ARTICLES BY IGOR GORSKY

• 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.

• 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.