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Quality Control Analytical Methods: Laboratory Considerations of United States Pharmacopeia Chapter <71> Sterile Tests and Its Application to Pharmaceutical Compounding

Author(s):  Hyde Tiffany D

Issue:  Jan/Feb 2014 - Volume 18, Number 1
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Abstract:  The purpose of this article is to describe United States Pharmacopeia Chapter <71> Sterility Tests from the perspective of Current Good Manufacturing Practices in order to aid compounding pharmacists in understanding the details and complexities that are required. Compounding pharmacists face a unique challenge in the industry today, with their compounding practice and the U.S. Food and Drug Administration trying to impose Current Good Manufacturing Practices guidelines. Naturally, this becomes a challenge to contract testing laboratories as well, as they are caught between the testing for non-Current Good Manufacturing Practices compounding standards and Current Good Manufacturing Practices manufacturing. It is important that the compounding pharmacist and their partner testing laboratory work closely together to ensure appropriate requirements are being met.

Related Keywords: Tiffany D. Hyde, BS, United States Pharmacopeia, USP, sterility testing, Good Manufacturing Practices, compounded sterile preparations, U.S. Food and Drug Administration, FDA

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

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