What is it about?
This article summarizes and contrasts the regulations governing the compounding of sterile products and the manufacturing of commercial sterile products.
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Why is it important?
Many assume that compounded sterile products are governed by the same regulations as commercial sterile products and are therefore just as safe.
Perspectives
Having manufactured clinical supplies in the past, I was astounded to learn that some sterile compounding facilities manufacture their biosafety cabinets out of plywood. The industry standard is cleanable stainless steel. Writing this article really opened my eyes to the world of sterile compounding.
Dr Michelle L Wilson
Virtual Regulatory Solutions
Read the Original
This page is a summary of: Sterile Compounding Pharmacies, Therapeutic Innovation & Regulatory Science, March 2016, SAGE Publications,
DOI: 10.1177/2168479016636417.
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