This article was co-authored by Senior Consultants Igor Gorsky and Darius Pillsbury, with additional contributors.

ValSource Business Unit Manager Kelly Waldron, PhD, was a lead author of the Quality Risk Management (QRM) Chapter in this publication.

Principles of Parenteral Solution Validation, A Practical Lifecycle Approach – edited by Igor Gorsky and Harold S. Baseman – is part of the Expertise in Pharmaceutical Process Technology series published by Academic Press (Elsevier) and edited by Michael Levin. This book is a comprehensive review of the sequence of activities leading to the current practice of sterile product validation, including example data and case studies.