Solid Oral Dose Process Validation Volume Two
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Solid Oral Dose Process Validation Volume Two
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Author : Ajay Pazhayattil
language : en
Publisher: Springer Nature
Release Date : 2019-08-30
Solid Oral Dose Process Validation Volume Two written by Ajay Pazhayattil and has been published by Springer Nature this book supported file pdf, txt, epub, kindle and other format this book has been release on 2019-08-30 with Medical categories.
The textbook addresses the lifecycle concepts (Stage 1, 2, 3) of Process Validation. Regulatory bodies such as US FDA, EMEA, WHO, PIC/S have adopted the ICH lifecycle approach. Organizations have an opportunity to harmonize and align PV activities for all regulated markets. The concepts discussed provides a direction on how to approach solid dose manufacturing process validation for regulatory compliance. Solid Oral Dose Process Validation, Lifecycle Approach: Application, Volume Two and the companion Volume One, Solid Dose Process Validation, The Basics, also available as a set, provide directions and solutions for the pharmaceutical industry. The topics and chapters give a systematic understanding for the application of lifecycle concepts in solid dose pharmaceutical manufacturing. Since solid dose formulations encompass majority of the pharmaceutical preparations, it is essential information for pharmaceutical professionals who use the process validation lifecycle approach. This set is published as a comprehensive solution for solid dose process validation.
Solid Oral Dose Process Validation
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Author : Ajay Babu Pazhayattil
language : en
Publisher: Springer
Release Date : 2018-11-16
Solid Oral Dose Process Validation written by Ajay Babu Pazhayattil and has been published by Springer this book supported file pdf, txt, epub, kindle and other format this book has been release on 2018-11-16 with Medical categories.
Currently there are no process validation (PV) textbooks addressing the lifecycle concepts (Stage 1, 2, 3). Recent regulatory guidance's such as US FDA, EMEA, WHO, PIC/S have adopted the ICH lifecycle approach. The concepts are now harmonized across regulatory guidance's and organizations have an opportunity to align PV activities for all regulated markets. Therefore a need exists for consensus and direction on how to approach solid dose manufacturing process validation for regulatory compliance. Solid Dose Process Validation: The Basics, Volume One and companion Solid Dose Process Validation: Lifecycle Approach Application, Volume Two, also available as a set, provide directions and solutions for these unmet needs for the pharmaceutical industry. The topics and chapters give a systematic understanding for the application of lifecycle concepts in solid dose pharmaceutical manufacturing. All approaches meet the regulatory requirements enlisted in the guidance’s, which is the precursor to applying the concepts. This set is published as a comprehensive solution for solid dose process validation. Since solid dose formulations encompass majority of the pharmaceutical preparations, it is essential information for pharmaceutical professionals who use the process validation lifecycle approach.
Pharmaceutical Process Validation
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Author : Bernard T. Loftus
language : en
Publisher: Marcel Dekker
Release Date : 1984
Pharmaceutical Process Validation written by Bernard T. Loftus and has been published by Marcel Dekker this book supported file pdf, txt, epub, kindle and other format this book has been release on 1984 with Business & Economics categories.
Pharmaceutical Process Validation Second Edition
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Author : Ira R. Berry
language : en
Publisher: CRC Press
Release Date : 1993-01-29
Pharmaceutical Process Validation Second Edition written by Ira R. Berry and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 1993-01-29 with Medical categories.
The second edition of this text has been updated and enlarged to reflect current good manufacturing practice (CGMP) regulations and the increased interest in, and applicability of, process validation. "Pharmaceutical Process Validation" offers up-to-the-minute coverage of: regulations and validation; sterile process validation; organization in validation processes; solid dosage forms validation; raw material validation; analytical methods validation; and prospective and retrospective validation. Providing the contributions of leading experts in the field, the text also supplies examinations of current concepts in validation and new topics, such as: validation of cleaning systems and computer systems; equipment and water systems validation; and lyophilized and aerosol product validation.
Developing Solid Oral Dosage Forms
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Author : Yihong Qiu
language : en
Publisher: Academic Press
Release Date : 2009-03-10
Developing Solid Oral Dosage Forms written by Yihong Qiu and has been published by Academic Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2009-03-10 with Medical categories.
Developing Solid Oral Dosage Forms is intended for pharmaceutical professionals engaged in research and development of oral dosage forms. It covers essential principles of physical pharmacy, biopharmaceutics and industrial pharmacy as well as various aspects of state-of-the-art techniques and approaches in pharmaceutical sciences and technologies along with examples and/or case studies in product development. The objective of this book is to offer updated (or current) knowledge and skills required for rational oral product design and development. The specific goals are to provide readers with: Basics of modern theories of physical pharmacy, biopharmaceutics and industrial pharmacy and their applications throughout the entire process of research and development of oral dosage forms Tools and approaches of preformulation investigation, formulation/process design, characterization and scale-up in pharmaceutical sciences and technologies New developments, challenges, trends, opportunities, intellectual property issues and regulations in solid product development The first book (ever) that provides comprehensive and in-depth coverage of what's required for developing high quality pharmaceutical products to meet international standards It covers a broad scope of topics that encompass the entire spectrum of solid dosage form development for the global market, including the most updated science and technologies, practice, applications, regulation, intellectual property protection and new development trends with case studies in every chapter A strong team of more than 50 well-established authors/co-authors of diverse background, knowledge, skills and experience from industry, academia and regulatory agencies
How To Develop Robust Solid Oral Dosage Forms
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Author : Bhavishya Mittal
language : en
Publisher: Academic Press
Release Date : 2016-10-05
How To Develop Robust Solid Oral Dosage Forms written by Bhavishya Mittal and has been published by Academic Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2016-10-05 with Medical categories.
How to Develop Robust Solid Oral Dosage Forms from Conception to Post-Approval uses a practical and hands-on approach to cover the development process of solid oral dosage forms in one single source. The book details all of the necessary steps from formulation through the post-approval phase and contains industry case studies, real world advice, and troubleshooting tips. By merging the latest scientific information with practical instructions, this book provides pharmaceutical scientists in formulation research and development with a concrete look at the key aspects in the development of solid oral dosage forms. Focuses on important topics, such as robustness, bioavailability, formulation design, continuous processing, stability tests, modified release dosage forms, international guidelines, process scale-up, and much more Part of the Expertise in Pharmaceutical Process Technology series edited by Michael Levin Discusses common, real-world problems and offers both theoretical and practical solutions to these everyday issues
Process Validation In Manufacturing Of Biopharmaceuticals Third Edition
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Author : Anurag S. Rathore
language : en
Publisher: CRC Press
Release Date : 2012-05-09
Process Validation In Manufacturing Of Biopharmaceuticals Third Edition written by Anurag S. Rathore and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2012-05-09 with Medical categories.
Process Validation in Manufacturing of Biopharmaceuticals, Third Edition delves into the key aspects and current practices of process validation. It includes discussion on the final version of the FDA 2011 Guidance for Industry on Process Validation Principles and Practices, commonly referred to as the Process Validation Guidance or PVG, issued in final form on January 24, 2011. The book also provides guidelines and current practices, as well as industrial case studies illustrating the different approaches that can be taken for successful validation of biopharmaceutical processes. Case studies include Process validation for membrane chromatography Leveraging multivariate analysis tools to qualify scale-down models A matrix approach for process validation of a multivalent bacterial vaccine Purification validation for a therapeutic monoclonal antibody expressed and secreted by Chinese Hamster Ovary (CHO) cells Viral clearance validation studies for a product produced in a human cell line A much-needed resource, this book presents process characterization techniques for scaling down unit operations in biopharmaceutical manufacturing, including chromatography, chemical modification reactions, ultrafiltration, and microfiltration. It also provides practical methods to test raw materials and in-process samples. Stressing the importance of taking a risk-based approach towards computerized system compliance, this book will help you and your team ascertain process validation is carried out and exceeds expectations.
Ispe Baseline Guide
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Author : Ispe
language : en
Publisher:
Release Date : 2016-11-29
Ispe Baseline Guide written by Ispe and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2016-11-29 with categories.
Ispe Baseline Guide Volume 2 Oral Solid Dosage Forms
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Author : Ispe
language : en
Publisher:
Release Date : 2011-10-25
Ispe Baseline Guide Volume 2 Oral Solid Dosage Forms written by Ispe and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2011-10-25 with categories.
Validation Of Biopharmaceutical Manufacturing Processes
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Author : Brian D. Kelley
language : en
Publisher: Oxford University Press, USA
Release Date : 1998
Validation Of Biopharmaceutical Manufacturing Processes written by Brian D. Kelley and has been published by Oxford University Press, USA this book supported file pdf, txt, epub, kindle and other format this book has been release on 1998 with Medical categories.
The first complete one-volume reference on the topic, this book describes all aspects of process validation in the licensure of recombinant biologics, for both protein and non-protein products. It covers product synthesis, purification, and filling/finishing.