Principles of Parenteral Solution Validation
  • Author : Igor Gorsky
  • Release Date : 15 April 2019
  • Publisher : Academic Press
  • Genre : Medical
  • Pages : 208
  • ISBN 13 : 9780128094129

Principles of Parenteral Solution Validation Book Summary

Principles of Parenteral Solution Validation: A Practical Lifecycle Approach covers all aspects involved in the development and process validation of a parenteral product. By using a lifecycle approach, this book discusses the latest technology, compliance developments, and regulatory considerations and trends, from process design, to divesting. As part of the Expertise in Pharmaceutical Process Technology series edited by Michael Levin, this book incorporates numerous case studies and real-world examples that address timely problems and offer solutions to the daily challenges facing practitioners in this area. Discusses international and domestic regulatory considerations in every section Features callout boxes that contain points-of-interest for each segment of the audience so readers can quickly find their interests and needs Contains important topics, including risk management, the preparation and execution of properly designed studies, scale-up and technology transfer activities, problem-solving, and more

Principles of Parenteral Solution Validation

Principles of Parenteral Solution Validation

Author : Igor Gorsky,Harold S. Baseman
Publisher : Academic Press
Genre : Medical
Total View : 3645 Views
File Size : 54,6 Mb
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Principles of Parenteral Solution Validation: A Practical Lifecycle Approach covers all aspects involved in the development and process validation of a parenteral product. By using a lifecycle approach, this book discusses the latest technology, compliance developments, and regulatory considerations and trends, from process design, to divesting. As part of the ...

Principles of Parenteral Solution Validation

Principles of Parenteral Solution Validation

Author : Igor Gorsky,Harold S. Baseman
Publisher : Academic Press
Genre : Medical
Total View : 8092 Views
File Size : 51,8 Mb
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Principles of Parenteral Solution Validation: A Practical Lifecycle Approach covers all aspects involved in the development and process validation of a parenteral product. By using a lifecycle approach, this book discusses the latest technology, compliance developments, and regulatory considerations and trends, from process design, to divesting. As part of the ...

Handbook of Validation in Pharmaceutical Processes  Fourth Edition

Handbook of Validation in Pharmaceutical Processes Fourth Edition

Author : James Agalloco,Phil DeSantis,Anthony Grilli,Anthony Pavell
Publisher : CRC Press
Genre : Medical
Total View : 8890 Views
File Size : 47,5 Mb
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Revised to reflect significant advances in pharmaceutical production and regulatory expectations, Handbook of Validation in Pharmaceutical Processes, Fourth Edition examines and blueprints every step of the validation process needed to remain compliant and competitive. This book blends the use of theoretical knowledge with recent technological advancements to achieve applied practical ...

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Author : Ira R. Berry,Robert A. Nash
Publisher : CRC Press
Genre : Medical
Total View : 4778 Views
File Size : 48,6 Mb
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Updated to reflect current good manufacturing practice (CGMP) regulations, this text discusses current concepts in validation. New topics covered include: validation of cleaning systems and computer systems; equipment and water systems validation; and lyophilized and aerosol product validation....

Parenteral Medications  Fourth Edition

Parenteral Medications Fourth Edition

Author : Sandeep Nema,John D. Ludwig
Publisher : CRC Press
Genre : Business & Economics
Total View : 3793 Views
File Size : 53,8 Mb
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Parenteral Medications is an authoritative, comprehensive reference work on the formulation and manufacturing of parenteral dosage forms, effectively balancing theoretical considerations with practical aspects of their development. Previously published as a three-volume set, all volumes have been combined into one comprehensive publication that addresses the plethora of changes in the ...

Sterile Product Development

Sterile Product Development

Author : Parag Kolhe,Mrinal Shah,Nitin Rathore
Publisher : Springer Science & Business Media
Genre : Medical
Total View : 3972 Views
File Size : 45,6 Mb
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This comprehensive book encompasses various facets of sterile product development. Key concepts relevant to the successful development of sterile products are illustrated through case studies and are covered under three sections in this book: • Formulation approaches that discuss a variety of dosage forms including protein therapeutics, lipid-based controlled delivery systems, ...