ARTICLES BY IGOR GORSKY
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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.
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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.
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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.