Holdings: Technology Transfer :: Universität Regensburg

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Bibliographic Details
Title:	Technology Transfer Drug Product Manufacturing Process /
From:	by Ajay Babu Pazhayattil, Sanjay Sharma, Joe Paul Philip, Michelle Gischewski-Silva, Marzena Ingram.
Person:	Pazhayattil, Ajay Babu. author. aut http://id.loc.gov/vocabulary/relators/aut Sharma, Sanjay. Philip, Joe Paul. Gischewski-Silva, Michelle. Ingram, Marzena.
Main Authors:	Pazhayattil, Ajay Babu (Author), Sharma, Sanjay (Author), Philip, Joe Paul (Author), Gischewski-Silva, Michelle (Author), Ingram, Marzena (Author)
Corporate Author:	SpringerLink (Online service)
Format:	Electronic eBook
Language:	English
Published:	Cham : Springer International Publishing : Imprint: Springer, 2023.
Edition:	1st ed. 2023.
Series:	AAPS Introductions in the Pharmaceutical Sciences, 10
Subjects:	Pharmacy. Pharmaceutical chemistry. Pharmacology. Drug delivery systems. Pharmacovigilance. Pharmaceutics. Drug Delivery. Drug Safety and Pharmacovigilance.
Online Access:	https://doi.org/10.1007/978-3-031-32192-4
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 ofthe 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.
Physical Description:	1 Online-Ressource (XIV, 148 p. 78 illus., 55 illus. in color.)
ISBN:	9783031321924
ISSN:	2522-8358 ;

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author	Pazhayattil, Ajay Babu Sharma, Sanjay Philip, Joe Paul Gischewski-Silva, Michelle Ingram, Marzena
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contents	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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spelling	Pazhayattil, Ajay Babu. author. (orcid)0000-0002-9755-8806 https://orcid.org/0000-0002-9755-8806 aut http://id.loc.gov/vocabulary/relators/aut Technology Transfer [electronic resource] : Drug Product Manufacturing Process / by Ajay Babu Pazhayattil, Sanjay Sharma, Joe Paul Philip, Michelle Gischewski-Silva, Marzena Ingram. 1st ed. 2023. Cham : Springer International Publishing : Imprint: Springer, 2023. 1 Online-Ressource (XIV, 148 p. 78 illus., 55 illus. in color.) text txt rdacontent computer c rdamedia online resource cr rdacarrier text file PDF rda AAPS Introductions in the Pharmaceutical Sciences, 2522-8358 ; 10 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 ofthe 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. Pharmacy. Pharmaceutical chemistry. Pharmacology. Drug delivery systems. Pharmacovigilance. Pharmaceutics. Drug Delivery. Drug Safety and Pharmacovigilance. Sharma, Sanjay. author. aut http://id.loc.gov/vocabulary/relators/aut Philip, Joe Paul. author. aut http://id.loc.gov/vocabulary/relators/aut Gischewski-Silva, Michelle. author. aut http://id.loc.gov/vocabulary/relators/aut Ingram, Marzena. author. aut http://id.loc.gov/vocabulary/relators/aut SpringerLink (Online service) Springer Nature eBook Printed edition: 9783031321917 Printed edition: 9783031321931 Printed edition: 9783031322198
spellingShingle	Pazhayattil, Ajay Babu Sharma, Sanjay Philip, Joe Paul Gischewski-Silva, Michelle Ingram, Marzena Technology Transfer Drug Product Manufacturing Process / AAPS Introductions in the Pharmaceutical Sciences, 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. Pharmacy. Pharmaceutical chemistry. Pharmacology. Drug delivery systems. Pharmacovigilance. Pharmaceutics. Drug Delivery. Drug Safety and Pharmacovigilance.
title	Technology Transfer Drug Product Manufacturing Process /
title_auth	Technology Transfer Drug Product Manufacturing Process /
title_exact_search	Technology Transfer Drug Product Manufacturing Process /
title_full	Technology Transfer [electronic resource] : Drug Product Manufacturing Process / by Ajay Babu Pazhayattil, Sanjay Sharma, Joe Paul Philip, Michelle Gischewski-Silva, Marzena Ingram.
title_fullStr	Technology Transfer [electronic resource] : Drug Product Manufacturing Process / by Ajay Babu Pazhayattil, Sanjay Sharma, Joe Paul Philip, Michelle Gischewski-Silva, Marzena Ingram.
title_full_unstemmed	Technology Transfer [electronic resource] : Drug Product Manufacturing Process / by Ajay Babu Pazhayattil, Sanjay Sharma, Joe Paul Philip, Michelle Gischewski-Silva, Marzena Ingram.
title_short	Technology Transfer
title_sort	technology transfer drug product manufacturing process
title_sub	Drug Product Manufacturing Process /
topic	Pharmacy. Pharmaceutical chemistry. Pharmacology. Drug delivery systems. Pharmacovigilance. Pharmaceutics. Drug Delivery. Drug Safety and Pharmacovigilance.
topic_facet	Pharmacy. Pharmaceutical chemistry. Pharmacology. Drug delivery systems. Pharmacovigilance. Pharmaceutics. Drug Delivery. Drug Safety and Pharmacovigilance.
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