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Quality Control Analytical Methods: End-preparation Assessments and Tests for Compounded Sterile Preparations

Author(s):  McElhiney Linda F

Issue:  Jul/Aug 2013 - Volume 17, Number 4
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Abstract:  Outsourcing has become a necessity to obtain sterile products that are currently on backorder. Because of the expense of outsourcing sterile compounding, pharmacy leadership in health systems are now considering the option of insourcing and batch preparing compounded sterile preparations, which can be a viable option for a health system. It can significantly decrease drug-spending costs, and the pharmacy has a complete record of the compounding process. The key to preparing high-quality, safe, sterile preparations and meeting United States Pharmacopeia standards is end-preparation assessments and tests.

Related Keywords: Linda F. McElhiney, PharmD, RPh, FIACP, FASHP, FACA, compounded sterile preparations, drug costs, drug shortages, outsourcing, drug safety, United States Pharmacopeia compliance, USP, end-preparation assessment, contamination, batch preparation, sterility testing, endotoxin testing, pyrogen testing, potency testing, purity testing, particulate testing, pH testing, quality assurance

Related Categories: STERILE PREPARATIONS, QUALITY CONTROL, UNITED STATES PHARMACOPEIA CONVENTIONS

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