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Quality Control: Microbial Limit Tests for Nonsterile Pharmaceuticals, Part 2

Author(s):  Vu Nicole,Lou Jessica R,Kupiec Thomas C

Issue:  Jul/Aug 2014 - Volume 18, Number 4
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Abstract:  Cases of contaminated nonsterile products have been reported in increasing numbers. Often, these contaminated products are associated with the presence of objectionable microorganisms. The major contaminants of nonsterile pharmaceutical products and ingredients are bacteria, yeasts, and molds. The combination of parts 1 and 2 of this series of articles provides a thorough examination of microbiological quality testing for nonsterile products.

Related Keywords: Nicole Vu, PhD, Jessica R. Lou, BS, Thomas C. Kupiec, PhD, nonsterile compounding, microbial limit testing, contaminants, contamination, United States Pharmacopeia Chapter <61> Microbial Examination of Non-Sterile Products, United States Pharmacopeia Chapter <62> Tests for Specified Microorganisms, USP, bacteria, yeast, molds, fungi, microbiological acceptance criteria, dosage forms, specified micro-organisms, testing media, testing medium, test frequency, stability testing, objectionable foodborne organisms, U.S. Food and Drug Administration, FDA, water activity

Related Categories: LEGAL, QUALITY CONTROL, UNITED STATES PHARMACOPEIA CONVENTIONS, DOSAGE FORMS/DRUG CARRIERS

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