Principles of Parental Solution Validation - 1st Edition - ISBN: 9780128094129

Principles of Parental Solution Validation

1st Edition

A Practical Lifecycle Approach

Editors: Igor Gorsky
Paperback ISBN: 9780128094129
Imprint: Academic Press
Published Date: 1st November 2017
Page Count: 208
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Description

Principles of Parental Solution Validation: A Practical Lifecycle Approach covers all aspects of the activities required in the development and process validation of a parenteral product. By using a lifecycle approach, this book discusses the latest technology, compliance developments, regulatory considerations and recent 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 in order to address and offer solutions to the daily challenges facing practitioners in this area.

Key Features

  • Discusses international and domestic regulatory considerations in every section
  • Features 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 design studies, scale-up and technology transfer activities, problem-solving, and more

Readership

Pharmaceutical and associated industry professionals involved in process development and qualification of parenteral products, including R&D personnel involved in manufacturing, technology transfer and quality assurance, as well as process engineers and regulatory officials

Table of Contents

Introduction
Update of new developments, regulatory trends/citations
Stage 1 – Process Design
Stage 2 – Process Qualification
Stage 3 – Continued Process Verification
Conclusion

Details

No. of pages:
208
Language:
English
Copyright:
© Academic Press 2018
Published:
Imprint:
Academic Press
Paperback ISBN:
9780128094129

About the Editor

Igor Gorsky

Igor Gorsky is a Senior Consultant with ConcordiaValSource

Affiliations and Expertise

Senior Consultant, ConcordiaValSource