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Summary of Quality-Control Testing for Sterile and Nonsterile Compounded Preparations, Part 2: Microbiological
1International Journal of Pharmaceutical Compounding. lallen@ijpc.com.
International Journal of Pharmaceutical Compounding
|July 18, 2019
Abstract:
This 2-part series discusses quality-control and quality-assurance issues along with physical and chemical analytical methods and microbiological testing related to both sterile and nonsterile compounded preparations. This second part covers microbiological testing, including sterility, bacterial endotoxins, preservative effectiveness, and microbial limit testing, along with continuous quality improvement, sample selection and requirements, out-of-specification results, and cost factors associated with testing.
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