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Quality Assurance for Sterile Products

Author(s):  Kastango Eric S, Douglass Kate

Issue:  Jul/Aug 2001 - Sterile Product Compounding
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Abstract:  The focus on developing, implementing and using quality systems during pharmacy preparation of sterile products has never been important than it is today. United States Pharmacopeia (USP) Chapter <1206> (“Sterile Drug Products for Home Use”) can be used as the standard for compounding sterile preparations. The focus of this article is to emphasize that the operating standards described in the American Society of Health-System Pharmacists Guidelines on Quality Assurance for Pharmacy-Prepared Products and/or USP Chapter <1206> should be reviewed and followed by responsible pharmacy personnel who prepare sterile products and to identify operating metrics that can be used to design a quality system for the preparation of sterile products in a pharmacy. The authors discuss process simulation testing, development of a dynamic environmental monitoring program, routine cleaning and sanitizing procedures, validation of aseptic technique, validation of compounding equipment and end-product testing. Figures provide information about types of activities validated by process simulation testing, pharmacy cleanroom environmental sampling locations and sample environmental monitoring scheduling. Tables cover baseline alert and action-limit values for pharmacy cleanroom environmental sampling, characteristics of cleaning and sanitizing agents and a sample cleaning plan for controlled work areas. A sample validation plan is also provided.

Related Keywords: Aseptic technique, validation of, End-product testing, sterile products, Equipment, compounding, validation of, Quality assurance, sterile products, Sterile products, quality assurance


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