sharma, Sanjay, author.; Philip, Joe Paul, author.; Gischewski-Silva, Michelle, author.; Ingram, Marzena, author.
2023
RS192
Available Online
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Title
Technology transfer : drug product manufacturing process / Ajay Babu Pazhayattil, Sanjay Sharma, Joe Paul Philip, Michelle Gischewski-Silva, Marzena Ingram.
Author
Pazhayattil, Ajay Babu, author.
ISBN
9783031321924 (electronic bk.)
3031321928 (electronic bk.)
9783031321917
303132191X
DOI
https://doi.org/10.1007/978-3-031-32192-4
Published
Cham : Springer, [2023]
Copyright
©2023
Language
English
Description
1 online resource (xiv, 148 pages) : illustrations (some color).
Item Number
10.1007/978-3-031-32192-4 doi
Call Number
RS192
Dewey Decimal Classification
615.1/9
Summary
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 textbooks 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.
Bibliography, etc. Note
Includes bibliographical references and index.
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Access limited to authorized users.
Source of Description
Description based on print version record.
Added Author
Sharma, Sanjay, author.
Philip, Joe Paul, author.
Gischewski-Silva, Michelle, author.
Ingram, Marzena, author.
Series
AAPS introductions in the pharmaceutical sciences ; 10.
Available in Other Form
Technology transfer.
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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.

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