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14 Pharmaceutical Technology ® Quality and Regulatory Sourcebook eBook March 2024 PharmTech.com Sukjai Photo - Stock.adobe.com T his article is a sequel of the an article pub- lished in the Parenteral Drug Association's Journal of Pharmaceutical Science and Technol- ogy (1) and provides industry with additional options and thoughts on meeting quality risk manage- ment (QRM) needs for the manufacture of sterile and microbiologically sensitive products. Part 1 of this ar- ticle resulted in considerable industry response with respect to its utilization and increasing opportunities to address current technology needs and regulato- ry challenges. This response includes the use and refinement of the method for new applications. In this second article, the authors discuss and present more application scenarios where the Intervention Risk Evaluation Method (IREM) can be used for ef- fectively assessing and mitigating risks of human interventions and improving the overall sterility as- surance level of the final products, further refining and aligning the method with industry needs and regulatory expectations. Although performing effective risk assessments has long been considered as beneficial for the design, per- formance, and evaluation of aseptic processes, as well as a strong regulatory expectation, it continues to be an area of concern and a challenge for pharmaceuti- cal companies. With the advent of advanced therapy medicinal products (ATMPs), complex aseptic formu- lations, and modern manufacturing technologies, ob- Intervention Risk Evaluation and Management in Aseptic Manufacturing–Part II Subrata Chakraborty is founder and CEO at GxPFONT Consulting, INOVR, subrata.chakraborty@inophar.in. Hal Baseman is COO at ValSource. Michael A. Long is senior director at AstraZeneca. IREM can be used for effectively assessing and mitigating risks and improving the overall sterility assurance level in all types of aseptic processing lines.