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Analytic Methods Used in Quality Control in a Compounding Pharmacy

Author(s):  Allen Loyd V Jr

Issue:  Jan/Feb 2017 - Volume 21, Number 1
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Abstract:  Analytical testing will no doubt become a more important part of pharmaceutical compounding as the public and regulatory agencies demand increasing documentation of the quality of compounded preparations. Compounding pharmacists must decide what types of testing and what amount of testing to include in their quality-control programs, and whether testing should be done in-house or outsourced. Like pharmaceutical compounding, analytical testing should be performed only by those who are appropriately trained and qualified. This article discusses the analytical methods that are used in quality control in a compounding pharmacy.

Related Keywords: Loyd V. Allen, Jr., PhD, RPh, analytical testing, regulation, regulatory policy, quality control, sample selection, sample storage, sample stability, analytical laboratory, dosage forms, out-of-specification results, drug potency

Related Categories: ENVIRONMENTAL , QUALITY CONTROL, DOSAGE FORMS/DRUG CARRIERS, STORAGE

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