• A Brief History Of Parenteral Process Validation — How We Got Here

    Process validation has been at the center of attention of regulators and parenteral industry practitioners for years — more than 40 years to be exact. This article will look at how process validation evolved to become the primary means of ensuring consistent, high-quality production of parenterals.

  • Knowledge Management — Opportunities & Challenges For Legacy Drug Products

    This article will explore specific challenges of managing knowledge in a legacy manufacturing environment and propose viable, practical solutions that have been found to be effective. These solutions allow practitioners to increase product and process understanding as well as performance.

  • Identifying Difficult-To-Clean Surfaces In Manufacturing And Packaging Equipment

    This article describes a practical risk-based approach for assessing and identifying the surfaces, areas, or sites of manufacturing and packaging equipment that are cleaned upon completion of oral solid dosage manufacturing production.

  • Pharmaceutical Ultrapure Water Systems: Valuable Lessons Learned From Other Industries

    In August 2002, the U.S. Food and Drug Administration (FDA) embarked on an initiative entitled Pharmaceutical CGMPs for the 21st Century ― A Risk-Based Approach.1 This initiative particularly emphasized the FDA’s recommendations regarding use of technological advances in pharmaceutical manufacturing, as well as implementation of modern risk management and quality system tools and concepts. The FDA’s continuous striving towards the goals outlined in this initiative resulted in the issuance of a number of guidances that provide industry with better tools towards modernization. These include guidance documents on process analytical technology (PAT)2 and process validation3.


Igor Gorsky

Igor Gorsky has been a pharmaceutical industry professional for over 30 years. He held multiple positions with increasing responsibility at Alpharma, Wyeth, and Shire. He worked in production, quality assurance, technical services, and validation, including as associate director of global pharmaceutical technology at Shire. He is currently principal consultant at ValSource. He is leading the PDA Water Interest Group and a PDA Task Force for revision of PDA TR 29: Points to Consider for Cleaning Validation. In addition, he is a member of ASTM E55 and one of the authors of ASTM E3106 and E3207. He has a BS in mechanical/electrical engineering technology from Rochester Institute of Technology.