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Basics of Compounding: Implementing United States Pharmacopeia Chapter <1163> Quality Assurance in Pharmaceutical Compounding, Part 3: Testing

Author(s):  Allen Loyd V Jr

Issue:  Jul/Aug 2012 - Volume 16, Number 4
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Abstract:  A good quality-assurance program is guided by written procedures that define responsibilities and practices that ensure compounded preparations are produced with quality attributes that are appropriate to meet the needs of patients and healthcare professionals. It also contains a testing or preparation evaluation component to provide feedback on the accuracy and repeatability of the procedures used in the pharmacy. As a final check, the compounder shall review each procedure in the compounding process to verify it has been followed correctly. To ensure accuracy and completeness, the compounder shall observe the finished preparation to ensure that it appears as expected and shall investigate any discrepancies and take appropriate corrective action before the prescription is dispensed to the patient. In addition, testing may be required or recommended depending upon the situation.

Related Keywords: Loyd V. Allen Jr., PhD, RPh, quality assurance, United States Pharmacopeia Chapter <1163>, USP, testing, analytical methods, standards, sampling, microbiological contamination, weight assessment, dosage forms

Related Categories: QUALITY CONTROL, UNITED STATES PHARMACOPEIA CONVENTIONS

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