ARTICLES BY IGOR GORSKY
A Brief History Of Parenteral Process Validation — How We Got Here6/29/2020
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 Products6/1/2020
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 Equipment4/15/2020
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.